American health officials, in an effort to improve transparency in clinical trials, have proposed new rules that would expand what researchers conducting trials of drugs or devices are required to publicly report.
The proposed new rules have grown out of concerns that information of crucial interest to both physicians and patients coming from trials -- particularly unfavorable study results -- is being kept secret, officials with the National Institutes of Health said.
"Medical advances would not be possible without participants in clinical trials," says NIH Director Francis S. Collins. "We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld."
The proposed rule clarifies requirements for clinical researchers to register trials and submit summary trial results to ClinicalTrials.gov, a publicly accessible database operated by the NIH's National Library of Medicine, if their trials are even partly funded by the NIH.
Previously there has been no such requirement, and clinical trials that are conducted without NIH funding on experimental or approved drugs that are regulated by the U.S. Food and Drug Administration would still not have to report trial safety data.
However, in a significant enlargement of the current requirements, researchers would no longer be allowed to keep data secret if, for instance, a trial determined a drug or other therapy was ineffective.
A 2013 study of hundreds of clinical trials found almost half never published any results.
And of 178,000 studies registered on ClinicalTrials.gov, summary results have been posted for just 15,000.
"This proposed rule would close an important gap" by ensuring that further information generated by clinical trials is made publicly available, FDA commissioner Dr. Margaret Hamburg said in an agency statement.
It would also help those conducting trials to focus on the most important and promising research, reduce trials that duplicate each other, facilitate the development of new therapies and help quickly identify products that are ineffective or unsafe, the said.
The NIH says it will be accepting public comment on the proposed rule change for 90 days.
"Many people have been doing experiments on people and not sharing the results, even with federal dollars," says Harlan Krumholz, a cardiologist and health policy professor Yale University. "This is saying we are going to do science the right way and use our considerable influence to make sure it happens."
