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After months of debate, clinical research activity regulated or funded by the government must adhere to revised guidelines regarding transparency. A final rule published by the Department of Health and Human Services states that all beyond Phase I FDA regulated and NIH funded clinical trials must comply with the new requirements.
The campaign to achieve greater transparency in clinical research activity regulated or funded by the federal government, including the results of those studies, is moving forward after months of debate. A final rule published by the Department of Health and Human Services (HHS) clarifies that all studies regulated by the Food and Drug Administration beyond phase 1, and all clinical trials funded by the National Institutes of Health (NIH), must comply with revised requirements for posting study information on the ClinicalTrials.gov website and then disclose the results of those studies. A companion policy statement from NIH provides additional provisions for NIH-funded investigators.
This final rule, which was authorized by the FDA Amendments Act (FDAAA) of 2007, has been debated extensively: a proposed rule issued in November 2014 received nearly 900 comments from all sectors of the research community, reflecting the serious concerns of investigators, biopharma companies and the public in ensuring broad access to the important health information generated by clinical investigations. Commercial study sponsors have been accused of hiding important research data, particularly for trials that fail to support market approval of a new drug, while academic researchers have appeared highly reluctant to comply with disclosure requirements.
Simple studies & failures
The new rule clarifies that its requirements apply to all interventional studies involving human subjects, including those with only a single group of patients, and not just to “well-controlled studies” with multiple arms. More than 224,000 study records are posted on ClinicalTrials.gov, but results information is posted for only 23,000, according to an article published online Sept. 16, 2016 by the New England Journal of Medicine. This supports the adoption of more stringent policies governing the submission of results for all registered studies, even those that fail to achieve regulatory approval. Access to results information from trials of unapproved products can help investigators assess risks and benefits to future trial participants and improve medical decision making on related products, according to the authors from NIH.
At the same time, the final rule continues to permit delays of up to three years in posting results of completed trials to provide investigators time to publish journal articles and sponsors to submit data to gain FDA approval of a new medical product.
The final rule further requires that results from sponsors include baseline data on patient race and ethnic background, when collected in a clinical trial, plus more specific information on clinical measures, such as blood pressure. It provides tables for reporting serious and “other” adverse events. And a new data entry system for submitting information to ClinicalTrials.gov is slated to be up and running by Jan. 18, 2017, when the rule goes into effect.
FDA retains authority to levy stiff fines of up to $10,000 a day on sponsors that fail to meet the listing and disclosure requirements. So far, the agency has not assessed such penalties, but now may feel more pressure to do so. FDA commissioner Robert Califf said that 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.”
These policies for disclosing clinical trial activity and results are part of a broader NIH effort to improve the quality and efficiency of studies supported by its $3 billion-a-year clinical research program. As described by NIH leaders in another posting by the Journal of the American Medical Association, NIH also plans to expand GCP training for investigators, revise its peer-review and funding processes, reduce inconsistencies in data and protocols submitted to NIH and FDA, and reduce duplicative reviews by Institutional Review Boards.
Article originally published in Pharmaceutical Executive 9/16/16.