Panel recap: “Trial continuity during COVID-19”
COVID-19 is dramatically impacting clinical research, leading to questions about the most effective solutions across the industry. On Thursday, April 16th, ERT hosted an interactive webinar with experts who discussed clinical trial continuity during the COVID-19 pandemic. This “Trial Better Live” briefing featured:
- Ken Faulkner, PhD, Vice President of eCOA Science and Consulting, ERT
- Jim Munz, Vice President, eCOA Product Management, ERT
- Kenneth Kaitin, PhD Professor of Medicine and Public Health and Director of the Tufts Center for the Study of Drug Development, Tufts University
- Laurent Schockmel, MBA, CEO, Antidote
Current trends and future challenges for clinical research
By addressing the key questions listed below, the panelists aimed to surface insights and provide confidence that research can and will continue to move forward:
- What are the biggest challenges of endpoint data collection facing clinical trial sponsors during COVID-19?
- How can sponsors and service or technology providers collaborate to achieve clinical development goals?
- What is this pandemic teaching us about the industry’s dependence on patient access to investigative sites?
- How can sponsors prepare for virtual trials during (and after) COVID-19?
To ground the discussion, Ken Kaitin provided statistics around current trends and future challenges for clinical trials:
- Drug development timelines vary across therapeutic areas, ranging from approximately 6 to 10 years.
- Overall clinical approval success rates for new drugs has dropped to 11.8%, and capitalized R&D costs have increased 145% since the early 2000s.
- Looking at trends in protocol complexity (2001-2005 vs. 2011-2015), the total number of endpoints, eligibility criteria, procedures, procedures per visit, and data points collected has increased significantly.
Setting the stage for the panel discussion, Ken Kaitin stated that we must embrace protocol optimization initiatives like planning for pre-approved design changes and increasing the use of technology to reduce patient burden, boost retention, and lower costs.
COVID-19’s impact on research
Antidote’s CEO, Laurent Schockmel, broke down some of the ways that Antidote is working with sponsors to help them shift gears to try to stay on course or to minimize impact. He also explained how Antidote is engaging patients around COVID-19 research. Key takeaways include:
- In terms of sponsors, Antidote has seen:
- Interest in pre-recruitment tactics so trials are ready to hit the ground running when things get back to normal
- An influx of COVID-19 studies looking for patients to take part
- Variety in how sponsors are handling pausing recruitment — some are swapping sites or countries to move away from virus hotspots, while others are pausing for a definite amount of time
- In terms of patients, Antidote has seen:
- Higher rates of phone availability and more patient callbacks
- Few indications that patients are uncomfortable with participating at this time
- Increased patient engagement with advertising online
Earlier this week, Antidote officially added COVID-19 to our clinical trial search platform. Doctors and patients can visit our search tool to answer a few questions to help them match to a trial. Many of our partners are also offering some excellent resources about COVID trials.