Healthcare leaders spanning the globe urge U.S. presidential hopefuls to back openness on clinical trials
Close to 60 physicians, medical researchers and public-health experts from around the world are imploring American presidential candidates to state whether they support access to all clinical trial data held by U.S. federal agencies—regardless of the trials’ topics, findings, sponsors or geographical settings.
Led by Harvard Medical School’s John Abramson, MD, MSc, and Tom Jefferson, MD, of the Centre for Evidence Based Medicine at the University of Oxford, the group is primarily concerned about drug companies being allowed to publish portions of trial data while withholding the rest.
“Study results posted on clinicaltrials.gov are, by definition, incomplete and unverified,” they write in an open letter posted online in The BMJ. “Physicians and patients require access to clinical study reports and anonymized individual patient data from trials of approved drugs and biologics.”
They further point out that U.S. law and regulations “globally affect organizational and professional behaviors with huge impact on health worldwide. The international composition of this letter's signatories reflect this reality.”
Among the signers is Marcia Angell, MD, a former editor-in-chief of the New England Journal of Medicine.
The letter is brief and to the point. Read the whole thing.