Clinical Trials Transparency

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For some time now, there have been strident calls for the publishing of all clinical trial data. The pressure has arisen due to revelations that companies may have hidden crucial clinical data that might have shown that the drug being tested was not as efficacious or even as safe as they appeared from quoted trial results (see, for instance, a previous blog here). The campaign group AllTrials has brought together several people and groups (including for example David Tovey, editor The Cochrane Library; Ben Goldacre (book Bad Pharma); Carl Heneghan, Centre for Evidence-Based Medicine, University of Oxford) because, as they put it:

Around half of all clinical trials have not been published; some trials have not even been registered. If action is not taken urgently, information on what was done and what was found in trials could be lost forever, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated unnecessarily.

Key publications like the British Medical Journal and research bodies such as the Medical Research Council and the Wellcome Trust agree, the trust encouraging its grant recipients to release their trial data.

The European Medicines Agency (“EMA”) has been looking at this for some time, with the same aim in mind and is trying to develop a workable policy to enable the data to be published. Indeed it is thought that in the next few weeks, major players in the United Kingdom’s medical community will meet to try and take things further in a more practical manner.

Some companies for example GlaxoSmithKline (GSK) have agreed to share data with scientists and yesterday (April 4, 2013), Roche agreed to provide Cochrane Collaboration researchers with access to all 74 Roche-sponsored trials related to Tamiflu® (oseltamivi).

However, not all agree. The Association of the British Pharmaceutical Industry (“ABPI”), while supporting transparency, has concerns about patient confidentiality (a concern shared by all), and has said:

[T]he release of commercially confidential information could undermine investment in the research and development of future medicines. This is ultimately not in the interests of patients, who would not be well served by dis-incentivising research based biopharmaceutical companies and commercial organisations from other life sciences sectors from making the substantial investments and shouldering the risks that are necessary to develop new innovative medicines.

The campaign by AllTrials responded to the ABPI, arguing:

[T]he development of new treatments, patient confidence and regulatory oversight can only benefit from having full information about the trials that have been done before and what they have found. It is important that industry engages with this issue. We are not campaigning on access to individual patient data; that is a separate issue.

Indeed, two companies have actually taken legal action against the EMA regarding clinical data transparency. Cases T-29/13, T-44/13 (AbbVie v. EMA) and T-73/13 (InterMune v EMA), regarding the disclosure of clinical trial data, which were submitted as part of a marketing authorization application, under access to document legislation (Regulation (EC) No 1049/2001). UCB, a Belgian drug company, sought information under a Freedom of Information request on AbbVie’s Humira® (adalimumab). AbbVie filed legal actions seeking to protect AbbVie’s “fundamental right to the protection of confidential commercial information.” AbbVie’s Transparency Policy on Clinical Research says “AbbVie is committed to transparency regarding the clinical trials we sponsor and recognizes there are important health benefits in making clinical information available to health care providers, patients, and the general public.” Yet, it appears AbbVie is concerned that the EMA could disclose what AbbVie views as its confidential commercial information to would-be competitors that would not contribute to the scientific review or evaluation of their products.

Presumably the “commercially confidential information” cannot be with respect to how the trials are conducted? It is more likely the concerns are linked to the outcomes and the interpretation of these outcomes and the potential for the generation of new intellectual property or of further leads to new discoveries. However, it would seem there could be a way of creating a balance such that the innovator has the chance to take potential advantage of any new discoveries/leads without protecting the data and thus removing third parties’ abilities to offer their valuable insight and input into the efficacy and safety of the new medicine.