Jul 26, 2024
Abstract
COVID-19 appears to have been the catalyst required to overcome prior reluctance to embrace decentralized trials. In March, the FDA issued guidance recommending the use of virtual visits and virtual assessments in ongoing trials whenever feasible [1]. It also allowed for these changes to be implemented immediately, prior to formal IRB approval, further incentivizing the implementation of this model. Decentralized trials were uniquely positioned to accommodate these changes as they leverage telemedicine and other innovative methods of remote data collection, avoiding the need for trial participants to travel to study locations.
Current Trends
Many of the tools required to successfully implement decentralized trials were already in place prior to COVID-19 and were slowly being incorporated into clinical trials over the last decade [2]. With recent events, it stands to reason that this trend will only accelerate. However, these tools are often scattered across multiple entities in the form of programs that required integration by a CRO. The leap to a full-feature digital clinical trial platform is quite large and not realistic for most platforms. This has created a need for alliances among digital servicers to meet demand. Companies that were missing some of these features quickly developed them or formed partnerships with those that could provide them. For example, CTI Clinical Trial and Consulting, a major CRO, partnered with Medidata, a software company that enabled them to monitor several trials remotely [4]. Like many major industries of the past, it appears the fragmented digital health space is headed toward increasing consolidation in the coming years.
Implications for Clinical & Market Access Teams
As CROs form additional partnerships, they will be able to offer a more robust range of digital services for their biopharmaceutical clients, each of which has unique advantages. Those that can offer online patient recruitment promote broad geographic participation which can potentially lead to faster recruitment times as well as increased diversity among participants, improving the generalizability of study results [5]. Others that allow for a single team to perform remote assessments across multiple trial sites, like the CTI-Medidata partnership, may lead to reduced variability in data. Ultimately, a strategic partnership that can reduce the number of physical research sites requires fewer institutional review boards, and therefore lowers regulatory and monitoring costs.6 As such, the ability to operate digitally should be a major consideration when choosing a CRO to facilitate future trials.
US Payers desire both scientific rigor in clinical trial design and real-world applicability of trial results. Common elements of such trials include clinically effective comparators, study patients with common comorbid conditions, and diverse demographic characteristics, and providers from community settings. Payer responses to decentralized trials have been positive thus far. In the future it’s likely that best practices in decentralized trials will center around the following areas:
- Triangulating evidence of effectiveness from real-world settings with data from regulatory RCTs and internal claims data sets
- Improved data on health outcomes for patients who more closely reflect the diversity of patients they enroll, as well as meaningful data on subpopulations for which a drug works
Organizations seeking to better understand how to execute decentralized clinical trials in a digitally driven climate, should align towards payer anticipated needs and emergent opportunities in data collection and reporting.
Contributors
Olivier Jarray is a Subject Matter Expert at Princeton Biopartners. He brings a wealth of experience in global life sciences, consumer health and digital health. He has designed and implemented new business models to improve access to medicines and led corporate strategy and M&A at Novartis and Bayer, globally, as well as at BMS, regionally. He holds an Executive MBA from NYU Stern, HEC Paris, and the London School of Economics.
Mary Nattakom is a Research Analyst at Princeton Biopartners. Her experience includes research in tissue stem cell biology and work experience on a hospital’s digital health team. Mary received her B.A. in Biological Sciences and Chemistry from Cornell University and is a MD Candidate at Columbia University, College of Physicians and Surgeons.
References
1. Center for Drug Evaluation and Research. (2020, March). Guidance for Industry, Investigators, and Institutional Review Boards. Retrieved September 11, 2020, from www.fda.gov
2. Chen, Connie E., et al. “Characteristics of digital health studies registered in ClinicalTrials. gov.” JAMA internal medicine 179.6 (2019): 838–840.
3. IQVIA Alliance. (n.d.). Retrieved September 11, 2020, from https://www.obviohealth.com/iqvia-alliance/
4. Drucker, C., Oestreicher, P., & Connaughton, A. S. (2020, July 8). Medidata Partners With CTI for Remote Source Review of Clinical Trials in Response to COVID-19. Business Wire. https://www.businesswire.com/news/home/20200708005231/en/Medidata-Partners-CTI-Remote-Source-Review-Clinical
5. Dorsey, E. R., Kluger, B., & Lipset, C. H. (2020). The New Normal in Clinical Trials: Decentralized Studies. Annals of Neurology. doi:10.1002/ana.25892
6. Clinical Trials Transformation Initiative. Decentralized Clinical Trials. 2018. https://www.ctti-clinicaltrials.org/projects/decentralized-clinical-trials. Accessed September 16.