Clinical Development rapidly advanced this past decade. New endpoints and measures covering genomics and devices emerged. New design methodologies like adaptive trials and basket trials gained acceptance. And new advances in clinical operations in areas like risk based monitoring improved safety and efficacy.
In spite of substantial progress, several challenges remain. Today patient access and patient retention persist as the costliest and most time consuming challenges our industry faces. We’re all familiar with the statistics and persistent challenges they underscore. A relatively recent analysis of ClinicalTrials.gov data, “Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination” underscores the challenges surrounding patient participation in clinical trials:
The analysis finds that of the studies that were terminated in the ClinicalTrials.gov database, 68% were done so due to reasons other than data accrual, and of that cohort, 57% were terminated due to an insufficient rate of accrual.
Patient enrollment and retention continue to challenge our industry, and that was prior to our global pandemic. And with precision medicine leading to ever narrower treatments and patient populations, these twin challenges will likely persist.
Improving on these challenges will require a rethink across the clinical development continuum that prioritizes patient experience at every step in the process. Ultimately the sponsors and CRO's that prioritize the patient's experience throughout the clinical development lifecycle will benefit from faster FPI to LPO cycles and a higher proportion of studies with sufficient data accrual to complete the study.
What will putting the patient at the center of the clindev experience look like?
If you ask me, it looks a lot like Medable's Patient, Site, and Sponsor apps.
Each has been developed in close partnership with some of the leading patient advocates, doctors, researchers, and clinicians across clinical development. And with every standardized offering or workflow, Medable has stopped to ask the question, "Does this enhance or hinder the patient (and clinician) experience?"
The result is a fundamentally new approach to clinical development, one that utilizes best practices from Medable’s deep learnings in hybrid and decentralized clinical trials (DCT's). These learnings are then complemented by a commitment to delivering the same consumer-grade experience that delights patients and clinicians when they use their favorite apps like Netflix or AirBnB.
In practice this means that we strive to allow sponsors and CRO’s to right-size their journey to DCT’s by offering a Readiness Framework that clearly shows the progression from light-weight TeleVisit and TeleConsent capabilities to capturing digital endpoints via COA’s, PRO’s, and other forms of digital source data.
At Medable we recognize that each study is unique. Each covers a different treatment and operates in a unique combination of phase, therapeutic area, regulatory environment, and much more. That means that every Decentralized Clinical Trial (DCT) must fit the unique needs of the patients, investigators, clinical, and regulatory professionals and ensure clinical trials continue to deliver the quality our patients deserve and regulators require.
That’s why I’m so excited to be part of a team of diverse clinical leaders who have the experience, perspective, and passion to help the clinical development process to evolve in a meaningfully positive way. And it starts with our CEO Michelle Longmire, a true visionary who leads by example and is steadfastly committed to ensuring we succeed as a team.
Getting the chance to shape a fundamentally new approach to something as important as drug discovery and commercialization is quite rare. And for that I am grateful to be part of an amazing company that is laser focused on solving the twin challenges of patient access and recruitment. It’s why I joined Medable.
If you'd like to join Medable and help shape the future of the growing DCT movement, we invite you to join us. We are hiring (or will be soon) in just about every department and every geography. I’m looking for strong marketers in product marketing, demand gen/growth, brand/creative, and more. Feel free to apply at www.medable.com/careers.