Clinical Trial Development During the Pandemic: How Do We Measure the Effects?

There is much focus on the clinical trials for COVID-19 treatments and vaccines, but current and future clinical trial programs need attention as well. Like every other facet of the healthcare industry, they have been uprooted by the effects of the COVID-19 pandemic. Site visits, supply acquisitions, labs, staffing, and funding all became obstacles as sponsors, CROs, and site staff struggled to know how best to respond. As we saw in our series of surveys with site staff around the world, trials slowed dramatically in the early days, sponsors and CROs provided a patchwork quilt of support, and staff were fatigued but determined.

As the months whined on, lessons were learned, solutions were attempted, and trial programs began to rebound. A recent article published in FierceBiotech showed that clinical trial programs are up 85% from April. The buoy is largely attributed to strategies like using local labs and technologies to enable remote monitoring and site visits. Sponsors, CROs, and site staff became creative while doing what they do best—testing. This time, not just of therapeutics, but of research strategies and techniques. An article in Applied Clinical Trials outlined the range of technologies and decentralized approaches used in clinical trials globally over the past several months. Telemedicine, eConsents, and home delivery all seem to be viable, while others, like wearables, are struggling to gain traction.

Focusing on the how, not just the how many

When evaluating the effect of the COVID-19 pandemic on clinical trial development, the best metric may not be the number of active programs, but the way those trial programs are being conducted. The trials conducted over the past several months give us not just data on therapeutics, but feedback on the solutions that overcame pandemic-related challenges, which have also served to bring much-needed patient-centricity to clinical trials.

Parallel to clinical research should be an evaluation of those solutions. Researching solutions will produce the data needed to improve clinical trial programs of the future. The industry is in the process of creating best practices, but they will only endure if it takes the time and effort to learn from them.

For decades, Clinical SCORE has been helping sponsors and CROS glean insights from the experiences of clinical trial site staff and patients needed to optimize protocols for ongoing and future trials. How can our proprietary methodologies help you capture the unanticipated learnings of your ongoing research? Reach out to Blaine Cloud at Blaine.Cloud@clinical-score.com and we can begin to answer this question together.