US presidential candidates are urged to support open data campaign

Campaigners for clinical trial transparency have written an open letter to all US presidential candidates urging them to declare support for the principles of open access to clinical trial data and to commit to making it a reality in the United States if elected.1

Clinical trials attempt to shed light on the potential harms and benefits of a treatment or a procedure, and their outcomes are never certain. “No benefit can be derived from trials which are either invisible or reported partially or selectively,” said the letter, which has been signed by more than 50 international academics and medical publication editors. “Physicians and patients require access to clinical study reports and anonymized individual patient data from trials of approved drugs and biologics.”

Although a growing number of organisations have made efforts to allow access to clinical trial results and there has been “a notable legislative effort in the EU,” the US lags behind, the letter added. Eight years after the introduction of the Food and Drug Administration Amendments Act (FDAAA) 2007, which requires trials to be registered and results to be reported on ClinicalTrials.gov, only “a very small number of results of registered trials have been made available and updated” in the US, the letter said. Furthermore, no detailed regulatory documents are available from the FDA.

“US law and regulations globally affect organizational and professional behaviors with huge impact on health worldwide,” the authors noted. “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.”

The letter’s signatories included Fiona Godlee, editor in chief of The BMJ; Tom Jefferson, of the Centre for Evidence Based Medicine in Oxford, UK; and Peter Gøtzsche, of the Nordic Cochrane Centre in Copenhagen, Denmark.