Open Medicine EU

The issue of open access to data from clinical trials is moving to the fore. Four regulators, from the British, Dutch, French and European medicines agencies, have responded to an earlier paper arguing for open access in PLoS Medicine. This is high level stuff.

The authors reject the notion that clinical trial results could be considered as commercially confidential. They accept the key arguments for open access and point out that access to more data will also help to choose individualised treatments for particular patients. (Successful medicines may work on most patients but rarely on all patients – more data may help to explain why.)

The authors also enter some caveats against open access. One caveat is universally accepted – patient confidentiality must be protected. The second “more contentious” caveat is the danger that the data will be misinterpreted, distorted or misused.

I have no doubt that clinical trial data might be distorted or misused, for example by (some) people who are passionately opposed to vaccination or genetic modification or by (some) advocates of “alternative” medicine, or indeed by (some) competitors but the fear that information might be misused is a catch-all argument against disclosure of any information, and that cannot be right. Disclosure is essential to good science, and good medicine.

The four regulators propose a number of practical steps towards disclosure of clinical trial data. The editor of Prescrire, Christophe Kopp, has described their approach as “paternalistic”. Perhaps, but for me the regulators’ paper moves the discussion from whether to provide open access to how to provide open access to clinical trial data.

Sadly, the fact that four important regulators accept the principle of open access does not necessarily mean that we will see it any time soon. Continuing pressure on the regulators and on DG SANCO is needed to achieve this objective.

Here’s a suggestion. Patients in clinical trials normally sign consent forms, regulated by EU law. Why not include in such forms a binding commitment from the trial sponsor to publish the results of the trial in good time and to provide open access to clinical trial data? Such a requirement could be included in DG SANCO’s forthcoming proposals for revision of the Clinical Trials Directive.

Ethically, sponsors owe no less to trial participants – food for thought for ethics committees.

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