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US law insufficiently observed in clinical research

US law insufficiently observed in clinical research

There is a large variation in the amount of legally required information pharmaceutical companies supply in clinical drug research. That is the conclusion of research conducted by the New York University Langone Medical Center, written in BMJ Open.

The public availability of clinical trial information has been insufficient for decades and the consequences are far-reaching. “Selectively disclosing trial information can distort medical evidence. It makes it a challenge to provide the right drug for the right patient”, says Jennifer Miller, PhD, main author and assistant professor of medical ethics at New York University. She also says selectively disclosing information violates the rights of human research subjects.

Miller and colleagues researched the publicly accessible information of fifteen drugs, approved by the FDA in 2012. The researchers collected clinical trial information of the drugs sponsored by ten pharmaceutical companies at Drugs@FDA, and MEDLINE. They counted more than 318 clinical trials, accounting for 99,599 human research subjects. For nearly half of the assessed drugs, the authors found no publicly accessible information concerning a phase II or III trial. Furthermore, only 57 percent of clinical trials was properly registered, twenty percent of results was reported on Only 65 percent had their results reported.

The authors write that this is the first research denouncing the legal and ethical obligations concerning the public accessibility of clinical trial information. Based on the results they conclude that the law is not enforced in this area. The researchers therefore propose an annual scoring system, designed for stimulating pharmaceutical companies to improve their behaviours.

Source: BMJ Open

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