Thursday, November 12, 2015

An open letter to all US Presidential candidates on clinical trial transparency

In the BMJ:

Medical experiments on humans (clinical trials) are carried out in the hope of improving health and furthering science. By their very nature they entail uncertainty about potential harms and benefits of a treatment or a procedure. This is why following WWII, prior ethics review by an independent committee has gradually been introduced as a key condition.

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.

Despite the growing international effort and a notable legislative effort in the EU, the US lags behind.

Study results posted on clinicaltrials.gov are, by definition, incomplete and unverified. Even so, 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. Physicians and patients require access to clinical study reports and anonymized individual patient data from trials of approved drugs and biologics.

US 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.

We 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.

We ask that they state what measures they would put forward, if elected, to address the scandal of invisible and distorted clinical trials.

Corresponding authors:

Dr John Abramson
Dr Tom Jefferson

The full list of signatories (including me) is here. 

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