Advertisement

Report calls for strengthened standards in human trials

Scientists want to see standards for authorizing human trials strengthened.

By Amy Wallace

Jan. 30 (UPI) -- Researchers from McGill University in Montreal are calling for standards to be strengthened in early-stage human drug trials.

In a new report, researchers are urging the standards for human drug trial approvals to include evidence of potential efficacy before the trial begins.

Advertisement

"We believe that many [first-in-human] studies are launched on the basis of flimsy, under-scrutinized evidence," Jonathan Kimmelman, a bioethicist, and Carole Federico, a Ph.D. student, at McGill University and co-authors of the report, said in a press release.

The researchers cited financial burdens and health risks from ineffective drug trials. The money wasted on ineffective drug trials are usually passed down to healthcare systems in the form of higher drug prices and patients who participate in ineffective drug trials miss out on effective treatments that could have significant health benefits for them.

An example of this was a clinical trial in France recently that led to the death of one person and the hospitalization of five others.

"Commercial interests and hope, alone, cannot be trusted to ensure that human trials launch only when the case for clinical potential is robust," Kimmelman said. "Ethics requires a clear-eyed evaluation of a drug's potential."

Advertisement

The report recommends requiring drug sponsors to include negative results from animal studies in information submitted to ethics committees, allowing trials to only proceed after thorough vetting of preclinical evidence by independent experts, and urging reviewers to look at a broad base of evidence in considering the probability a drug will be useful.

The report was published in Nature.

Latest Headlines