The Pandemic Changed Clinical Trials for Good
(Thursday, August 19, 2021)
Two-thirds of the sponsors of clinical trials intend to continue remote clinical trials post-pandemic. Trials that are entirely run using electronic documentation, digital communications, and remote monitoring cost more than conventional studies due to the initial investment in technology acquisition, but the increased cost was off-set last year by reduced travel and conference costs, and other expense reductions. Most sponsors found running a trial remotely to be challenging mostly due to need to learn to collaborate using remote tools, lack of productivity tools, limitation in conducting due diligence remotely, and maintaining digital documentation. These were the key findings of an independent survey of clinical trial sponsors primarily located in US, Canada and Europe. Last 12 months saw an explosion of remote clinical trials as sponsors tried to re-start trials suspended by the pandemic. Remote clinical trials are trials where all communications between sponsors, investigators and patients are digital, there are fewer patient visits to clinics, data is collected and monitored using remote tools, and all documentation is digital. However, the expedited schedule for the transition from conventional operations to digital procedures was harder than expected for trial teams. Seemingly, most sponsors did not anticipate the increased cost of technology acquisition which includes not just licensing or buying a tool but implementing it in a quality system. For a trial that was originally planned to be conducted using conventional tools, resources that had been already allocated for planned tasks had to be repurposed for the remote processes. This included re-writing of project plans, training, implementation, and quality control, which could explain the increased initial cost for remote clinical operations. However, most of the tools and practices that were developed for the special circumstances can now be used for future trials. Hence, it would be reasonable to expect that the sponsors will continue doing remote clinical trials even when it is not critically needed post-pandemic. Key highlights for future growth are training in running remote clinical trials for all study personnel, technology products that are easier to implement and cost less for implementation so can be widely adopted, and improved methods for identifying and communicating with healthcare professionals and patient populations. Most of these challenges for running remote clinical trials seem expected issues with any large transition between core systems. As sponsors, CROs, physician investigators, and patients get used to remote procedures, these processes can be repeat for all future trials, as it should be.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC