Leading doctors and researchers urge presidential candidates to support access to clinical trial data
Last modified: May 21, 2017
Action needed to address scandal of invisible and distorted clinical trials, they argue.
Over 50 leading doctors and researchers across the globe, amongst whom NRIN chair prof. dr. Lex Bouter, are calling on all US presidential candidates to state whether they support access to clinical trial data.
In an open letter to candidates, published by The BMJ, they ask what measures they would put forward, if elected, to address the scandal of invisible and distorted clinical trials.
They believe physicians and patients should have access to clinical trial data to ensure they have complete and accurate information to make treatment decisions.
The letter explains that medical experiments on humans (clinical trials) are carried out in the hope of improving health and furthering science, but “no benefit can be derived from trials which are either invisible or reported partially or selectively.”
To avoid this risk, a growing number of organisations have made efforts to allow access to clinical trial results in a detail hitherto unknown, say the authors. “Despite the growing international effort and a notable legislative effort in the European Union, the US lags behind.”
“Physicians and patients require access to clinical study reports and anonymized individual patient data from trials of approved drugs and biologics.”
They point out that eight years after the introduction of federal law FDAAA 2007, “a very small number of results of registered trials have been made available and updated.” No detailed regulatory documents are available from the FDA, they add.
US law and regulations globally affect organizational and professional behaviours with huge impact on health worldwide, they write. As such, they call for “a statement by all US presidential candidates on whether they support access to clinical trial data held by federal agencies, irrespective of topic, sponsor, country in which the trial was run or results.”