Does your CRO or sponsor have a policy around IP numbering in clinical trials? If not, they could be putting your clinical trial at risk.
Smart IP Packaging Helps Clinical Trials Avoid Supply Chain Hurdles to Study Startup Ian Davison, Ph.D. Neuroscience, Medrio’s In-house RTSM Subject Matter Expert Packaging decisions may seem benign, but they can have a direct impact on whether a clinical trial experiences supply chain issues. The ability to get investigational products to sites, and appropriately store them, is not a given – and this oversight can have serious consequences. Employing your randomization software for clinical trials vendors’ expertise early prevents these issues from becoming problems and can expose surprising efficiencies. Facing a myriad of deadlines and deliverables, time- and resource-crunched study leaders maintain a delicate balance around how tasks should be prioritized, day-by-day or minute-by-minute, in the race against the clock to FPI (first participant in). Often this means that critical decisions about the core technologies that will enable the study are deferred until just months (or even weeks) before FPI, and why not? Past practice has shown that with the right vendor, the Randomization and Trial Supply Management (RTSM) system can be refined until days before go-live. But this approach is short-sighted. Triaging other decisions and projects over RTSM activities may seem obvious since it enables the study team to prioritize milestones that require a longer-lead time. In fact, often the product is already packaged, labeled, and sitting in the warehouse by the time the RTSM software decision is made. However, when it comes to RTSM software, there are multiple advantages to engaging a vendor up to a year in advance of study start to ensure that the supply chain and clinical operations are operating in tandem. Packaging and labeling decisions made in advance of platform selection may have inadvertently “designed out” critical opportunities to enhance supply management, clinical operations, and participant safety, to say nothing of basic efficiencies. When leveraged early, the right RTSM vendor can answer several critical IP packaging decisions and streamline clinical trial startup. How are the kits packaged and labeled? Some studies will create a participant pack for the participant’s full participation in the study. For example, if the participant is scheduled to complete 10 visits to the site during the trial, the participant pack is produced with enough product for the full 10 visits and, potentially, labeled with the participant’s unique identification number. As each visit occurs, the site takes a kit from that participant’s participant pack. At the surface, this intuitively seems like an efficient and organized way to manage the supply inventory, but consider what happens if that participant withdraws or is removed from the study after two of the 10 visits. Suddenly the site is holding eight wasted kits because they are in a box that is already dedicated to that participant. Similarly, what if – despite best intentions and care – a kit becomes damaged during the study, leaving that participant without a full cycle? In this instance, the easy decision may be to open another box to take a replacement kit, but suddenly 20 kits are tied to one participant because one kit was broken. Consider the financial implications of this waste. If the product cost is $1,000 per participant pack and there are 10 kits in the box, there’s $10,000 sitting in a box, with limited visibility into what has happened to it. How many kits can fit in a box? The question of how many kits can fit in a box is an important metric. Consider this: what if you only fit eight in a box but set the shipment at nine? This means you’ll need to split the kits into two boxes and have all the inefficiencies associated with tracking two shippers and two temperature logs. And be careful – which kits are in with which temperature logger? Experienced RTSM vendors have the foresight to consider these types of scenarios and can work with you to create harmonized kit and shipment designs. This ultimately reduces not only the cost of shipping but the associated environmental and sustainability impacts as well. How many kits can the site store safely? It’s also important to consider not only how many products can fit in a box but the size of the box. Sites and pharmacies nearly always have limitations on the space they can dedicate to kits. For example, you may be able to put one hundred blister packs of paracetamol (acetaminophen) on a shelf. However, if your products are the size of a shoebox, most pharmacies won’t have the space to hold the same inventory of one hundred. The concern around site storage capacity becomes even greater for products that need to be held at an ultra-low temperature or for controlled substances with security concerns, like opioids. With space at a premium, sites need to consider how much space they have in their -80 freezer. Most sites don’t have the capacity to hold one hundred kits in storage. Additionally, many pharmacies have regulations limiting opioid quantities because of the risk of having a controlled substance in a pharmacy, such as theft. How can I make the best use of my limited IP resources? Eventually, kits that have been packaged, labeled, and stored will need to be distributed to study participants. This provides yet another opportunity for sponsors to enhance trial supply management efficiencies by partnering with the right RTSM vendor. Based on the chosen packaging design, an RTSM can be used to build allocation rules and automate the process of distributing kits based on parameters set by the user. For example, the user may choose to manage supply using a reorder-point method, demand drive, or just-in-time strategy. There may be different sources at different stages in the trial (from pharmacy at visit one, then direct-to-participant subsequently). All of these can be supported by the RTSM, ensuring that the correct IP is always available when and where it’s needed and that there are no missed participant visits or other disruptions to study continuity. Realizing the benefits of fully-optimized RTSM While most studies employ some kind of RTSM solution,
It’s 2022—the world is embracing digitalization on a mass scale, yet 76% of healthcare organizations admit to printing their consent forms on paper. Why does the clinical trials industry continue to think that paper forms are sufficiently safe and equipped to handle their patients’ most sensitive data? The Real Cost of Paper in Your Trials Tracking the true cost of paper in your trials can be a difficult feat. Despite the advancements of clinical trial technology and growing guidance / acceptance from regulators for collecting electronic clinical data, a surprising amount of paper continues to exist (and it’s costing you more than just financially). The money and resources spent on storing and archiving paper documents, along with the cost of printing and mailing CRFs (case report forms), is not only expensive, but also a time suck. When using paper to collect data, you’re creating a margin of error that doesn’t need to exist. The time and money used to correct those errors—such as misread handwritten data and the need for double data entry—are easy to avoid. Not only is paper costing you time and money, it’s costing you patients. Consent forms are notoriously difficult and confusing for patients to navigate. The confusion from consent forms alone causes almost 30% of patients to opt out of clinical trials, costing you and your sponsors money. When a patient withdraws from a study, not only does it cost the sponsor three times as much to recruit a new patient, it also costs them the time to enroll new patients and the time invested in those lost. Paper requires double data entry, tracking of CRFs and queries, in-house data quality assurances, and management of the paper itself. Imagine the time and money saved by digitizing the process. That means fewer site visits, resulting in less time and money spent on travel. Switching to an eClinical solution relieves your data management team of the tedious tasks of managing paper and gives them the time to do their job more efficiently. Making the transition from paper to digital can be intimidating. But when you look at what paper is costing you; time, money, and patients, the solution becomes clear: it’s time to embrace digital. Also Read: ePRO vs Paper Strategies in Clinical Trials The Impact of Replacing Paper Processes Speed When you integrate digital solutions into your trial, you can expect to save time. Using a digital solution, like electronic patient-reported outcomes (ePRO), eliminates the human error of paper diaries and removes the need for manual data validation. Patients are encouraged to enter their data directly into a web-based portal — accessible on their preferred device — in an on or offline setting and have that information automatically provided to their study team. When it’s time to submit their information, a reminder or trigger form alerts the patient to make sure they don’t miss an entry. Sites are then quickly notified of adverse events or missing data, enabling a swifter response and minimizing the possibility of trial delays or data errors. This translates to more accurate, trusted data that sites, sponsors, and CROs can use to proactively manage their trial timelines. Scalability As of 2021, McKinsey still estimated that 70% of clinical trial participants lived more than 2 hours from the nearest trial site.1 Trials that rely heavily on paper-based processes are limiting their long-term scalability because they are reinforcing the geographic barriers that preclude patients from clinical research. Considering that oncology and rare disease trials are the largest growing therapeutic area2 for clinical research, it’s especially important to remove geographic, physical, and financial barriers that these patient populations are especially prone to experiencing. Electronic consent (eConsent), ePRO, telehealth are helping sites replace paper processes to reach wider and more diverse patient populations and scale their studies for success. Standardizing workflows also helps increase consistency across teams and sites so your processes can scale with your needs. Flexibility In some cases, paper is simply unavailable. Certain patient populations — like elderly or lower socioeconomic classes — lack access or skill to maneuver electronic workflows. With flexible eConsent and ePRO solutions, teams can streamline electronic data collection using their connected eClinical suite, but also support offline data entry and paper consent forms with ease. Instead of choosing one strict method of data collection, find a solution with the capacity and flexibility to support both. Enhance Compliance Going digital allows you to protect your patients personal information with encryption and permissions that meet the global compliance regulations. Due to COVID-19, the FDA and European Medicines Agency were pushed to clarify their guidelines surrounding telemedicine, creating a clearer path for sponsors than there previously had been.3 Staying on top of regulatory changes can be a burden, but with a digital solution that continually performs in depth analysis of regulations around the world and ensures that their solutions are compliant, you can trust that your data is compliant. Patients also find comfort in knowing that your digital solutions are consistently updated to comply with regulations and it saves you time and money.4 Reduce and Replace Paper Using the Right eClinical Solutions Despite living in the digital age, there is still a need for paper. But clinical teams should be looking to reduce their paper processes and embrace digital solutions wherever possible. The transition from paper to digital can be overwhelming, but Medrio is here to help. Not only do we have the experience and proven results, we can meet you at the level of digitization that’s right for you. References
It’s 2022—over one hundred years have passed since the women’s suffrage movement; women make up more than half of the college-educated workforce; and the U.S. has our first female Vice President. But, many of us continue to ask, “Is that enough?” (Hint: the answer is a resounding NO!)
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.
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,
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:
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.
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:
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
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
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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