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New U.S. Rule to Expand Requirements for Publication of Clinical Trials

Vice President Joe Biden’s effort to encourage faster cancer cures was one factor leading to announcement

Federal health officials will soon be requiring scientists and companies to make public more details of a broader range of medical research studies, even if the results are disappointing to the researchers or to companies sponsoring the research.
A rule published Friday from the Department of Health and Human Services will expand the requirements for clinical trials’ publication to include most studies of products not yet licensed by the Food and Drug Administration. Bolstered by a companion policy announced Friday by the National Institutes of Health, the government beginning next year will require more types of bad side effects to be reported and will set out legal penalties for scientists or companies that don’t comply.
The NIH will now plan to cut off future research funding to institutions that don’t comply.
Francis S. Collins, the director of the NIH, said that while there are more than 224,000 clinical studies listed on the website, researchers have “a disappointing track record” in making the results of studies available when the results are unfavorable. He called this situation “simply not acceptable.”
The NIH’s complementary policy will apply to all NIH-funded studies. The NIH will generally require that results of such research be posted on, and Dr. Collins said failure to do so “may jeopardize future grant funding” for the university or institution, not just the individual researcher. The idea, he said, is to “maximize the value of clinical trials.”
Dr. Collins said one of the factors leading to the Friday announcement was Vice President Joe Biden’s Cancer Moonshot effort to encourage faster cures for cancer. Mr. Biden has spoken extensively, and passionately, about the need for scientists to make their research findings broadly and quickly available to other researchers and to patients.
Jerry Avorn, a Harvard University medical professor and chief of pharmacoepidemiology at Brigham and Women’s Hospital, called the steps “an important and much-needed development. Most people don’t realize that if a company runs a clinical study of a drug and finds that it doesn’t work, or that it has dangerous side effects, until now it’s been possible for them to bury those findings and never let them see the light of day.”
The Pharmaceutical Research and Manufacturers of America, an industry group, didn’t immediately respond to calls for comment.
FDA Commissioner Robert M. Califf said researchers generally will need to post the original protocols for their research, a move that could discourage redefining the goals if answers are deemed unfavorable.
The clinical studies at issue in the HHS rule will generally include research that evaluates drugs, medical devices or biological products that will be regulated by the FDA. To be covered, a study must include one or more sites in the U.S., a product manufactured in the U.S. or must be conducted under certain FDA regulations. The rule also sets out a checklist to guide researchers about what studies are covered and who is responsible for filing information.
The HHS rule gives researchers and companies 90 days after Jan. 18, 2017, to come into full compliance. The rule was proposed two years ago, but was made final Friday following nearly 900 comments.
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