The U.S. Department of Health and Human Services, DHHS, issued a news release on September 16, 2016, announcing a final rule that will go into effect on January 18, 2017. The final DHHS Rule affects medical related clinical trials. Researchers will have 90 days to comply.
The new rule expands the existing rule on the submission and summary reporting of most clinical trials involving drugs, biological and device products that are regulated by the U.S. Food and Drug Administration, FDA. It does not apply to phase 1 drug and biological product trials or to device product feasibility studies that are small.
Clinical trials must be reported in the National Institutes of Health, NIH, online database. As a result of the new rule, NIH issued a complementary policy that expands required reporting to include all trials that are NIH funded. That policy expands the rule by including phase 1 drug and biological products trials or device product feasibility studies that are small.
“Access to more information about clinical trials is good for patients, the public and science,” said NIH Director Francis S. Collins, M.D., Ph.D. “The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health.”
Clinical trials are an important part of determining whether drugs and devices will actually do what they are designed for. Real people are allowed to volunteer for the trials. They become human guinea pigs, so to speak. Some are given placebos (a drug or product that does not contain the actual product being rested) and some are given the real medicine or other product being tested so that an actual response can be measured. There are people that, given a definition for what the product is meant to do, give a favorable response simply because of the suggestion that it can help. Giving placebo’s can help measure whether the response is real or a result of a psychological response to believing that the product helped.
The database is of use for several reasons: it allows other researchers to determine whether their proposed research has already gone through trials, and allows individuals to sign up to participate in the trials. It also is a venue where researchers are required to publish their findings, rather than hide them from other researchers. This could, according to NIH, keep researchers from hiding the results of clinical trials until they have a result they are looking for, or that is favorable to the drug or device that they would like FDA approval for.
Overall, the rule is an improvement in the attempt to keep drugs and devices off the market that do not actually do what they are designed to do. It will help keep unscrupulous researchers, say big drug companies, from running trials until they get the result they want.
Volunteers for clinical trials are an important part of research. The commissioner of FDA, Robert M. Califf, M.D. stated that: “When people participate in clinical trials, they are volunteering to create generalizable knowledge to help others in the future and we want their participation honored by ensuring that the existence of trials and their results are available to all patients and their healthcare providers, as well as researchers,” said FDA Commissioner Robert M. Califf, M.D. “The FDA will help ensure compliance with these new requirements so that patients and providers can have confidence in and access to significantly more clinical trial information, and researchers can improve clinical trial focus and design.”
The new rule and NIHs new policy promises to help stop incidences of misreported and redundant research. Companies will no longer be able to sway results to obtain the desired result. While this is not a “fix”, it is a good start!
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