Running Safe and Effective Clinical Trials Post-Pandemic

The pandemic has brought many changes to the way that we live our lives.   One question that remains; how will the pandemic impact a post-pandemic world?   We are already seeing evidence that many workers who moved from an office environment to a work-from-home situation may stay at home for all or part of their workweek.   Many changes that we thought unthinkable in the past have now become much more commonplace as we learned to adapt and cope as a result of the pandemic, particularly in the clinical trial space.

Slower Clinical Trial Participation During the Pandemic

During the pandemic, many sponsor companies realized that participants in clinical trials were reluctant to attend in-clinic research visits for fear of exposure to Covid-19.    In response, they quickly amended protocols and visit requirements to make “televisits” possible as well as working with sites to conduct at-home visits instead of in-clinic visits.   At-home nursing companies were quickly trained on protocols so that they could conduct important study visits and gather important information such as blood samples and vital signs in the subject’s home.   This was all in reaction to the pandemic.

Growth in Virtual Clinical Trials

What we are seeing now, as we approach an end to the pandemic, is a proactive approach to making clinical trials easier for those subjects that wish to participate, but not in person.  New trials have more phone calls to gather study data instead of in-person clinic visits.   At-home agencies are being discussed at the study start so that sponsors can be ready and not lose any valuable data as part of their study plan.   Sponsor companies are also adapting the way that they check on the data coming from the site with remote monitoring plans taking precedence over on-site visits to review data.

We are seeing a change in how trials will be run as a result of the pandemic.   I am not sure if this will be the push that the industry has been considering for years to conduct more “virtual trials” to obtain study data, but it is clear changes are being made to get us closer to that goal.    I think in the short term there will still be a need for in-person study visits, but clearly, there is a shift in how many visits will be conducted on-site and contingency plans will be considered for times when on-site visits may be problematic.

The pandemic has changed virtually every aspect of our lives.   It is only natural that we see some changes in how clinical trials are run.   What remains to be seen is how many changes are made and how long these changes remain in place post-pandemic.