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# Raise the Bar on First-in-Human Trials: Ethicists
- URL: https://www.fdaweb.com/raise-the-bar-on-first-in-human-trials-ethicists/
- Published: 2017-02-02T12:00:00.000Z
- Updated: 2026-09-14T22:04:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137893

Biomedical ethics researchers from Canada’s McGill University say that the efficacy of drugs should be considered before they are allowed to enter first-in-human trials. Writing in a *Nature* [commentary](http://www.nature.com/news/consider-drug-efficacy-before-first-in-human-trials-1.21384?ref=fdaweb.com), the ethicists say that “more thorough assessments of clinical potential before trials begin could lower failure rates and drug development costs. Currently, more than half of drugs that reach later-stage human testing fail because they do not demonstrate efficacy.”

Questions the authors suggest be asked to assess clinical promise are: **(1)** what is the likelihood that the drug will prove clinically useful; **(2)** assuming the drug works in humans, what is the likelihood of observing the preclinical results; and **(3)** assuming the drug does not work in humans, what is the likelihood of observing the preclinical results.

The authors suggest these steps to address the issue: 

- require that documents that drug sponsors submit to investigators and ethics committees include negative and unfavorable results from animal studies if they exist, and summarize outcomes from clinical tests of other products in the same drug class;
- allow first-in-human trials to proceed only after careful vetting of the preclinical evidence by people with the appropriate expertise who are independent of the drug sponsor, perhaps a centralized first-in-human advisory system combining ethical and scientific review; and
- make appraisal of clinical promise rigorous and structured.

Steps that could be taken quickly, the authors say, include convening a National Academy of Sciences panel to advise on how best to harness preclinical evidence to evaluate clinical potential, and encouraging university ethics boards to appoint ad hoc members with relevant medical expertise to summarize and evaluate proposed early phase trials.