Wall Street Journal: New U.S. Rule to Expand the Requirements for Publication of Clinical Trials

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 ClinicalTrials.gov, 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 ClinicalTrials.gov, 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 PresidentJoe 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.”

Originally published by the Wall Street Journal, full article here. Author Thomas M. Burton.

Additional information on the final rule regarding 42 CFR Part 11