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A study and new index shows that only 65% of clinical trials are being registered and reported on. Nearly half of the new drugs approved by FDA in 2012 had one Phase II or III trial that was not disclosed. Regulatory ambiguities, mergers, and lack of enforcement action may be to blame
Using a Transparency Index developed by Bioethics International (which launched its Integrity Scorecard in 2009), a new study published Nov. 12, 2015 in BMJ Open suggests that Big Pharma is not meeting legal and ethical standards for disclosing and reporting on clinical trials. Companies are legally required to disclose trial results. This transparency is important, not only in the public's trust of the industry, but also in helping health care providers determine the best medical treatment and resolve prescription issues.
However, only two-thirds of clinical trials for drugs that FDA approved in 2012 were disclosed, the study found. The paper, written by Dr. Jennifer Miller of NYU Langone Medical Center, who heads up Bioethics International, and researchers from Harvard Medical School and Yale School of Medicine and affiliate agencies, analyzed trial disclosure and reporting for the 15 drugs-developed by 10 companies-that FDA approved in 2012. Only two of the 10 companies reviewed met with all legal disclosure and reporting requirements, the researchers found.
Per drug, a median of 57% trials were registered, the authors found. For 20% of the drugs, results were reported on ClinicalTrials.gov, 56% were published and 65% were either published or reported on. Almost half of all reviewed drugs had at least one Phase II or III trial that was not disclosed. A median of 17% of trials supporting FDA approvals met with FDA Amendments Act (FDAAA) clinical trial regulations.
The authors discussed findings with representatives from the companies ranked in their report, and suggest that, in some cases, noncompliance stems from ambiguities in FDAAA regulations. Some individuals believe the requirements only apply to controlled trials, while others see them as covering interventional trials only.
Another factor playing a major role is the impact of pharma mergers and acquisitions, of which there have been a record number over the past few years, and licensing agreements. In some cases, the authors write, there are questions about who is responsible for ensuring that trials comply with regulations.
Another dampening effect that the authors note is the perception that regulations are not being enforced. In theory, FDA can impose a $10,000-day fine for noncompliance, but it has yet to use this authority.
The authors also call upon a higher authority: Ethics standards-as found in the Common Rule and Helsinki Declaration-state that research involving human beings should contribute to generalizeable knowledge and be publicly accessible.
The authors speculate that companies may not be acting because there is no single organization promoting a unified policy on clinical trial disclosure and reporting. “Perhaps the new WHO guidelines calling for all trial results to be publicly disclosed, including phase I trials, may serve this purpose,” they write. They plan to continue monitoring transparency of clinical trials and to publish updates annually.
Source: BMJ Open