Changes in Clinical Trials During COVID-19

May 25 , 2020

During the COVID pandemic, there has been a large impact on the clinical trials industry. Due to stay-at-home orders and social distancing, it becomes increasingly difficult to conduct clinical trials at the hundreds of thousands of study sites around the world, including ours here at the Clinical Research Center of the Carolinas. When patients limit their time away from home, an essential measure to curb the spread of the virus, it is more challenging for them to participate in a study.

There are a few specific obstacles clinical researchers face.  Firstly, both trial participants and trial staff are limited in their mobility. As a result, participants cannot receive regular monitoring and it is more challenging to distribute medication. Subject oversight is imperative to ensure both safety and data quality. Another obstacle falls in the technology category. Since office visits are less common, new ways to join trials and to collect data are essential.  The last item to consider is on the supply side. Study sponsors must plan how much of a drug to order, ship and carry. Given the unpredictable nature of a pandemic, such uncertainty is inevitable, at least for the time being.

A common saying is that necessity is the mother of invention, a key principle in rethinking clinical trials. Study sites are responding to the circumstances, by taking advantage of telemedicine. For example, using monitoring systems that operate with telehealth platforms enables site staff to contact and engage with the participants remotely. When there is more engagement, there is also more trust and thus a more reliable study outcome. Decentralization (taking the clinical trial to the patient) is another way clinical trials are changing in response to the pandemic. By conducting study visits with patients in their home, they are more comfortable and more likely to participate. Many breakthroughs in virtual clinical trials are still in the future, but the pandemic has motivated pharmaceutical companies to accelerate these changes.

Medicine itself is an ongoing research project. During COVID, that research will continue, although most certainly with a remote component. Clinical trials must move forward, and the culmination of efforts from sponsor companies, practices and software engineers will leverage the best technologies to make it happen. Here’s to the longevity of current and future patients!