Medrio Blog

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How eSource Optimizes The Clinical Site Experience

September 7, 2021

Trial sites are a cornerstone of clinical research but are often overloaded with a myriad of complex, manual, and time-sensitive tasks. How can sites be expected to create a positive patient experience, ensure safety and efficacy, or provide accurate study data to sponsors if their processes are manual or riddled with inefficiencies?  Decentralized eSource solutions are helping sites simplify complex workflows, reduce redundancies, and maximize their protocol efficiencies so they can focus on what matters most—their patients. We will explore how equipping clinical sites with the right eSource technology can result in positive outcomes for sponsors and CROs.  Say Goodbye to Paper Once and For All In the era of digital health trackers and electronic consent forms, it’s hard to imagine that some companies still rely on paper. But they do — lots and lots of paper. One study found that the average 1500-bed hospital prints over 8 million pages per month, totaling about $3.8 million in resources annually.1 Even worse, 76% of healthcare organizations that use an EHR platform admitted to using paper consent forms.1  When sites rely on paper processes, it can result in major disturbances to your trial, including: Sponsors and CROs should make it a point to completely eradicate paper from their site workflows. eSource solutions unlock the power for paperless data entry and all trial stakeholders will benefit from these decentralized technologies.  Sites are free of the burden of storing and keeping track of cumbersome amounts of paper CRFs. Beyond space efficiency, site staff can achieve eClinical efficiency. EDCs that sync directly with your eSuite of Direct Capture, ePRO/eCOA, RTSM, and telehealth integrations give sites the power to manage end-to-end study operations from a single source of truth. No more waiting on manual entry or length validations thanks to a host of automatic edit checks, skip logics, and missing data alerts.  Calculated variables offer protection against human error on the part of the user, and protocol changes sent down from the sponsor are easy to implement at the site level. These features offer sites a level of efficiency in their data entry and confidence in their data security that is virtually impossible with paper-based data capture. Also Read: ePRO vs Paper Strategies in Clinical Trials Providing Regulatory Peace of Mind Whenever a game-changing technology arrives in a heavily regulated industry like clinical research, it should come as no surprise when compliance concerns arise. How can sites and other interested parties be sure that a new eClinical tool is aligned with all of the many facets of the regulatory frameworks that govern clinical research? Any eSource user with this concern should find it reassuring that the FDA fully backs eSource, and has released guidance for its use in clinical trials.3 In 2020, as a direct response to COVID-19, the FDA released additional guidance surrounding decentralized eSource technology.4   Medrio’s investments in compliance are particularly strong. Medrio’s eSource applications, like all Medrio products, are fully compliant with HIPAA, 21 CFR Part 11, GDPR, and ICH GCP, and more. Our key compliance features such as SSL encryption, single sign-on (SSO), audit trails, and pre-validated environment are all purpose-built to help you maintain a strong security posture so sponsors, CROs, and your sites can have peace of mind.5  Automate Redundancies and Increase Site Efficiencies  eSource was created to alleviate trial burden, not increase it. Yet, due to the growing number of data sources and endpoints collected in a given trial, sites can feel overwhelmed managing what’s expected of them.  eSource that funnels through a unified decentralized trial management suite can help sites sift through the noise by automating redundant processes and strategically supporting in-clinic workflows with virtual ones.  Patient recruitment and enrollment efforts can be aided by eSource workflows such as telehealth screening visits and electronic consent on a web-based portal. Both solutions remove heavy patient burdens surrounding site-based travel and informed consent while allowing sites to manage the entire process from a single dashboard. Offline and remote data entry capabilities ensure sites can maintain visibility and data quality anytime, anywhere. eSource access can be restricted based on user credentials to protect data security and all data transfers to the sponsor are encrypted.  This kind of convenience extends beyond data entry and navigation: eSource also makes it possible for monitors to view data remotely, significantly reducing the necessity of site visits. As such visits typically entail a great deal of preparation on the part of the site, this amounts to a major alleviation of what can be a stressful process. This was put to practice when Swing Therapeutics leveraged Medrio’s eSource for their first hybrid decentralized study. Their sites were feeling uneasy and underprepared to manage partially virtual workflows and achieve patient compliance in a remote setting. With help from a bring-your-own-device (BYOD) ePRO solution model, in tandem with SMS alerts, and an intuitive interface, the site’s concerns were quickly mitigated. Not only did Swing’s sites report that they preferred telehealth visits over in-person visits, but they also commented on the ease of scheduling and convenience of the eSource system. Swing was able to improve their site relationships by using technology that their patients and sites preferred and the study successfully conducted virtual telehealth visits while achieving 97% patient compliance.6  Discover the Medrio eSource Difference It’s difficult to dispute that eSource delivers major time and cost savings to clinical trial sponsors. But the right kind of eSource products can be a source of convenience and comfort for site staff as well. It is this understanding — that the technology can be a boon for all parties involved with the clinical research process — that has earned Medrio a position at the forefront of the eSource revolution.

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Patient Data Privacy: What You Need to Know for Successful Clinical Trials

September 6, 2021

Protecting a patient’s personal health information (PHI) is integral to the success of clinical research. Although clinical researchers generally understand the need for PHI protection, experts are finding that some professionals don’t know how to incorporate PHI protection into their study design or protocol implementations. Even experienced researchers demonstrated inappropriate, unnecessary, or complicated techniques for protecting PHI—such as collecting the date of birth and date of service to calculate the age at the date of service.1   Inadequate privacy preparation can result in lengthy reviews and delayed approvals by Institutional Review Boards (IRBs), jeopardize trust in the patient-clinical relationship, and result in costly delays to your trial timelines. This article will aim to address common issues and gray areas related to collecting and protecting PHI, as well as proven ways to enhance compliance with HIPAA regulations.  Defining PHI PHI refers to any information in a patient’s medical record or designated record set that can1: PHI spans over 18 specific identifiers, according to HIPAA guidelines2. This includes demographic identifiers, direct identifiers, and biometric information such as facial images, fingerprints, and genetic information.  There’s a common misconception that all health information falls under HIPAA’s definition of PHI, but there are some exceptions. For example, health trackers that collect heart rate and blood pressure are considered PHI under HIPAA rules when the information was recorded by a healthcare provider or as part of a health plan. However, if a device manufacturer or app developer has not been contracted by a HIPAA or the research is not being used for healthcare services, the data does not meet the qualification for PHI. Furthermore, self-standing health information (without identifiers), such as a dataset or vital signs, does not constitute as PHI. The Devastating Consequences of Data Breaches  As more health records become electronic, the risk associated with storing and transferring them increases. For example, in 2020, there were more large healthcare data breaches than any other year on record, impacting millions of individuals and exposing their sensitive PHI.3 Over 642 significant data breaches were reported by healthcare providers last year—25% more than in 2019 and three times the number of breaches reported in 2010.3 These breaches can stem from several issues, including hacking, theft/loss, unauthorized access, improper disposal of sensitive data, or sharing data across unsupported systems and networks. Whatever the reason, the problem is clear: health records are susceptible to a multitude of security issues and require a coordinated, comprehensive approach to protect them from falling into the wrong hands.  Ways to Reduce PHI Issues  Although there is no golden solution for protecting PHI, you can take steps to reduce risk and maintain a strong security posture.  1. Have a robust plan for data collection, storage, sharing, and reporting  Data management plans are necessary for clinical research, where trial operators are responsible for securely collecting, managing, and storing sensitive records and PHI.4 During the initial planning phase, research teams should create a comprehensive data management plan that accounts for: Building out a thorough data management plan provides your research team with a complete understanding of the data requirements for a project and the preparation needed to protect it. Once the data management plan is created, setup and data collection can be checked for consistency against the patient intake and consent forms.  The data management plan should be treated as a living document. Although it is created during the project development stage, it should be regularly reviewed and updated to align with mid-study changes and protocol adjustments. Be sure that your data management plan also carries through study close-out and post-publication, where data sharing and reporting is still critical.  2. Avoid Unnecessary Collection of PHI The truth is that sometimes the easiest way to avoid issues collecting PHI is to avoid collecting it in the first place. Some PHI is necessary to analyze data in accordance with study objectives and outcomes. But consider the following scenarios when determining which PHI is necessary to your study’s success: 3. Limit Admin Access to PHI Due to the number of stakeholders involved in complex clinical trials, patients’ PHI may need to be shared across several dispersed teams and sites. In addition to balancing the risk to privacy and identity of patient PHI, researchers should have a process for safeguarding who has access to this information.  Thankfully, many data management solutions have pre-built user-level access so trial operators can designate which roles have access to which level of information. Experts suggest building that framework in tandem with the following steps: 4. Source Infrastructure that is secure by design Protecting patient PHI is increasingly difficult as the number of data endpoints rises and researchers falter under lakes of data. Trial operators need solutions that are secure by design and scalable to support all study phases. Medrio supports higher data security standards that start at the core of our EDC and extend through all software in our unified ecosystem. Our servers are secure and encrypted using a multi-layered approach that protects data at the database file level. Any change to a data endpoint is subject to electronic audit trails and redundant monitoring to ensure your PHI is always safe. Automatic backups of customer data and server maintenance are automatically conducted and protected by a continuously updated firewall protection.  Our user-restricted access and encrypted data sharing allow for confident collaboration between teams to further reinforce data integrity.  You may not always be able to predict or prevent harmful risks to your patient data. But Medrio’s pre-validated, fully-compliance ecosystem and best-in-class support team are here to support a better security stance.  Are you ready to protect your patient PHI? References  1 Marjorie A. Bowman, Rose A. Maxwell, A beginner’s guide to avoiding Protected Health Information (PHI) issues in clinical research – With how-to’s in REDCap Data Management Software, Journal of Biomedical Informatics, Volume 85, 2018, Pages 49-55, ISSN 1532-0464, https://doi.org/10.1016/j.jbi.2018.07.008. 2 What is Considered PHI Under HIPAA? 3 2020 Healthcare Data Breach Report: 25% Increase in Breaches in 2020 4 Mary Williams, Jacqueline Bagwell,

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Medrio and PHASTAR Unite to Offer Data Visualization for Clinical Trials

August 31, 2021

Medrio, Inc. a leading provider of decentralized and eClinical technology to pharmaceutical, biotech, medical device, diagnostics, and animal health markets and PHASTAR, a global specialist biometrics clinical research organization (CRO) offering industry-leading data management, data science, statistical consulting, and clinical trial reporting services, announced today that they have partnered to leverage metadata surrounding electronic patient-reported outcomes (ePRO) for advanced data visualization, providing insight into patient compliance and burden. PHASTAR ran a pilot with 33 volunteers completing EQ-5D, a health-related measure of quality-of-life questionnaire, to understand how metadata may be used effectively to monitor ePRO data collection during a study. “Whilst sites may monitor compliance at the individual subject level, data management teams can take a broader view. We looked at how the metadata surrounding the ePRO data can be used to monitor compliance, patient burden, and any anomalies that may ultimately impact the interpretation of the results,” explained Jennifer Bradford, Director of Data Science at PHASTAR. The PHASTAR team used Medrio ePRO for initial data collection and Medrio’s Export API to funnel the ePRO and metadata into PHASTAR’s data visualization tool, PHIZUAL. “Data visualization provides data management teams the ability to monitor compliance and see any anomalies in real-time, ultimately providing the highest quality data reflective of the patient population as a whole rather than at the subject level,” detailed Bradford. Bradford also stated that “this wouldn’t have been possible without Medrio’s ePRO and Export API. These tools offered us an intuitive customer and patient-friendly experience while seamlessly integrating the data we needed. We would not have been successful without the flexibility and agility that Medrio provided along with their world-class support team.” “Medrio is thrilled to support and enable data visualization with PHASTAR. At Medrio we continuously look to be innovative and stay ahead of the curve to provide efficiencies and accurate data that serve not only our sponsors and CROs but the patients as well. Getting a holistic view of patient data is a necessary piece to the democratization of clinical trials. We look forward to continuing to work with PHASTAR on improving data quality and accuracy,” said Fred Martin, Chief Product Officer of Medrio. View the official press release here: prweb.com About Medrio At Medrio, we believe that clinical trial technology shouldn’t be difficult to use. That’s why our full-service eClinical Data Management suite helps streamline and decentralize your research and unify your solutions so you have more time to focus on your patients, rather than multiple vendors. Since 2005, our flexible technology has evolved alongside our customers to include an integrated suite of EDC, DDC, eConsent, RTSM, and ePRO/eCOA solutions that support your teams and sites, while reducing patient burden. Let our solutions put you back in the driver’s seat with adaptive technology that easily powers mid-study changes and accelerates your trials, without compromising data quality. Or lean on our global team of experts who are available 24/7 to support you where you need it most. We’ve worked alongside Sponsors, CROs, and sites—spanning all therapeutic areas and trial phases—to secure over 770 approvals because we know it takes a village to achieve a healthier world. Discover the Medrio difference today by visiting us at medrio.com. About PHASTAR PHASTAR is a global specialist biometrics contract research organization offering industry-leading data management, data science, statistical consulting, and clinical trial reporting services by providing expert consultants and managing and delivering in-house projects, FSP style arrangements, and preferred partnerships. PHASTAR currently has over staff across 14 offices (United States, United Kingdom, Australia, Germany, Kenya, Japan, India, and China) with plans to open additional locations in the future to serve prospective and existing clients. PHASTAR’s number one priority is to ensure that the work produced is of the highest quality. Every project PHASTAR undertakes utilizes unique internal processes which are designed to ensure optimal quality. All PHASTAR’s statistical, programming, data management, and data science staff are trained in the “PHASTAR Discipline” – an in-house approach to data analysis and collection. This comprises a set of common sense (but commonly ignored) principles that, if followed, guarantee error-free outcomes. The “PHASTAR Discipline” also includes a series of intranet-based checklists highlighting potential pitfalls and points to consider when conducting clinical trials, enabling over 4,000 years of combined technical knowledge to be shared across the company. For further information on PHASTAR contact tellmemore@phastar.com

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Medrio Partners with PHARMASEAL International Ltd.

July 23, 2021

PHARMASEAL International Ltd, a technology provider of clinical trial management and governance solutions for biopharmaceutical, CROs, and medical device organizations, and leading hybrid and decentralized trials software organization, Medrio have announced that they have entered into a partnership agreement. “This partnership allows us to offer customers a fully integrated eClinical solution that supports trials in all phases. By joining forces with Medrio,  we will simplify clinical trial management for customers with more user-friendly interfaces, reduced data duplication, and improved trial management visibility, along with the adaptability to suit the needs of different clinical trial designs” said Daljit Cheema, Founder & CEO at PHARMASEAL. The combination of Medrio’s integrated platform of EDC, eConsent, ePRO, eCOA, Direct Data Capture, and RTSM with Engility®—PHARMASEAL’s dynamic CTMS, eTMF, and payments capabilities system—will streamline research by enabling collaboration, agile processes, and enhanced study oversight. Additional benefits include transparent interoperability between PHARMASEAL and Medrio’s eClinical solutions, real-time data sharing, and scalable workflows that support larger, later-phase studies. “We’re thrilled to partner with PHARMASEAL to offer our customers a world-class CTMS and eTMF solution that seamlessly integrates with Medrio’s flexible data collection and management tools. Medrio customers expect innovative, agile, and high-quality solutions. PHARMASEAL meets those expectations while also mirroring our customer-first mindset and shared objective of simplifying trial complexities.   At Medrio, we recognize the value of partnership and that together we are stronger. We are looking forward to continuing to deliver high-quality data and operational excellence to our customers alongside PHARMASEAL.” – Fred Martin, Chief Product Officer, Medrio For more details about how PHARMASEAL and Medrio can support your next project please contact sales@medriostagepwa.wpengine.com About PHARMASEAL PHARMASEAL was founded in 2016 by a team of industry leaders who share a vision to create smarter technologies and innovative products for the improvement of human health. The company’s SaaS platform Engility® simplifies the management and control of clinical trials for biopharmaceutical, CRO, and medical device companies. Engility® utilizes advanced engineering offering enterprise management with rapid deployment, an intuitive user interface, and interoperability with other eClinical applications to optimize trial governance and oversight. For more details please visit www.pharmaseal.co  About Medrio Take control of your clinical research and studies with Medrio’s full-service suite of eClinical Data Management solutions. We’ve been innovators in the clinical trial technology space since 2005, evolving alongside our customers to meet the demands of today’s world. Our integrated platform of EDC, DDC, eConsent, RTSM, and ePRO/eCOA are configurable to meet any trial needs—from traditional to hybrid, or fully remote studies. That’s why sponsors, CROs, and clinicians across all therapeutic areas have leveraged our adaptive, unified technology to power clinical trial breakthroughs and secure over 770 regulatory approvals.  Our robust suite of tools was designed to offer you full functionality—without complexity—so you can streamline your study builds and focus on what matters most: your patients. While other eClinical vendors make similar claims, few can deliver the same white-glove customer service paired with patient-centric, proven clinical trial technology. Discover the Medrio difference and see what makes us your most strategic and successful partner. Learn more at medrio.com. 

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4 Reasons Decentralized Trials Are Here to Stay

July 6, 2021

Long before the global pandemic, clinical trial sponsors were consumed with accelerating their studies and improving the trial experience for key stakeholders. Decentralization emerged as a leading factor in this pursuit. As COVID-19 inundated healthcare facilities and disrupted clinical research, it also catalyzed the adoption of decentralized solutions.  When health resources shifted priorities to COVID-19-related needs, patients’ trial site access reduced by 80 percent and trial starts declined by 50 percent between January and April 2020.1 As a result, the industry was forced to adopt decentralized clinical trials solutions to address growing challenges with remote trial activities and engaging with dispersed patients.  Although the pandemic isn’t behind us yet, trends are suggesting that decentralized trials are here to stay. One survey found that 98 percent of trial participants were satisfied with telemedicine.2 And 72 percent of physicians reported similar or better experiences using remote engagement tools compared to in-clinic visits.  The response from the industry suggests that decentralization is not a fleeting fad. But what does the future of decentralized clinical trials look like? We will explore emerging trends resulting from decentralized trials during COVID-19 and what they suggest about the future of DCT.  1. Growing Comfort with Health Technologies Social distancing and mandated stay-at-home orders had a big impact on society’s relationship with technology. Traditional workplaces transitioned to remote environments and leveraged communication and collaboration tools to connect dispersed teams. Fitness wearables boomed as companies like Apple, Peloton, and Strava made it easy to monitor your health anywhere. Remote telehealth visits for primary care physicians and mental health specialists became commonplace.  As a result, physician and patient comfort with remote technologies grew significantly during 2020.1 At the height of the pandemic, physicians reported using remote technologies for nearly 80 percent of sponsor and 57 percent of patient interactions.1 Experts believe that as comfort levels continue to grow, the clinical trial industry will experience a threefold increase in remote patient interactions after the pandemic.  Image Source 2. Technological and Regulatory Maturity As decentralized tools for remote data collection mature—including camera, voice, touch, video, actigraphy, sensors, eCOA, and more—they are also being increasingly validated. These pre-validated technologies are helping encourage broader use across the industry.  Similarly, regulatory acceptance prompted by the pandemic has led to new guidance permitting the use of decentralized clinical trial technologies. These include remote monitoring, direct-to-patient IP shipments, hybrid and virtual trial sites, telehealth, and more. As acceptance and adoption become more mainstream, experts anticipate this trend will carry on long after the pandemic. A 2021 report found that 80% of sites and 83% of sponsors plan to conduct all or most of their monitoring visits remotely by 2023.3  3. Shift in Focus Towards Patient-Centricity  The clinical trial industry initially pivoted towards decentralized trials as a temporary measure against COVID-19. But as a greater number of trials implemented hybrid and virtual studies, it became clear the impact it can have on patient recruitment, retention, and adherence.  Decentralized technologies accelerate and aid patient recruitment by widening the pool of potential patients. Removing physical barriers from clinical research allows trials to better engage with patients living in remote areas or underserved communities, who would historically be excluded from participating. They also enable better patient diversity by creating a wider pool of participants instead of limiting it to those living closest to the trial site and reducing barriers that predominantly impact minority communities. Once patients are enrolled, there is evidence that decentralized eConsent and eCOA forms help patients become more knowledgeable, informed, and engaged in their trial experience.4  Study managers benefit from decentralized technologies by gathering more diverse and applicable data that aids result in meaningful study outcomes. As patients and physicians realize the impact of decentralized technologies on patient-centricity, their expectations are changing. Patients want to feel like active participants in their care and decentralization is giving them the autonomy to do that.  4. Emphasis on Real-World Evidence In June of last year, the FDA announced its COVID-19 Diagnostics Evidence Accelerator that used real-world evidence (RWE) to inform the agency’s response, drive collaboration, and accelerate timelines.5 This prompted an even greater emphasis on the industry to move towards evidence-based decisions to drive better patient outcomes while keeping studies on time and on budget.  In a 2020 Deloitte report, 80% of organizations said they were actively working on increasing access to real-world data sources.5 Decentralized solutions that support remote data collection and sharing across dispersed teams are helping to accelerate this trend. The data generated is helping researchers better understand the burden of diseases, how to monitor patients’ safety, and streamline processes. In fact, a recent study leveraging decentralized RWE was able to reduce their sample size for phase III studies by 40%.5  Experts anticipate that RWE will evolve to support more nuanced cases like regulatory submissions, informing value-based contracts, and building synthetic control arms. Until that point, 94% of organizations say RWE will be important or very important to their organization moving forward.  Embracing Decentralization for the Future As decentralized technologies evolve, it will be interesting to see how they continue to support and streamline manual clinical trial processes. The pandemic propelled the industry toward digitalization and the world is watching to see how that impacts clinical research moving forward. As sponsors and CROs look to embrace decentralized solutions, it’s imperative that they carefully consider which technologies will help them scale and grow for the future.  Medrio has been helping sponsors and CROs decentralize their studies long before COVID-19. Let us help you embrace decentralization through flexible, scalable workflows that support traditional, hybrid, and virtual trials. Spend less time managing vendors and more time on your patients by embracing decentralization today. References: 

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Medrio Selected as Exclusive Data Management Solution for PAVmed

June 24, 2021

Medrio, Inc., a leading provider of decentralized and eClinical technology to pharmaceutical, biotech, medical device, diagnostics, and animal health markets, has been selected as the exclusive data management vendor for PAVmed Inc. (Nasdaq: PAVM), a multi-product, commercial-stage medical technology company and its major subsidiary Lucid Diagnostics, Inc.  Earlier this year PAVmed made the strategic decision to bring its data management in-house to gain full control of its studies. “We considered a number of EDC (electronic data capture) providers and chose Medrio because it has an excellent track record, a user-friendly system, and truly values the business of small to mid-sized organizations,” explained Randy Brown, Executive Vice President of Clinical Development of PAVmed. PAVmed and Lucid Diagnostics anticipate significant annual savings from this move to in-house data management.  Customer service was another important factor in PAVmed’s decision. “It was important for us to select a vendor who is responsive and supportive of their customers, no matter the size of the organization. Often small to mid-sized companies can get lost in the shuffle, but we felt Medrio would be best suited to handle a fast-growing company of our size,” explained Brown. Medrio’s customer service team boasts a 98% satisfaction rating along with 91% of all support requests being addressed in under 10 minutes. “Our solutions are designed with smart technology and AI (accuracy intelligence) to be flexible and agile enough that you can manage our tools without costly programming or third-party interventions – our intelligence technology does it for you. Delays can make or break a study, so the sooner you can get up and running, the better. With Medrio we can get your study up in less than two weeks—compared to the industry average of twelve. And we don’t just hand you the technology and walk away. We wrap you in support throughout your study, ensuring your success, while you maintain control over your data. It’s the Medrio differentiation and why our customers trust and partner with Medrio to grow their business,” detailed Fred Martin, Chief Product Officer of Medrio.  “We’re proud to support PAVmed and Lucid Diagnostics and to continue our mission of building a healthier future,” said Martin. About Medrio At Medrio, we believe that clinical trial technology shouldn’t be difficult to use. That’s why our full-service eClinical Data Management suite helps streamline and decentralize your research and unify your solutions so you have more time to focus on your patients, rather than multiple vendors. Since 2005, our flexible technology has evolved alongside our customers to include an integrated suite of EDC, DDC, eConsent, RTSM, and ePRO/eCOA solutions that support your teams and sites, while reducing patient burden.  Let our solutions put you back in the driver’s seat with adaptive technology that easily powers mid-study changes and accelerates your trials, without compromising data quality. Or lean on our global team of experts who are available 24/7 to support you where you need it most. We’ve worked alongside Sponsors, CROs, and sites—spanning all therapeutic areas and trial phases—to secure over 770 approvals because we know it takes a village to achieve a healthier world. Discover the Medrio difference today by visiting us at medrio.com.  

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5 Ways ePRO Boosts Patient Engagement

June 22, 2021

Collecting patient data is a necessary and critical step in clinical research. When done well, it can be fundamental in determining the safety and efficacy of an intervention. But finding ways to keep patients engaged and informed throughout the course of a trial continues to plague researchers, especially when the study requires patients to manually report outcomes or track diaries between site visits.  Electronic patient-reported outcome (ePRO) solutions are helping bridge the gap between patient-centric workflows that engage patients while generating higher quality, more reliable data that successful studies need.  Although ePRO approaches are not new, it took COVID-19’s disruption to clinical research to garner wider acceptance of remote data capture and monitoring solutions across the industry. A greater willingness—paired with growing regulatory acceptance of decentralized technologies helped sponsors and CROs implement ePRO on a larger scale and realize the impact it can have on patient retention, compliance, adherence, and engagement.  As the industry looks ahead at the future of post-pandemic trials, it’s important to consider the role ePRO plays in patient engagement and how to harness it moving forward.  1. ePRO Meets the Demands of a More Digital Generation  More than a quarter of clinical trials use patient-reported outcomes, but less than half are estimated to use electronic systems to capture PRO responses. Sponsors and CROS commonly cite the high cost of digital solutions, complex workflows, and resistance from sites as leading reasons why they still implement paper-based PRO approaches. But patients continue to reaffirm their preference for digital solutions. A 2016 study by Deloitte Centre for Health Solutions found that 31% of responding patients would be more likely to participate in clinical research if it offered a mobile app.1 That same study found that there were over 260,000 health apps worldwide and 70% of patient groups reported using at least one app to manage their condition. These numbers are important when you consider that nearly 90% of healthcare consumers are estimated to have low health literacy.2 Individuals in this group struggle to adhere to treatments, provide informed consent, or enter accurate and complete data into PRO diaries. Digital solutions that leverage commonly used technology, such as mobile devices or tablets, are allowing patients to engage more comfortably with devices they use for personal and health reasons every day.  Engaging with patients on mobile or web-based devices helps drive better patient outcomes, compliance, and adherence. This can be further reinforced when ePROs implement “bring your own device” (BYOD) models where patients can record and access health information from their personal mobile device or wearables.  While paper-based collection may appear easier for patients to use and record at their convenience, ePRO can implement skip logic, data validation, and automatic alerts for missing data to ensure the right information is being collected. Access to personalized reminders about site visits or dosing schedules, notifications with clear instructions, and content enriched with media all strengthen patient engagement and comprehension while making patients more autonomous in their health journey.  2. Real-Time Insights Power a Proactive Response  Clinical trials are growing more complex, creating a greater need to improve visibility and oversight of data collection. With paper-based PRO approaches, data is prone to delays, littered with human errors, and requires thorough data validation to ensure its accuracy.  ePRO approaches transform trials to be more patient-centric and proactive by allowing real-time data collection, sharing, and analysis across remote and in-clinic teams. With automatic data validation workflows, you can view patient-reported outcomes immediately and respond to adverse events (AE) more quickly while trusting that your data is accurate.  Clinicians benefit from real-time insights into patient-reported and clinical data, as well as live visibility into patient adherence. Patients benefit from increased safety knowing that their protected health information (PHI) is secure, supported by audit trails, and shared directly with their healthcare team for immediate response. This symbiotic relationship strengthens patient engagement and trust between patients and their clinical teams.  3. Increase Data Integrity for PHI When clinical teams rely on paper processes, they are leaving sensitive PHI vulnerable to transcription errors, form misplacements, or data inaccuracies. Pre-validated ePRO solutions help improve data quality while strengthening patient engagement in the following ways: Also Read: ePRO vs Paper Strategies in Clinical Trials 4. Improve Patient Comprehension and Compliance  One of the biggest challenges facing clinical research is keeping patients enrolled and compliant throughout the duration of a study. As many as 30% of patients are estimated to drop out of trials, but research confirms that patients are more compliant when using electronic devices to record outcomes over paper diaries.3 In fact, compliance levels exceed 90% using electronic reported outcomes, compared to 11% with paper-based methods.  This stems from the fact that protocol compliance tends to increase and drop-out levels tend to fall when patients are more engaged with a trial. ePRO engages patients while strengthening compliance, in the following ways: 5. Unified ePRO Positions Patients as Partners  Patients and their families are inherently impacted by study protocol and technology as they go through a trial. In one device study, a patient may interact with wearables, reminder apps, eConsent, and an e-Diary. These technologies may run on disparate systems that require specialist vendors and a learning curve for patients to understand unique access points and compliance requirements. Unifying ePRO with your larger eClinical suite not only reduces the burden of managing a clinical trial, it’s also been found to reduce patient dropout rates by as much as 50%.4 Streamlining all clinical and patient-reported data creates a unified user experience, reducing complex burden that leads patients to quit studies or deviate from protocol.  How ePRO benefits each stakeholder with patient-centric workflows: Boost Your Patient Engagement with Medrio ePRO  Not all ePROs are created equal. As patient-reported outcomes become a more critical component of engagement, it’s imperative to have a trusted, unified ePRO solution behind you.  Medrio ePRO handles all of the complexities of patient-reported data—from flexibility to support in-clinic and remote data collection, to supporting a variety of validated survey instruments.

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How to Address Early Obstacles in Phase I

June 10, 2021

It’s no secret that getting new drugs or biological products approved by the FDA is a challenging task. The low rates at which drugs make it all the way through the research process is a favorite topic of blogs and journalistic outlets alike. Some drugs fall by the wayside due to unfavorable efficacy or underpowered data in the middle and later phases. Many others, though, fall victim to administrative or technical challenges that arise as early as the nascent stages of phase I.  What steps can sponsors and CROs take to position their early-stage studies for success and expedite their final market approval? In this article, we’ll explore three obstacles that researchers face early in phase I studies, as well as some insight into how the right eClinical suite can overcome those challenges. Challenge #1: Phase I Recruitment Across all phases of research, challenges in patient recruitment are often accounted for by a lack of awareness and skepticism of the tested compound’s efficacy compared to existing treatments. Recruitment challenges in phase I, however, have their own additional causes.The most notorious of these is the “guinea pig” fear: as the drug’s safety and tolerability profiles have not yet been established, potential subjects often worry it may pose a danger to their wellbeing.1 Clear and concise communication between patients and clinicians is critical in phase I to dispel any fears and discuss what is expected during the trial. Yet, unclear or incomplete physician communication during the enrollment process of phase I trials is a leading source of patient dropout. Nearly 30% of phase I trial participants reported that their clinician did not fully address the impact that the trial could have on their quality of life.2 When phase I participants were able to discuss their fears and concerns about participating in research with a healthcare provider, it was shown to increase their comfortability and autonomy with decisions about their enrollment.2  Creating opportunities for patients to engage with their healthcare team is critical to not only answer their questions, but also to build confidence, trust, and appreciation. Lack of motivation is another common factor, as most phase I trials involve healthy volunteers with no medical necessity for the tested compound. The exception to this, of course, is phase I oncology trials, which enroll sick patients. But even here, patients with an advanced condition and limited time are often reluctant to try a treatment with undetermined efficacy. To combat this, healthcare teams should find ways to show appreciation for the role patients play in the success of early-stage studies.  Challenge #2: Site Negotiations Before dosing begins in a clinical trial, there is a period of negotiation dedicated to hammering out details related to administrative matters like site payments. Most sponsors aim to complete site negotiations within 20 days, but due to the unpredictable nature of negotiations, 23% of discussions extend beyond 60 days.3   The time spent on negotiations with clinical research sites tends to decrease as research moves from one clinical phase to the next. This is due to the fact that as research progresses, the protocol becomes better established and there are fewer unknowns in the budgeting process. Therefore, it follows that the negotiation period tends to be longest in phase I. In fact, phase I site negotiations often last more than twice as long as other phases3. These lengthy negotiation periods threaten to derail timelines even before research has begun. To combat this challenge, sponsors should aim to build scalable processes that sprint their early-stage negotiations: Challenge #3: Protocol Uncertainties As phase I oncology trials enroll sick patients instead of healthy volunteers, eligibility criteria can be strict and dropout rates are notoriously high. This places the protocols of these trials at particularly high risk of unexpected changes.  A study by the Tufts Center for the Study of Drug Development found patient recruitment struggles to be a common cause of protocol amendments, with many amendments aiming to change patient eligibility criteria.4 Additionally, 57% of protocols had at least one amendment, and nearly all amendments were deemed as “avoidable”.  Outside of oncology, there is another risk: the Tufts study reported that 40% of protocol amendments take place before patient enrollment begins, and therefore create delays in the nascent stages of a trial that may be difficult to recover from as research progresses.4 Although some mid-study changes are unavoidable, there are steps sponsors can take to minimize their impact on early-stage study budget and timelines: An eClinical Solution to Overcome These Obstacles With these challenges lying in wait, researchers can benefit from entering their phase I trials equipped with the tools necessary to address them. The right eClinical solution can provide both mitigate and streamline early phase I challenges.  Medrio’s EDC makes it easy to perform mid-study changes, a feature that eases complications arising from protocol amendments. And our drag-and-drop interface enables researchers to build studies in weeks instead of months, creating time savings that can offset any delays stemming from patient recruitment or site negotiations. Best of all, our integrated eSuite empowers sponsors across all phases of clinical research to accelerate their studies while maintaining control and reducing costs.  The outcomes of phase I trials set the tone for the rest of the research process. The value of a strong start is impossible to overstate. While these trials face considerable challenges in their early stages, a robust and intuitive eClinical like Medrio is available to mitigate those challenges. References:

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How to Strengthen Trial Retention Through Patient Education

April 30, 2021

According to a 2019 CISCRP study, 85% of the general public are willing to participate in clinical trial research. Yet, recruitment continues to plague the industry as one of the most costly and timely parts of conducting a trial. Even worse, once studies are underway, teams still need to worry about patient retention in clinical trials and patient drop-out and adherence.  Patient withdrawal or non-adherence can stem from a variety of factors including geographical and financial constraints, fear and anxiety, or feeling a lack of appreciation. Whatever the specific reason, the underlying problem is the same:  Patients lack critical information about how to find a trial, what the trial will involve, and how the trial will affect their current well-being.  These lapses in information exchanges may result in additional recruitment for your sites or result in too many dropouts that make your trial underpowered. Patient education is helping clinical teams strengthen their recruitment and retention efforts by creating healthy information and data exchanges. Understanding the importance of patient education throughout the entire trial lifecycle helps to examine the unintended consequences of uninformed patients and then look at how education efforts are bridging the gap for clinical trial recruitment and retention.  Patient Education’s Impact on Recruitment Patient recruitment continues to plague researchers, with the average trial extending recruitment timelines by up to 71%. And each day a trial is delayed due to recruitment, it can end up costing sponsors between $600,000 – $8 million. But, why does recruitment continue to be so cumbersome for researchers, sites, and patients alike? For decades, clinical trial recruitment largely relied on word-of-mouth or paper-based processes. Also Read: ePRO vs Paper Strategies in Clinical Trials Patients would traditionally hear about available studies from their primary physician, who might have limited details on the specifics of the trial and how it would impact their long-term health. Then they might be asked to travel upwards of 2 hours to the nearest site to begin a screening process they knew very little about.  But as the global pandemic forced the clinical research industry to start replacing paper processes and focus on patient-centric technology, it still begs the question—why does recruitment continue to suffer?  The answer stems from a few reasons: In short: lack of clinical trial awareness continues to be one of the biggest barriers to patient entry in clinical research.  Patient education and awareness are critical in the recruitment stage because eligible patients still aren’t aware of where to find available trials, what they involve, or how to provide informed consent. And studies continue to show us that when patients don’t understand trials, they won’t participate in them.  The Damaging Impact of Uninformed Patients on Study Success Beyond recruitment, patient education plays an important role in retention and overall patient satisfaction with a research study. With traditional trial operations, patients face a rising number of burdens for participation. From time commitments, travel obligations, informed consent, and treatment expectations—it’s easy to understand why patients feel motivated to withdraw from a study.  A survey comparing the experience of patients who dropped out of a trial vs. those that completed a trial found striking differences in their level of understanding what was expected of them:  Educating patients throughout the process can help dispel fears and answer questions that strengthen adherence and compliance. The more clearly a disease or treatment is understood, the more likely it is that your patient will be comfortable with their care and adhere to the necessary treatment. Learning about their condition and available interventions through educational programs equips patients with the knowledge to undertake treatments with confidence—even outside of a traditional medical facility.  Experts from The American Journal of Medicine stated that “Patient education significantly improves compliance with medication across a broad range of conditions and disease severities. Conversely, lack of compliance is associated with poor clinical outcomes, increased hospitalizations, lower quality of life, and higher overall health costs.”  Yet, on average, healthcare professionals spend as little as six minutes training patients on the use of medication. And each time a patient withdraws from a trial due to non-compliance, it costs a sponsor 3 times as much to recruit a new patient.  Incorporating Patient Education Into Your Study Builds  The need for patient education is widely recognized in the research community. The increase in chronic illnesses, combined with limited hospital facilities, economic constraints due to U.S. healthcare, and a need for better and safer care at home greatly reinforce the importance of patient education.  Now, more than ever, clinical research needs to focus on building patient education into their study builds to boost retention rates and ensure the overall success of a study.  Improve Clinical Trial Awareness Patient education can help ensure the people who want to participate in clinical research can source and identify a trial easily. The industry used to rely heavily on physician recommendations, but nearly half of millennials don’t have a regular primary care doctor. To improve awareness and education on clinical trial availability, teams can: Establish Trust Early for Long-Term Patient Retention Patient fear and anxiety during a trial can be easily remedied when trust is established with their healthcare and clinical team. Involve patients early in your development plan and establish modes for healthy two-way communication between patients and their research team. This can be done by engaging with patient networks, hosting focus groups, conducting one-on-one interviews, or working directly with patient advisory boards or advocacy groups. You could even encourage former study participants and volunteer advocacy groups to share their clinical trial experience via social media, patient forums, and word of mouth to dispel myths and encourage new patients to come forward.  Establishing two-way communication between clinicians and trial participants is crucial for identifying the questions to ask and the outcomes to assess. It will create a more patient-centric trial workflow that leads to improved satisfaction for both stakeholders. And pre-addressing patient concerns allows clinicians to trust their patients fully understand study participation requirements and have the measures in

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How Adaptive Trial-Friendly EDC Benefits Oncology

January 28, 2021

Adaptive clinical trial design in oncology research represents an intersection of two major industry trends. One of these is the current prevalence of cancer clinical trials. Clinical Leader cited a GBI Research report that declared oncology the largest therapeutic area in the pharmaceutical industry pipeline. And the promise of immunotherapy continues to galvanize investigations into new cancer treatments. The other trend is the increasing popularity of adaptive trial designs, which have helped the industry neutralize major inefficiencies in their research — not to mention all the discussion and debate they have sparked among industry bloggers and thought leaders. As oncology research is home to a large share of adaptive trials,1 any challenges to the implementation and execution of adaptive design can have consequences for one of the biggest and most important segments of the clinical research industry. As cancer researchers assess whether they’re equipped to successfully execute an adaptive clinical trial, then, the stakes could hardly be higher. The Impact of Electronic Data Capture (EDC) The ability to manage a modern clinical trial hinges in large part not just on whether a trial uses an Electronic Data Capture (EDC) solution, but on what that particular solution is capable of. Indeed, not every EDC can handle adaptive trial designs smoothly. Some, in fact, pose significant inefficiencies, requiring studies to be taken completely offline while protocol changes are implemented. This creates a major delay that many trials with strict timelines can’t afford. Luckily, that delay is ultimately unnecessary – more modern and savvy eClinical solutions offer features that are much more conducive to adaptive trial design. Those features include: EDC brings the capabilities necessary for adaptive trials to data managers – eSource extends those capabilities all the way to the sites. And with adaptive trials on the rise, the ability to handle them smoothly is an invaluable asset for an eClinical platform. Why This Matters for Oncology Adaptive trial design is on the rise across various segments of the clinical research industry. It’s no surprise, though, that they’re pursued to such a high degree in cancer trials. The nature of oncology research, as well as the state of the field today, offer a number of possible explanations for this trend: Innovations such as immunotherapy have brought new uncertainties to oncology, and researchers can benefit from the ability to modify protocols as they learn. Challenges in patient recruitment and retention are notoriously daunting in cancer trials. If a trial misses the enrollment target set in the protocol or the enrollment total changes due to attrition, the ability to integrate those changes seamlessly into an eClinical system can be an important lifeline. The urgency of cancer patients’ conditions, even in Phase I, make the question of whether the treatments in the trials actually work even more consequential. Traditionally, researchers don’t know if a dose is effective until the end of data collection – adaptive designs allow them to modify dosage sooner, increasing the chances of effectiveness. As the trend toward adaptive trial design continues, it will become more and more important for researchers to ensure they have the tools necessary to reap the benefits. eClinical technology plays a major role in this process. Whether researchers possess the right EDC for the job could be a major factor in whether they can keep up with a challenging and evolving field like oncology or lag behind, struggling with the same challenges that have frustrated the field for years. Discover how Medrio addresses adaptive clinical trials and the complexity of oncology trials today. Success Story: TargetCancer Foundation Successfully Empowers Rare Cancer Patients with Medrio References: 1 Hatfield, Isabella; Allison, Annabel; Flight, Laura; Julious, Steven A.; Dimairo, Munyaradzi; Adaptive designs undertaken in clinical research: a review of registered clinical trials; BioMed Central; 19 March 2016

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Medrio Inc Names Nicole Latimer as Chief Executive Officer

August 17, 2020

Medrio Inc., the leading provider of eClinical technology to pharmaceutical, biotech, medical device, diagnostics, and animal health markets, announced the appointment of Nicole Latimer to Chief Executive Officer. Nicole will be replacing Mike Novotny, former CEO and Founder of Medrio as he has chosen to take a sabbatical after leading Medrio’s growth for 15 years. Mike will, however, remain on the Board of Directors. Effective today, Nicole will be responsible for the continued growth and commitment of Medrio to cure all diseases with clinical trial technology. Prior to joining Medrio, Nicole was CEO of StayWell, where she drove the company’s mission to be the premier provider of lifestyle risk management programs for the entire healthcare ecosystem, leveraging behavioral science as the foundation for improving health outcomes. Nicole has also led key initiatives for the Advisory Board and Deloitte Consulting, focusing on population health management, health system growth strategies, patient and employee education, and SaaS development and delivery. Speaking on behalf of the Board of Directors, Mike Novotny said “We are fortunate to have someone of Nicole Latimer’s caliber and experience to lead Medrio into the future. She brings decades of experience in leadership, services, and devices, and she brings a unique perspective of patient insights at a time when patient advocacy demands attention in clinical trials. I am confident that Nicole will take Medrio to the next level while remaining true to our values.” “I would like to thank Mike Novotny for his leadership, entrepreneurial spirit, and vision for the future of the organization. Since its inception in 2005, Mike has done a tremendous job cultivating a team of creative and talented individuals whose determination is evidenced by the loyalty and success of our customers. I am excited to take the reins of this incredible company and grateful for the Board’s confidence in my leadership. I am particularly fortunate to be surrounded by such a talented team as we take this company into the future,” said Nicole Latimer, CEO, Medrio.

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The Future of Informed Consent

August 7, 2020

From eClinical data collection to telehealth to wearables and beyond, the clinical trials industry has seen a mass of technological advances over the past decade. Informed consent is critical to every clinical trial, but often a daunting process from the patient perspective. The Benefits to Patients In a paper-based consenting process, many forms are 15 to 20 pages long. That’s a lot of content to consume in a short period of time. Twenty pages could take close to an hour to process, and if you factor in patient questions and concerns you could easily be looking at a multi-hour process. Studies have found that patients prefer simpler and easier to read Informed Consent Forms that can provide them the necessary information to make a decision regarding participation in the trial.1 While required by regulators, the purpose of informed consent is so that patients are aware of the benefits and possible risks associated with treatment. Consent requires patient understanding, which can be improved by using electronic tools that enable rich media content, including videos. Comprehension requires that the patient be able to understand the information presented and have the time and opportunity to read, evaluate and consider the information presented.2 Researchers have studied the merits of an electronic informed consent process and found that patients prefer this method over paper for a number of reasons. Patients felt the electronic process was less stressful because it gives them a greater sense of control and allows them to proceed at their own pace. They liked the hierarchic and modular approach to providing information and felt that the use of video made information more understandable.3 Reducing patient burden has proven to increase retention by 70%. When many studies are failing to meet their recruitment goals, retention is critical. eConsent puts the patient in control of their consenting process. Empowering patients to make informed decisions increase patient motivation to remain in the study. In addition to patient empowerment, eConsent also allows for rich multi-media, proven to increase patient comprehension. 3 Regulatory Compliance At Medrio, we offer flexible configuration making the switch from paper to eConsent easy to manage on the backend, while offering benefits to patients on the front end. Our solution enables you to instantly propagate the latest version of compliance documents across all sites. In addition to videos and graphics, Medrio eConsent gives you the option of using FAQ documentation and quizzes to ensure patient understanding. Our eConsent solution is safe and secure and meets or exceeds IRB guidelines for the consent process. From ICH/GCP and 21 CFR to GDPR and HIPAA, we give you the tools to focus on the trial and the peace of mind that your data is compliant. With decentralized clinical trials on the rise, now is the time to re-evaluate your consenting process. References: 1. Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process. Dresden GM, Levitt MA Acad Emerg Med. 2001 Mar; 8(3):246-52. 2. Readability and Comprehensibility of Informed Consent Forms for Clinical Trials Dr Anvita Pandiya Perspect Clin Res. 2010 Jul-Sep; 1(3): 98–100. 3. The Use of Multimedia in the Informed Consent Process Holly B. Jimison, PhD, Paul P. Sher, MD, Yvonne LeVernois, RN, MS, MPA J Am Med Inform Assoc. 1998 May-Jun; 5(3): 245–256.

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