Trial Innovation Beyond the COVID-19 Pandemic

Lisa Henderson

As of Sept. 1, 2020, ClinicalTrials.gov lists 284 clinical trials as suspended. Not all of those trials are suspended for COVID-19, some are holdovers on financial issues, R&D problems, etc. And while upwards of 1,200 trials were suspended at the peak, according to GlobalData, 67% of healthcare experts plan to use decentralized clinical trials in the near future due to COVID-19. To address the walk back to clinical trials, Applied Clinical Trials is planning a virtual event mid-November that will highlight the successes that clinical trials experienced during this time, and open dialogue for the continued innovation within the industry.

Solutions to enhance patient participation

According to press releases and reports of the time, solutions to ensure that participants could continue to stay in clinical trials safely were on the rise. In this article from our June issue, we noted that the “newer methods” of patient-centric clinical trials trend toward home study visits, telemedicine, and remote patient monitoring, have been happening over the past few years, but uptake was slow. We know the numbers for low patient enrollment: Tufts Center for the Study of Drug Development found no significant differences in the mean number of patients enrolled per site or by therapeutic area in 2019 versus 2012. The study also showed that late-development studies had a higher average drop-out rate in 2019 (19.1%) than in 2012 (15.3%).

During the pandemic, service providers offering safe patient access and decentralized model enablement, found increased interest in their business. Darcy Forman, vice president of clinical operations for Science 37, a provider of virtual clinical trials, commented at the time, “We have been unbelievably busy with this pandemic as sponsors are wanting to transition to a virtual model. It’s really accelerating, and they are finally pushing through their hesitancy.” Science 37 recently partnered with ERT to implement their cardiac safety, respiratory, and imaging solutions to capture data from participants in decentralized trials.

In this interview, Michelle Longmire, MD, co-founder and CEO of Medable, reported increased business across the board. She said, “…everyone from existing partners to totally new partners were calling us around the clock looking for help. We created a workstream for rapid validation and qualification of individual studies, as well as partners, so that we could deploy technology quickly. What was never thought possible before was suddenly turned around in a matter of days to a week. We literally turned months-long timelines into days—and this was key, as was the ability to deploy technologies with necessary processes around patient data privacy, security, and data quality.”

That sense of urgency and can-do attitude is what our event will highlight. We are currently recruiting speakers to share their experiences in the following topic areas: the patient participation piece; the New Clinical Trial and how sites and sponsors transitioned to address the barriers of COVID; and Ensuring Data Quality and eSource Implementation—again another “old is new again” strategy to gain forward momentum in the clinical trial discourse. We look forward to sharing your ideas during this forum.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mmhgroup.com. Follow Lisa on Twitter: @trialsonline.