"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."

AD

AD

Some of the changes have been in the works for years. But the effort was hastened by Vice President Biden's threat in June to cut off research funding to medical institutions that don't report the results of their research. Biden wants more information disseminated more quickly to aid research in the Cancer Moonshot that he is leading.

Collins noted that a 2014 review of 400 research studies showed that 30 percent had not reported their results to clinicaltrials.gov, the government repository for such information, four years after completion. "That's clearly unacceptable," Collins said. Under a 2008 rule, federally funded researchers are supposed to deposit their results within a year of a clinical trial's completion. Another examination of 51 academic medical centers revealed that 43 percent of their clinical trial results were not published two years after completion.

Biden said that fewer "than five percent of cancer patients enroll in a clinical trial, often because patients and doctors don’t know what trials are available." About 31 percent of the open trials on clinicaltrials.gov are for research related to cancer.

AD

AD

Beginning on Jan. 18, researchers in most studies of therapies and devices funded by NIH or regulated by the Food and Drug Administration will have 90 days to come into compliance with the new rules. For some universities that have been lackadaisical about following existing policies, that may require some effort. The NIH gave out nearly $24.5 billion in research grants in fiscal year 2015.

The new rules issued by the Department of Health and Human Services expand the kinds of research that must be registered, demand quicker registration and require more information about results, the participants involved and how the research was conducted. The government also wants more information on research that failed to achieve its goals, which, Collins noted, often can be valuable to future studies, and therapies that have not yet been approved by the FDA.

Collins acknowledged that the government cannot ethically halt ongoing clinical trials as an enforcement technique, but he said NIH intends to be vigilant about blocking future grants for institutions that do not comply.