New rules to make clinical trials more transparent
New rules governing clinical trials will come into force in the US in the New Year, which mean even disappointing results of testing therapies and devices must be disclosed. There will be big penalties for universities and other research institutions that do not comply.
The changes are important. Most trials that fail in the early stages are never published which can skew information about the potential harm of experimental therapies.
The new regime will be welcomed by activists such as Ben Goldacre, a British doctor campaigning for root and branch reform to the ways clinical trials are conducted and reported – he was interviewed by Cosmos about his mission in August.
“We, as a community, have a disappointing record of making those results available,” Francis S. Collins, director of the National Institutes of Health, said in a briefing for reporters.
“This is about maintaining the trust that we have with participants in clinical trials who volunteer to take part in these efforts with the expectation that it will add to the body of knowledge.”
The rules, laid down by the US Department of Health and Human Services (HHS) and the US National Institutes of Health (NIH), apply only to work done through agency grants but acknowledge the ethical issues of making clinical trials transparent.
“I think a lot of major universities just miss the point that if you do an experiment on a person and get consent, you really have the obligation to make the results known,” Robert Califf, head of the US Food and Drug Administration (FDA) told Nature. “This is fundamentally an ethical issue.”
The new rules were brought in partly in response to a study that showed that, of 600 randomly selected trials the result of only 50% were published.
The new regimen comes into force from 18 January.