The news is flooded with stories of the effect of the coronavirus global pandemic. Some are anticipatory, some are anecdotal. Some are accounts from industry professionals, some of patients. Few, though, provide data-driven insights into the unique experiences of clinical trial sites.
Clinical SCORE reached out to over 350 clinical trial sites across a range of provider specialties, settings, and 42 countries and found clear trends in the results, which were elaborated on in a recent Applied Clinical Trials article.
Key areas of major impact
Nearly two thirds of sites report that the coronavirus has had a substantial impact on clinical trials, including the postponement of recruitment and enrollment and an inability to get patients to come in for study visits. In response, 36% of trials have been moved to virtual visits, a trend worth watching in the coming weeks.
These challenges and changes have had a notable effect on trial site staff. Nearly 7 of 10 sites report that their front-line healthcare providers are negatively affected by COVID-19. It appears that the greatest issues are getting lab results and study supplies, as trial needs compete with the care needed for patients with COVID-19.
Obviously, the ability of sites to maintain trials during the pandemic will affect sponsors and CROs as well. In just these few weeks, a third of sites are reporting protocol deviations, as they struggle to reach patients, experience procedure delays, and are prevented from getting the labs and supplies needed to stay the course. Only time will tell the longer-term impact of protocol deviations and study suspensions.
Despite these challenges, study sites continue to demonstrate their dedication. An amazing 92% of study sites have attempted to keep trials on schedule. Study sites surveyed gave clear recommendations for ways that sponsors and CROs can help in doing so, including better communication about safety guidelines and proactive adjustments, as well as suggestions for how to modify trials to accommodate current needs and restrictions.
Listening and learning
While there is no crystal ball, sponsors and CROs can listen to the needs and recommendations of study sites. The full survey report is a platform for those voices and can be the foundation of recommendations and preparedness for the coming weeks. For more information on the survey methodology or results, or to find out how Clinical SCORE can help you learn from your study sites, contact Blaine Cloud, Ph.D., at firstname.lastname@example.org.