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The Transparency of Clinical Trials

An article in the current issue of Science examines the extent to which new policies regarding the governance of clinical trials promote transparency. It goes on to suggest further issues that remain unaddressed and require attention. The authors suggest that recent policy changes have improved the extent of public access to clinical trial data. In particular, they suggest that Section 801 of the FDA Amendments Act “should go a long way in ensuring that all patients and all data are publicly accounted for.” However, with the Editor-in-Chief of the New England Journal of Medicine, they do worry that some patients “are left on the cutting room floor to make a drug look better than it really is.”

It is surely right that researchers and pharmaceutical companies should, insofar as they can, ensure that research participants and drug users base their decisions to participate or take the drug on the best and most complete information available. In many cases this will involve the disclosure of information about previous and on-going trials involving the particular drug in question including, where appropriate, results and serious adverse events.

However it is important to be clear about those to whom these obligations are owed. In the case of on-going clinical trials, the obligation of disclosure is to the trial participants not to the general public. In the case of approved drugs and those that are on already on the market, the obligation to disclose is to those who might consider using the drug.

In each case we should also consider the best means of disclosure consistent with the other obligations of the researcher and the pharmaceutical company. In the latter case — approved and marketed drugs — it seems likely that this may be close to public disclosure. However, in the former case, where the details of the trial are more likely to be commercially sensitive and the relevant population known, public disclosure looks excessive. What matters in the research case is that the very specific group of people who are deciding whether to participate get the relevant information for their decision. This does not necessarily involve the public.

It is easy to forget that the pharmaceutical industry, in addition to seemingly being profitable, brings with it benefits that are important to protect. This fact may in certain cases give us good reason to look for means, other than full public disclosure, of ensuring that the appropriate information is disclosed.

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