Clinical trials are a unique segment of the healthcare industry experiencing what is becoming the all too familiar effect from the coronavirus global pandemic. To understand this effect more deeply, Clinical SCORE recently surveyed 363 clinical trial sites across a range of settings and provider specialties spanning 42 countries. Results of the survey quantify the toll that treating patients with COVID-19 is taking on site staff personally, as well on the ability to obtain supplies, equipment, and labs.
The results also show a deep dedication of site staff and attempts to maintain clinical trial schedules. Ninety-two percent have attempted to keep trials on schedule, with virtual site visits being the most commonly deployed approach (36% of trial sites). Still, the difficulty in modifying protocols was too great for the 35% of enrolling sites that chose to stop seeing patients.
Sponsors and CROs are a lifeline for trial sites wanting to stay the course. Survey respondents gave clear recommendations, outlined in a second article published in Applied Clinical Trials, as to the type of support that would be most welcome:
- Better communication, including guidance, site staff safety guidelines, and options for data collections. On the other hand, palliative calls and emails are not welcomed.
- Study protocol modifications to accommodate deviations related to COVID-19
- Suggested changes, such as conducting alternate visits (virtual, home, or drive-through visits) and how to better accommodate patients who have time or travel constraints
This survey is one vehicle for communicating the type of support that could most greatly benefit clinical trial sites. Ongoing and constructive communication will be essential to helping clinical study programs continue on, as we collectively learn how to navigate these uncharted waters.
Clinical SCORE has been helping study sponsors gather insights and information from study sites for 15 years. We believe, now more than ever, in the importance of doing so. For more information on our methodology or to help us learn about your clinical trial program so that we can begin to understand how to help, please reach out to Blaine Cloud at Blaine.Cloud@clinical-score.com. Download the full study report, The Effect of COVID-19 on Clinical Trials: Insights From the Inside, for more detail on the survey design and results.