This article was brought to you by, Greenphire
We rise by lifting others. – Robert Ingersoll
Clinical Trials Day is a day to recognize those involved with clinical research, but this year is distinct as we recognize frontline heroes of the pandemic. In 2021, the ACRP is raising awareness of clinical research under the theme of ‘we rise’. Rising up to the challenge is exactly what clinical researchers, participants, research sites, pharma sponsors, and contract research organizations did during a year where there was no business as usual, and the need to pivot was stronger and more urgent than ever. 2020 was a refining year for everyone involved in clinical trials, one that pressurized and galvanized, ultimately resulting in stronger and more innovative trials.
From participant to sponsor, clinical trials were affected in all facets throughout the course of the pandemic. According to a survey from the Society for Clinical Research Sites (SCRS), 78% of research sites reported an increased workload due to COVID-19. Not only were hospitals, doctors offices and university settings shouldering additional burden due to COVID, but their employees faced health concerns when treating participants. Even so, there have been so many examples of those who rose to the challenge. Additionally, participants faced challenges related to job loss, changes to transportation availability, and the need for childcare with school closings, resulting in lower participant retention rates. Any of the changes made to enable clinical trials to continue came with associated costs. Sites experienced new costs related to remote monitoring, PPE, home visits, and medication shipments. Sponsors had to find quick and effective ways to support their sites, with consequences in efficacy and enrollment.
What did it take, exactly, for clinical trials to continue through a year like 2020? It took an ‘all in’ attitude, quick shifts in regulation, adoption of technology, and the mobilization of thousands of participants – for COVID-19 studies and beyond. The mechanisms of patient interaction largely changed, and telehealth saw its moment. Of site respondents in a 2020 site survey by Greenphire, 69% said they are leveraging technology for at-home patient care. This included virtual health visits and the delivery of medication to homes. Sites and sponsors were intentional about paving the way for participants to be able to remain in trials, by increasing the removal of financial and logistical burdens to patients, like transportation, and costs associated with participation.
Technology and new approaches were the key to enabling clinical trials to continue. In a survey by the Society for Clinical Research Sites, 62% of respondents indicated they did not pause operations during the pandemic. It has been proved that trials can continue in the current environment, and as this becomes increasingly clear, enrollment is picking up and clinical trial activity has recovered, now hitting historically high levels.
Of course, this all works in tandem with the endless dedication of sites. In a site survey that Greenphire conducted, we learned that study investigators have worked diligently to ensure that patients remain engaged, with regular phone calls, emails, and text messages. As one respondent noted, “I’m proud to say that as Study Coordinator I have been in weekly contact with each of our enrolled families either by phone or email to reiterate the importance of their involvement in our research and our desire to return to normal operations as soon as possible.” Personnel also reported giving out personal cell phone numbers and making themselves more available to participants.
The pandemic has been a proof test for clinical trials. What is evident is the added value to patients, sites, and sponsors of using technologies that accommodate flexibility and reduce patient inconvenience. Sponsors, CROs, and sites have implemented automated payments, provided simplified and pre-paid transportation for participants, and have taken additional steps to facilitate participation. Accordingly, 86% of pharmaceutical sponsors say that they are actively seeking to increase the use of technology to better support decentralized trials. In 2020, many studies employed at-home monitoring devices coupled with patient micropayments to ensure compliance of study activity outside of the clinic.
Hybrid trials were already a topic of conversation pre-pandemic and now that this dynamic has proven successful, this trend will no doubt persist in the future. Technology designed to improve the site and patient experience can increase retention in these scenarios, and a solid financial infrastructure will remain essential.
While we see this being year unlike any other which celebrates and recognizes those involved with clinical trials, rising to the challenge embodies the core of trials themselves. Clinical research assesses ongoing diseases, conditions, issues, etc., and seeks to root out causes and pursue treatment options, forging new treatment options for healthcare as a whole. On this Clinical Trials Day, we thank all of those who rose to the challenge of COVID-19, and who continue to rise each day to pursue a brighter future for us all.