Are regulations too lax for first-time participants in clinical trials?

Researchers from McGill University believe the authorization process for first-time participants in clinical trials is too lax. In a paper published in Nature, researchers argue for a new set of measures for admitting first-time trial participants.

“While regulators in North America and Europe evaluate safety before human trials can proceed, they do not currently demand meaningful evidence for potential efficacy,” wrote McGill bioethicist Jonathan Kimmelman and Carole Federico in a commentary. "We believe that many (first-in-human) studies are launched on the basis of flimsy, under-scrutinized evidence."

With the current method, when a trial doesn’t work out, financial, research and participant resources are wasted. The measures developed by the researchers include:

• Requiring drug sponsors to include negative results from animal studies in documents sent to ethics committees.
• Only allowing trials to continue only after vetting of preclinical evidence is approved by independent experts.
• Encouraging reviews of a larger base of evidence in determining the probability of the drug being tested.

“Critics of the proposal may object that this approach could increase costs and time for drug development,” said researchers. “But more-thorough assessments of clinical potential before trials could reduce failure rates and thereby offset development costs.”