The DHHS is seeking to expand the scope of information on clinical trials that must be submitted to the NIH’s online data set of experiments in the midst of ongoing concerns that too many trial results are withheld.
The DHHS unveiled proposed requirements for its online clinical trials register, ClinicalTrials.gov, which will require pharmaceutical and medical device companies to provide more information about patient enrollment, the progress of trials and the results of those trials – even if a product is never granted approval in the U.S.
The move comes amid ongoing criticism that public health may be harmed due to many trial results remaining concealed. For example, a 2012 study in the BMJ showed that fewer than half of all National Institutes of Health-funded trials were published in peer-reviewed journals within 30 months of completion, with a third of completed trials remaining unpublished after nearly four years.
It has been a heated issue, particularly for the pharmaceutical industry, which has endured scandals as a result of disclosures that trial data containing safety or effectiveness information was not previously disclosed.
Under Section 801 of the Public Health Service Act, as amended by the Food and Drug Administration Amendments Act of 2007, the DHHS was ordered to create a clinical trial registry data bank. That data bank, www.ClinicalTrials.gov, is run by the National Institutes of Health (NIH) National Library of Medicine (NLM). The website works as a unified center for the oversight of clinical trials, and provides information about the sites where a trial is conducted, the general design of a study and information about its sponsor.
The NIH said it hopes the proposed rules will at least double the number of summary results published on the website per week to between 200 and 250. To achieve this, the DHHS is looking to expand the scope of information required to be submitted to cover summary results for products not currently approved or licensed in the U.S., in addition to main results and additional tables presenting breakdowns of adverse events. The regulations also clarify who is responsible for posting data and the timing for providing the information, along with needed updates.
The new proposal calls for multiple changes to how clinical trial results are recorded and reported. For instance, under the proposal, only one entity can be responsible for the submission of information regarding an “applicable clinical trial.” Also, the information provided to ClinicalTrials.gov would need to include information on obtaining “expanded access to investigational drugs used in applicable clinical trials,” but only if those drugs are available through an expanded access program.
The proposed changes are also heavily focused on the submission of results, with the rule proposing to “extend the requirement for results submission to applicable clinical trials of drugs, biological products, and devices that are not approved, licensed, or cleared by FDA.”
Under the proposed rule, companies would be required to submit tables of data that summarize demographics and baseline characteristics of enrolled participants and primary and secondary outcomes. The results would need to be submitted within one year following the completion date of the clinical trial.
Additionally, the rule would require the inclusion of the number of adverse events suffered by patients in the results submitted to the ClinicalTrials.gov register, which, according to RAPS, is unusual given that the FDA already accepts and analyzes much of that information.