Centralized Processes Facilitate Clinical Trial Enrollment During COVID-19
Key findings
- Medical centers face difficult choices about prioritizing randomized clinical trials of COVID-19 interventions, as well as logistical challenges in conducting multiple trials simultaneously focused on the same patient population
- Massachusetts General Hospital has established a centralized scientific review committee to determine which trials will be launched and to continuously evaluate proposals for new studies
- A core group of physicians screen and rescreen patients for trial eligibility daily, and a core group of research staff assist study teams with interpretation, blood draws, study drug administration and data entry
- There is a pressing need for medical centers across the U.S. and the world to come together to create better clinical trial infrastructure in order to answer the many open questions about how to best care for patients with COVID-19
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If every study registered on ClinicalTrials.gov as of mid-June, 2020, meets its target enrollment, then less than 4% of U.S. patients diagnosed with COVID-19 will have been enrolled in a randomized, controlled trial. There is a real danger that without a coordinated research approach, clinical gestalt and idiosyncratic practice variation will govern the treatment of most patients hospitalized with COVID-19.
Yet there are hundreds of proposed interventions for COVID-19. Medical centers face difficult choices about prioritizing trials and logistical challenges in conducting multiple trials focused on enrolling the same patient population. Crystal M. North, MD, MPH, physician in the Division of Pulmonary and Critical Care, Michael Dougan, MD, PhD, physician in the Division of Gastroenterology, and Chana A. Sacks, MD, MPH, physician in the Division of General Internal Medicine, of Massachusetts General Hospital, recently described Mass General's approach to COVID-19 clinical trial oversight in The New England Journal of Medicine.
Central Review
In addition to the ethical oversight of the institutional review board, Mass General established a centralized clinical trials steering committee and scientific review committee to determine which trials would be launched and continuously evaluate proposals for new studies. The committees consider:
- Scientific merit: How important and answerable is the research question?
- The number of participating sites: Is this a multisite trial that could continue enrolling if case numbers fell here?
- Logistics: How much personal protective equipment will be required to complete the study?
The goal of the committees is to ensure the trials selected are feasible, diverse in approach and target multiple viral and host pathways.
Centralized Processes
Every patient newly admitted to the hospital or newly diagnosed with COVID-19 is centrally identified and screened based on each trial's inclusion and exclusion criteria in an organized manner to ensure equitable access for patients. Informed consent resources are available in every needed language. A core group of research staff is available to draw blood for laboratory tests, administer study drugs and coordinate follow up after discharge. All inpatients are regularly rescreened to identify anyone who might newly meet eligibility criteria as their clinical course evolves.
Because new scientific knowledge is rapidly emerging, this system is designed to be flexible. For example, following the first published report from the ACTT-1 trial that showed the benefit of the antiviral remdesivir, all currently enrolling studies either had to allow patients to receive remdesivir or could approach patients only after they were evaluated for remdesivir eligibility as part of standard care under the emergency use authorization.
Early Results
To date, Mass General has screened more than 1,300 inpatients for 12 COVID-19 clinical trials, with new trial protocols under review for inclusion in the Mass General trial portfolio. More than 350 patients have been enrolled.
Future Directions
Mass General is working to maximize trial access and enrollment to answer ongoing questions about optimal treatment of COVID-19 and to adapt this research infrastructure to answer questions beyond COVID-19.
Medical centers across the U.S. and the world need to develop better coordination of critical trials. Infrastructure fixed in a single location is inadequate to address a virus that is moving through geographic hot spots.
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