Why the bar needs to be raised 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 . 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 . 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 McGill bioethicist Jonathan Kimmelman and PhD student Carole Federico 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 healthcare systems in the form of higher drug prices. The argument for better scrutiny of animal studies may be especially timely, since the incoming U.S. president has indicated he intends to weaken requirements for clinical evidence of efficacy before drugs are approved. A clinical trial in France that led to the death of one person last year and hospitalization of five others has drawn intense scrutiny into how the drug's toxicity could have been anticipated, the researchers note.