Raise the bar for human clinical trials


Standards for authorizing first-time trials of drugs in humans are lax, and should be strengthened in several ways, McGill University researchers argue in a paper published recently in Nature.

While regulators in North America and Europe evaluate safety before human trials can proceed, they do not currently demand meaningful evidence for potential efficacy, write Dr. Jonathan Kimmelman, Associate Professor, Biomedical Ethics Unit/Social Studies of Medicine, and Experimental Medicine PhD student Carole Federico, MSc’13, in a commentary article. “We believe that many (first-in-human) studies are launched on the basis of flimsy, under-scrutinized evidence.”

Trials of ineffective therapies place burdens on society even if research participants aren’t harmed directly, the researchers argue. Drug development soaks up financial and research resources; patients and healthy volunteers involved in testing a dud treatment miss out on more promising ones; and expenses wasted on ineffective therapies are often passed on to health care systems in the form of higher drug prices.

The McGill researchers propose several measures to reinforce standards, including:

  • Require drug sponsors to include negative results from animal studies in documents submitted to investigators and ethics committees;
  • Allow trials to proceed only after careful vetting of the preclinical evidence by independent experts;
  • Encourage reviewers to consider a broad base of evidence in assessing the probability that a drug will prove clinically useful: for example, how have other drugs in the same class performed in trials?

(McGill Newsroom)
Dr. Jonathan Kimmelman, Associate Professor, Biomedical Ethics Unit/Social Studies of Medicine (Photo: Robert Streiffer)

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