December 22, 2020
This past year has been unlike any other for the clinical research community. We have had to balance the need for research results with protecting research staff and our research participants. With everyone’s cooperation we have been able to find the right balance. Over the past two months our clinical research activity is steady at about 75% of what it was one year ago. We have several research coordinators who developed COVID-19 disease (not related to their work), but by using appropriate PPE, we have not had demonstration of transmission to any research participants or within research staff. In our pulse surveys, research teams report that while recruitment is more difficult, they believe the research environment is safe and that clinical research could even be expanded to some extent.
Our recommendations are as follows:
- The entire research team should meet and decide which protocols are most important, balancing no benefit studies and therapeutic trials, and focus on safe implementation of the most important protocols. While some sponsors are beginning to pressure teams to meet recruitment goals, safety needs to remain the highest priority.
- Do not let your guard down. Every member of the research team needs to stay home if they have symptoms, use appropriate PPE at all times, socially distance at much as possible, and conduct your research in the safest environment possible. Please consider whether the ICTR Clinical Research Units offer a safer setting for your research. In addition, we encourage you to utilize DocuSign for remote consent (research [email protected]). We have created guidance for research teams about COVID-19 practices and a new best practices for research home visits.
- If you have concerns about the wisdom of continuing a research study, feel free to discuss this with your departmental research leadership, the IRB, the research advocates within the ICTR, Liz Martinez ([email protected]) or Daniel Ford ([email protected]).
Thank you to everyone who has done their best to move our clinical research program ahead in the past year. It is highly likely that potential research participants will ask more questions about safety and COVID vaccination implementation as they make decisions about enrollment in studies. We will provide you with as much data as we can to help you make data driven decisions.
Warm wishes for a Happy Holiday season.
Best,
Daniel E. Ford, MD, MPH
David M. Levine Professor of Medicine
Vice Dean for Clinical Investigation
Director, Institute for Clinical and Translational Research
