Drug companies must now disclose most clinical trial results

For years, drug and medical device companies have been able to conduct clinical trials and then, depending upon results, determine which ones to make public. They were not required to let the public know about poor outcomes of clinical trials, even for a drug receiving FDA approval based on a different clinical trial with a beneficial outcome. Now, these companies must disclose most clinical trial results, even if they show a drug or device may not be safe or effective.

The U.S. Department of Health and Human Services has issued a final rule expanding the conditions under which pharmaceutical companies, medical device companies and manufacturers of biologics must register clinical trials and disclose summary results information on ClinicalTrials.gov, including information about harmful side effects.  The National Institutes of Health has issued a policy that complements the HHS policy for registering and disclosing summary results information on ClinicalTrials.gov for all NIH-funded trials, including trials that are not subject to the HHS final rule.

NIH Director Francis S. Collins, M.D. said that he wanted to make sure the public got maximum value from clinical trials, whether funded with government money or private money. “Access to more information about clinical trials is good for patients, the public and science.”

The goal of clinical trials is to ensure that health care drugs and devices are safe and effective. They sometimes also indicate when one medical treatment is better for a specific condition or particular subpopulation (e.g., children, older adults) than another.

These new requirements should make it easier for people to learn about clinical trials in which they might be interested in participating as well as new possible treatments for their conditions. And, more information about clinical results will enable patients and doctors to make more informed decisions about appropriate treatments. It will also help researchers design studies based on more information about clinical trial results.

The HHS final rule requires companies to register and disclose summary results for trials of most products that the FDA regulates. However, phase 1 drug and biological products and small studies to determine the feasibility of device products are excluded from the requirement. The NIH policy extends to all NIH-funded trials, including phase 1 clinical trials of FDA-regulated products and small studies to determine the feasibility of products; it also applies to products that the FDA does not regulate, including behavioral interventions.

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