Ithaka Life Sciences - Blog

Ithaka Life Sciences Ltd (Ithaka) is a provider of business advisory and interim management services to the life sciences sector.

Tuesday, 23 July 2013

Sharing clinical trials data


GlaxoSmithKline (GSK), the world's fourth largest drug company, has recently committed to share all Clinical Study Reports going back to the foundation of the company, as part of the AllTrials campaign (www.alltrials.net). This significant break with traditional pharmaceutical industry practice has come about partly as a result of pressure from regulatory authorities such as the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA). For example, the EMA wants to publish all of the clinical study reports that companies have filed, and the new clinical trials directive could force drug companies to publish all clinical trial results in a public database.

GSK also hopes that sharing these data with researchers will help to further scientific research, increase understanding of new and current medicines and ultimately improve patient care. A recent review of medical research estimated that only half of all clinical trials were published in full, and that positive results were twice as likely to be published as negative ones.

However, not all of the pharmaceutical industry shares GSK’s views. In April this year the EMA was ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court. These interim rulings were made as part of court cases brought by two pharmaceutical companies, AbbVie and InterMune. The companies are challenging the Agency’s decisions to grant access to non-clinical and clinical information (including clinical-study reports) submitted by companies as part of marketing-authorisation applications in accordance with its 2010 access-to-documents policy.

Pharmaceutical industry trade groups, such as the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), are also resisting moves to compel sharing of all clinical trial results. A recently leaked memo indicates that PhRMA and EFPIA have mobilised an army of patient groups to lobby against plans to force publication of all clinical trial results.

The industry groups’ concerns relate to issues such as publishing the information could reveal trade secrets, put patient privacy at risk, and be distorted by scientists' own conflicts of interest. While many of the concerns are valid, it’s fair to say that they can be addressed, and that openness is far more important for patient safety

It is interesting to observe the pharmaceutical industry polarising between more enlightened companies such as GSK (leaving aside the company’s current problems in China) and the more traditional views of companies such as AbbVie and InterMune. There are echoes here of previous events where the pharmaceutical industry has got itself on the wrong side of an ethical debate and generated a lot of bad press for itself.  For example, a decade or so ago we saw pharmaceutical companies apparently threatening to use their patents to prevent HIV patients in Africa and Asia from receiving low cost versions of their drugs. The industry eventually woke up to the implications of what it was doing and now has active programmes to ensure that patients in emerging markets can get access to the drugs they need.

It would be a shame if the industry failed to follow the lead of GSK in adopting an enlightened attitude to the sharing of clinical trials data. In the long run, failure to do so can only cause enormous damage to public perceptions of pharmaceutical companies.

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