COVID-19 Challenges
This past year accelerated vaccine trials, and study pauses, holds and telehealth added new and unexpected levels of difficulty. Many studies closed to new enrollment. Others were put on hold or withdrawn by the site or the sponsor.
In the early days of COVID-19, research coordinators and their teams struggled to comply with ongoing protocols during lockdowns. Guidance from IRBs and sponsors changed daily. Coordinators were instructed to keep good records of all the adaptations they used, so they could remember what worked and what did not when the second expected surge came.
Research teams developed methods to obtain informed consent remotely. Study procedures were streamlined and adapted. Documentation of missed and delayed assessments became commonplace. The definition of a protocol deviation changed as the unusual became the usual. Shipping an investigational product to patients became acceptable.
Research staff and resources were pulled from ongoing clinical trials to vaccine trials.
For sites doing only non-vaccine trials, income was greatly reduced.
In the future, clinical research will be categorized before COVID-19 and after COVID-19. Reduced study visits, collection of assessments by patients at home and telehealth will become part of whatever passes for normal.
A research coordinator will make it happen.
Donah Zack Crawford, MA, has been the director of clinical trials for The Arthritis Group, Philadelphia, for 22 years, and acted as lead coordinator on more than 150 trials. She has presented programs on research areas at ACR/ARP annual meetings and served on many ARP Committees. She is currently a member of the ARP Executive Committee. She was the 2020 recipient of the ARP’s Ann Kunkel Advocacy Award.
Jeff Newcomb, BS, ACRP-PM, CCRC, is the national study coordinator for the Veterans Affairs CSP 594 STOP Gout Study (P.I. James O’Dell, MD), as well as a project manager for the University of Nebraska Medical Center Division of Rheumatology, Omaha.
