Clinical Trial Blog: Research Insights for Success

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.

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

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

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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Virtual, Decentralized, Hybrid: What’s the Difference?

August 3, 2020

The clinical trial landscape is ever-changing. New technology and innovation have changed the way we look at clinical trial design. While we can agree that the recent focus on patient-centricity has been a long time coming, the industry as a whole has struggled with agreeing on how to shift trial designs to be more patient-centric. There are a lot of confusing terms circulating as they relate to clinical trials — virtual, decentralized, hybrid, remote, siteless — the list goes on and on, but what do they mean from a practical standpoint? Can the industry be expected to switch from a traditional clinical trial model to virtual clinical trials overnight? The answer is this would be wildly impractical, not to mention improbable. The process to move to a more remote or virtual environment takes planning, restructuring, and most of all time. In the wake of COVID-19, we’re learning the impracticalities of making a virtual trial a reality overnight. So what is the solution when faced with a global crisis? Decentralization. You may be thinking that virtual and decentralized are one and the same, but I believe the definitions are a bit more fluid. While the terms virtual and decentralized have been used synonymously, hybrid trials have also been described as a decentralized trial. I view a virtual trial as being siteless and fully remote, meaning no or extremely limited physical contact between clinicians and patients. In this model, patients are utilizing remote eConsent, telehealth, and ePRO/eCOA. Researchers and clinicians are using telehealth to communicate with patients, direct capture to record patient observations, and an Electronic Data Capture (EDC) system to store the data. With a decentralized trial model, I believe there is a bit less rigidity to the definition. I view decentralization as a flexible path. Decentralization is ideal for sponsors and CROs who want to be patient-centric and improve data quality, but aren’t prepared to move to a completely remote model. I like to think of decentralization as a bridge between traditional models and virtual models — a hybrid approach. Decentralization is ideal for transitioning into a virtual environment and while used synonymously with “virtual” nine times out of ten a decentralized trial is what we refer to as a hybrid trial. A hybrid model utilizes any combination of traditional and virtual trial elements. The Medrio Difference We recognize that the variety of terms and the nuanced meanings behind them can be confusing and overwhelming. It’s hard enough adopting new technology, why add confusing terminology into the mix? That’s why we developed our Decentralized Clinical Trials Solution to meet the needs of traditional, hybrid, and virtual trials. Our technology is flexible and adaptable to meet your needs. We also recognize the time and effort involved in the decentralization process. Our professional services team is equipped to provide guidance throughout your process, whether it be moving from paper to electronic data collection or from in-clinic to remote patient engagement. Additionally, our Global Support team is on call 24/7 ready to answer your questions. Medrio’s Support team really goes above and beyond the call of duty, always putting our customers first. But don’t take my word for it, hear what our customers have to say.

Why Are Real-Time Edit Checks Important in Clinical Trials?

July 16, 2020

Modern clinical trials can be sprawling networks of clinics, people, and data. They can span borders and oceans. They utilize various communication channels. And they involve a multitude of interested parties, including patients, researchers, and other staff. In undertaking such complex trials, it can be difficult to provide sufficient oversight to ensure the quality of the most important and fundamental component of clinical research: the data entered. To prevent lapses in data quality, many EDC companies offer edit check functionality, whereby their software recognizes errors and fires queries when they arise. But ensuring data capture quality is only part of the solution; in today’s competitive research environment, in which there’s more pressure than ever for researchers to keep timelines down and stay within budgets, it’s also essential to do so as fast as possible. That’s why the ability to perform real-time edit checks, rather than having to wait until a designated moment to view and address queries, can make or break a study’s chances of success, elevating one of the clinical trials challenges. Indeed, this ability can be hard to come by. Safeguards of data quality in an EDC typically involve an established range of acceptable data for a given data point; the system fires a query when a piece of data falls outside of that range or isn’t entered. But most EDC companies don’t allow access to those queries until after data is submitted. This means that site staff may not recognize data errors on a form until after they’ve completed and saved it. To address the query, users have to reopen the study and backtrack in order to correct the error. They may be forced to consult their source documents again or to scroll through a lengthy form in search of the query. Over the course of the study—especially one involving long and complicated forms—the time this requires can add up. Recognizing the various drawbacks to this system, Medrio allows for real-time edit checks, so that queries fire the moment an erroneous piece of data enters the system. Users can rest assured, as they conduct their research, that no data errors lie waiting to cause headaches once a form is closed. Why Now? Producing sound data has always been important in clinical research, as has the ability to do so with efficiency. But until recent years, achieving these objectives was less of a challenge. The average clinical trial was smaller and more centralized, making it easier to oversee data entry and keeping the chance of error to a manageable level. Today, larger, farther-reaching, and more complex decentralized studies are growing in popularity among sponsors. A typical study now includes numerous sites across numerous countries, as well as large research teams whose members often work remotely from one another. The sheer quantity of data collected in such complex trials can be overwhelming. It also creates a much higher risk of human error during data entry than previous generations of clinical researchers, whose studies were smaller and more centralized, needed to manage. This, combined with recent regulations aimed at ensuring data quality that has arisen as a result, create a market for an EDC feature like real-time edit checks that can guard against data entry errors without allowing them to compound or delay a study. Current market trends make the case for real-time edit checks even more compelling. Not only are trials getting bigger and more complicated, but they’re also getting more competitive, as well. Increased demand for clinical trials has raised the stakes of competition among sponsors, with effects rippling out among CROs, sites, and other involved parties. And as the cost of drug development continues to rise, budget concerns add even more pressure. Researchers today are racing to get their products to the FDA like never before, both to beat the competition to market and to minimize the impact of their studies on their pocketbooks. The time savings created by real-time edit checks make it easier to accomplish these goals. In light of these conditions, clinical research today is ripe for an EDC tool that can not only detect data-entry errors that site staff may have missed but seamlessly integrate that detection into the research process. From increased error risk, new regulatory compliance burdens, and a higher-than-usual premium on efficiency in an already time-sensitive industry, it’s something of a surprise that only a few EDC providers offer such a tool. Medrio’s real-time edit checks functionality is just one of the many features that make the software uniquely simple, intuitive, and, most importantly, well-positioned to help researchers keep data quality up and timelines down in a competitive industry. References:

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What to Keep in Mind When Your eClinical Provider Gets Acquired

June 17, 2020

We comment a lot, on this blog, on the trends influencing the direction of clinical research and the eClinical technology industry. One trend that has become an especially prominent topic of water cooler conversations today is recent acquisitions in the eClinical space. There have been a number of high-profile cases in recent years of technology giants hoping to edge their way into the life science field by acquiring an eClinical software provider. Opinions and reactions abound when it comes to these things. Many will point out the positive effects of such acquisitions: for the acquired company, stock boosts for employees, more stability, and a growth infusion are just some of the benefits people cite. And they’re right to do so. But when the ink dries and the hands are shaken, the customers of those companies – the people on the ground who rely on fast and easy software in their pursuit of life-saving medical breakthroughs – may find themselves in a strange and unfamiliar landscape. All of this raises the important question of how data managers and site staff should react when their provider announces an acquisition. Customers of acquired eClinical providers can take comfort in the validation and stability that such acquisitions bring. But there are certain aspects of recent acquisitions in the eClinical software industry that have some people scratching their heads. 1. The parent company is an outsider In recent cases, the company acquiring an eClinical provider is not, itself, in the eClinical space. This means only a fraction of the parent company’s product development will go toward improving the eClinical platform that users have come to depend upon, leading to a slower and less robust product roadmap, with fewer resources dedicated to ensuring speed and ease of use for eClinical users. 2. Turnover is inevitable An unavoidable byproduct of corporate acquisitions is significant employee turnover. Many of the people who helped build the acquired company and who understand its strengths, weaknesses, and the unique needs of its customers move on, leaving those customers to work with a whole new cast of characters unfamiliar with the nuances of each project. 3. Doing business becomes a chore The bigger a company gets, the harder it can be to connect with support staff who understand and care. Moreover, with acquisitions, customers can find themselves suddenly facing new and more complex pricing structures from the parent company looking to recoup their investment. The bottom line: clinical researchers who are trying to focus on treating disease and saving lives are suddenly mired in financial and logistical headaches. At the end of the day, clinical researchers need an eClinical solution that delivers the ease of use and functionality to get their studies up and running quickly and create a smooth path to database lock. Along the way, they need to know that they won’t get bogged down by unnecessary complexity, out-of-reach support resources, or opaque cost structures. Adding uncertainty and a diminished customer focus only makes the situation worse. After all, lives are at stake – there’s little time to waste on logistics. While the eClinical acquisitions making headlines in recent years do offer some reason for excitement, the customers of acquired companies should consider what the impact could be on their ability to answer the call of public health.

How did Medrio Achieve FPI in Seven Days?

June 8, 2020

“We’re faced with an unprecedented challenge in the time of COVID-19, but our collective determination and expertise enabled us to execute. Detecting sepsis early is imperative for effective treatment and would enable the clinical team to ensure that the right patient receives the right level of care at a time when resources are stretched and every moment counts. Achieving FPI in only seven days is a huge feat, and all parties involved should be extremely proud of their efforts,” said Ajay Shah, Ph.D., Co-founder, and CEO of Cytovale. A typical study with Medirio can get FPI within 6 weeks compared to the industry average of 12 weeks, due to the programming free drag and drop interface of our EDC system. Speed coupled with a flexible system puts you in the driver’s seat allowing changes on your timeline without coding or extra fees. From ICH/GCP and 21 CFR to GDPR and HIPAA, our customers are equipped with easy-to-use tools allowing them to focus on the trial with complete confidence that their data is compliant and secure. As organizations transition to more virtual operations, our hybrid and decentralized solutions are ready to help you meet accelerated timelines and changes when you need them.

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Patient Diversity and eClinical Vendor Selection

March 27, 2020

Regulators and many in the clinical research industry emphasize patient diversity, but how do contract research organizations (CROs) and sponsors achieve it? The US Food and Drug Administration (FDA) recently released its Drug Trials Snapshots for 2019 – a document that shares the demographics of clinical trial participants in approved clinical trials. Here are some key findings: More women are participating in clinical trials. Of drug trials that gained approval last year, 72% of participants were female. Diversity has decreased from 2018. Last year, only 9% of participants were Black or African American, 9% were Asian, and 18% were Latino. While these demographics shift from year to year, patient diversity is a critical is a growing trend and crucial aspect of successful research. To adequately prepare for the future and to best serve populations in need, we encourage you to consider this during eClinical vendor selection. Let’s take a deep dive into patient diversity’s significance, main obstacles, and see what eClinical features can help: Why is Patient Diversity Important? For study results to show safety and efficacy for all people, participant demographics need to mirror the country’s population. For example, when the US FDA approves a treatment, it can be prescribed to people of all ages, genders, races, and ethnicities. Some diseases, however, disproportionately affect specific demographics. There is also growing evidence that drugs have different effects on different populations. With the rise of personalized medicine, one-size-fits-all medicine is becoming a thing of the past. On top of this, more effective treatments for all communities means more safety and overall better public health. Regulators are also starting to demand it. In 2015, the FDA began publishing the demographics of clinical trials for newly approved drugs. Although the organization can’t set official guidelines for age, gender, and racial representation, they have called out the lack of diversity. Enrollment should reflect the patients most likely to use a medical product. Therefore, better diversity can improve your treatment’s chances of regulatory approval. Why Is There Such a Big Clinical Trial Participation Gap? One of the main reasons is the fact that many are unaware that clinical trials exist. Even though many organizations are harnessing new technology to increase awareness, connecting participants to trials is a great challenge. Then, there are logistical and financial challenges. Data shows that people making less than $50,000 per year are significantly less likely to participate in clinical trials. Traditional clinical trials often require participants to take time off off work, commute long distances to sites, and find childcare. This means that those in rural areas or with lower incomes will likely not consider joining a traditional study. Distrust of the health care system and clinical trials also exists for some groups. Because clinical trials are inherently risky, building trust with the target demographic of your study is essential to research success. What Can Improve Patient Diversity In Clinical Trials? Improving awareness is a fundamental way to help boost patient diversity. Research shows that patients are more likely to enroll in trials if their health care provider recommends it. Many have also turned to social media to get the word out. From an eClinical perspective, decentralized clinical trial capabilities can greatly expand inclusivity – and you don’t have to go entirely virtual to accomplish this. Reliable tools like ePRO can reduce patient burden by allowing participants to provide patient-reported outcomes from home. Participants will spend less time traveling to sites and avoid needing childcare or time off work. eConsent can also help in efforts to boost trust and engagement. Although this tool is relatively new, it’s proven tremendously useful in increasing patient comprehension and patient retention. Lastly, even in developed countries, the internet can be spotty when outside of urban areas. Having Direct Data Capture (DDC) that can collect data offline and sync directly with the EDC once connectivity can expand your data-capture capabilities and give you more flexibility. The benefits of boosting patient diversity are huge: more people will benefit from your discoveries. Also, your results will be more representative and relevant to all segments of the population. For us at Medrio, we’ll continue doing our part to support patient diversity in clinical research with our EDC and eSource suite. By increasing access to clinical trials for all, we can have a more substantial impact on public health and health equity.

eClinical Customer Service

March 11, 2020

With so much riding on the outcome of your research, you want to have reliable eClinical customer service behind you. When evaluating eClinical service providers, customer support may not be the first thing to come in mind. You may be more focused on the essential features you need to suit your study. However, beyond the careful evaluation of the functionality you need, it’s wise to consider the people behind your software. No matter the type of research you conduct, you want smooth trials. Proactive training and quick problem resolution can help you meet this goal. One of our Customer Success Managers, Lisa Charlton, sums up Medrio’s view of customer success in a recent interview: “Customer success is good data with minimal pain points. No clinical trial will be without problems, so a responsive support system with proactive training is essential to a successful model whether you’re a site, sponsor, or CRO.” We’re proud to have supported more than 4,500 studies and have a 98% satisfaction rating. As clinical trials grow worldwide, and more eClinical services emerge, it can be challenging to select best-fit solutions. Let’s look at several things you should look for from a customer service perspective: Proactive eClinical Customer Service is Best “I strive to form strong, collaborative partnerships. I ensure customers take full advantage of our software and utilize it in the best way possible to achieve their business objectives. Also, one of my most important responsibilities is to serve as a customer advocate — making sure their voices are heard.” — Laurin Willetts, Medrio Customer Success Manager Just like the old saying, “An ounce of prevention is worth a pound of cure,” you want service that takes preventative action. For example, one of our clients recently faced a tough challenge: they had to go live less than two weeks after new software implementation. They had scheduled in-person training in Perth, Australia; however, they were also able to begin training immediately via WebEx to transition smoothly despite the time crunch. Also, there’s nothing worse than getting a piece of technology, having problems, and then waiting for customer support. Once you’re up and running, you want to move forward knowing your detail-oriented customer support team will be available 24/7 to resolve any issues quickly. Success Story: Advance Research Associates Finds a Strong eClinical Partner in Medrio Customer Success Managers with Industry Experience is a Huge Plus Having customer support managers who’ve walked in your shoes can add tremendous value. Check to see if your eClinical service provider’s team has staff who’ve worked in the industry and have in-depth regulatory knowledge. Their firsthand insights into your challenges and obstacles can go far beyond average support. We’re proud to have several Customer Success Managers on staff with extensive backgrounds in clinical research. Our Customer Success Manager, Lisa Charlton, holds a Ph.D. in Biology and consulted on clinical outcome assessments and eCOA implementation. When we sat down with her recently, she told us, “I think the eClinical companies that will be most successful are the ones that address the personas of the site, data manager, and patient in a timely and cost-effective manner. She adds, “I learned firsthand from sponsors about obstacles at their sites — a central focus of my career has been understanding customers and helping to solve their problems.” In another recent interview, we sat down with Laurin Willets, a customer success manager who shares her personal experience using Medrio in clinical trials. Managers like these can help you with highly detailed questions that save you time and frustration when working through your trial. Make Sure They Can Take Compliance Concerns Off Your Plate With global regulations — from Asia to Europe to North America — rapidly shifting and becoming more strict, there’s a lot to keep in mind when it comes to compliance. Be sure to check that your software is prepared for all major upcoming regulatory shifts, like MDR. But beyond the software, make sure your customer support team can answer specific questions you might have about compliance. This team should inform you of approaching regulatory changes, and the software should do the work for you without you having to worry. For example, our eClinical suite is ready for any changes to global compliance well before any changes go into effect. It’s Helpful to Have a Unified Support Team Many eClinical service providers offer a variety of tools. For example, we provide EDC, direct data capture (DDC), ePRO, and eConsent software. Check that your customer support team has been trained on all tools. It’s much simpler to deal with one team for all services, instead of having disparate support teams for each tool. For example, all our customer success staff are trained on all software. You can go to one place for all your questions throughout your study. Many other eClinical support providers have different teams for different tools due to their size or because of acquisitions. This means you would have to talk to various support teams, and no one person could help facilitate your trial from end to end. Customer service shouldn’t be overlooked when deciding on an eClinical service provider. Part of having safe and reliable software is a knowledgeable and proactive team behind it to facilitate your productivity. For us at Medrio, we’re proud to have industry-leading customer support. We will continue doing our part to provide researchers with the tools to continue making breakthroughs in public health. Your success is not only ours but also the patients who need your work.

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5 Considerations When Choosing an eClinical Platform

September 11, 2019

Digital technology is now completely intertwined with our lives. It’s transformed the way we communicate personally and professionally and has revolutionized industries from business to banking to transportation. The clinical research industry may have been cautious about going digital, but researchers need to be aware that new tech, such as an eClinical platform, will play a more significant role in the future: With this shift, new Electronic Data Capture (EDC) and Direct Data Capture (DDC) solutions have emerged to support and facilitate research. This variety has many positives and provides more assurance that researchers will get their needs met. Still, too much choice can also potentially confuse and complicate the selection process. Since lives are often at stake when it comes to clinical research, best-fit solutions are a must. Take a look at 5 essential considerations when choosing an eClinical platform: 1. Data Quality It’s crucial to learn how a platform ensures data accuracy. Clean data is the foundation of clinical research, and data problems can hinder the path to regulatory approval. Medrio’s EDC, for example, has form rules like edit checks and skip logic to help ensure rapid and precise data entry. Data is then instantly available for review, analysis, and collaboration with Contract Research Organization (CRO) and site partners. Additionally, Medrio DDC, an eSource solution, has shown to reduce transcription errors by 90%. 2. Regulatory Compliance Check how an eClinical service facilitates compliance. In recent years, global clinical trial regulations have undergone tremendous change — and more is on the horizon. Quality solutions should take compliance concerns off researchers’ plates, so they have full peace of mind as they move towards their goals. For Medrio, the software directly integrates global compliance. Additionally, a dedicated team stays on top of upcoming shifts and updates the platform well before any new regulations go into effect. 3. Flexibility and Adaptability Control and independence are also essential considerations. Legacy eClinical services often deliver sophisticated solutions that require external support, which can lead to protracted study builds and time-consuming delays. Consider if this type of solution is necessary since research teams can often manage trials easily and independently. We recently sat down with one of our customer success managers who also worked in clinical operations for 15 years. She shared her personal experiences using Medrio and another large EDC and described how, with Medrio, she was able to build and manage studies without outside programming support. Also, during the research process, unexpected obstacles can arise, and researchers need to adapt quickly to stay on a timeline and budget. Check how a service can support you when the unexpected happens. For Medrio, we provide several APIs that can help organizations quickly expand their eClinical capabilities to integrate external platforms if necessary. 4. Customer Support and Training Evaluate the support team. If any snags come along during research, you want to be sure you’re in good hands. Check if they have industry experience and regulatory knowledge. Can they understand and empathize with your challenges? How responsive is the team, and how intuitive is the software? For Medrio, many customer support managers have industry experience. 91% of support cases submitted to Medrio’s headquarters receive responses in 10 minutes or less — no matter what time or day of the week. Also, robust eLearning ensures that users get up and running in no time. 5. Is It Reliable? Finally, it’s vital to look into the track record of an eClinical service provider. How have other researchers leveraged this software for success? How long has the organization been around? Do they have experience working with similar types of research? Medrio has been around for 15 years and has been used in 4,500+ studies with 600+ customers with a 98% customer satisfaction rating. While many eClinical service providers have been affected by recent acquisitions, we stay independent, in control, and entirely focused on customers’ needs. Success Story: Medical Device Company RefleXion Counts on Medrio to Launch First Studies New technology is only going further integrate with clinical trials. And while adapting to the evolving clinical research landscape may come with growing pains, there is vast potential to improve public health in ways that, until recently, seemed out of reach. Choosing an eClinical platform can be a challenging process. Still, focusing on the right questions and finding best-fit solutions can save vast amounts of resources down the road — and better serve populations in need.

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