A Call to Coordinate Nationally on COVID-19 Clinical Trials

“The time has clearly come for a national coalition to coordinate hypothesis-driven clinical research trials to give the medical community the evidence it needs to safely and effectively treat and prevent COVID-19.” So argues Tom Mihaljevic, MD, CEO and President of Cleveland Clinic, in a new editorial he jointly authored with Gianrico Farrugia, MD, and Andrew Badley, MD, both of Mayo Clinic.

The editorial, published by STAT on Oct. 26, notes that while more than 2,000 interventional clinical trials for COVID-19 are listed on clinicaltrials.gov, many are investigating similar agents “and therefore competing for participants, infrastructure capacity, and funding.”

The three physician leaders advocate for a national, nonprofit clinical trials coalition to address COVID-19 by coordinating similar but disconnected studies for maximal returns and efficiency. The coalition should include experts in virology, immunology, public health, ethics, healthcare disparities, trial design and statistics, the editorial argues.

Functions of the proposed coalition would include (among others):

• Setting forth a uniform standard of care to facilitate better treatment comparisons
• Implementing guidance on outcome measures for each stage of studies
• Offering incentives for early-phase trials to determine appropriate dosing prior to wider studies
• Developing processes for testing therapy strategies and vaccines
• Choosing trial sites that give priority to addressing patient needs and health disparities
• Guiding the ethics of reporting therapeutic study results in preprint publications

Citing their own organizations’ use of this type of coordinating group approach for research related to COVID-19, the three physicians contend that similar coordination at the national level will optimize resource use and help lead to “rigorous, generalizable, and definitive results.”

For the full editorial, click here.