The U.S. should consider establishing a national registry for healthy volunteers participating in phase I clinical trials to guard against the risks of overlapping enrollment and protect data integrity, Pharma Times reports from a commentary in the Journal of the American Medical Association.
David Resnik of the U.S. National Institute of Environmental Health Sciences and Greg Koski of the James Mongan Institute for Health Policy wrote that some people in the U.S. have enrolled in as many as 80 phase I studies, to the extent of pursuing research participation as a full-time job.
This intense commitment heightens the risk of potentially dangerous drug interactions between investigational agents and medication taken by the study participant either currently or recently, Resnik and Koski wrote. The risk is especially pronounced in phase I trials “designed to induce toxicity to determine the maximum tolerable dose.”
While there is a standard exclusion interval of 30 days for phase I trials in the U.S., and protocols should ideally specify an appropriate waiting period based on the half-life of the investigational drug, professional volunteers “have a strong financial incentive to conceal recent or even current enrollment in phase I studies,” they wrote.
A number of countries, such as France and the U.K., already have national registries for healthy volunteers participating in clinical research, Resnik and Koski pointed out.
“To adequately deal with the problem of overlapping enrollment, a national registry is needed,” Resnik and Koski argued. This should be linked to databases providing investigators with key information about studies the volunteers have participated in, such as interventions, drugs taken, estimated duration of research and contact information. Costs “would be modest and could be financed by fees from study sponsors.”