Towards Greater Transparency of Clinical Trials Data

November 23, 2012
Adeline Siew, PhD

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

As an industry that is constantly being scrutinised, pharma is now under pressure to openly publish all data from clinical trials, including negative results such as failures of medicines during phase I–III evaluation.

As an industry that is constantly being scrutinised, pharma is now under pressure to openly publish all data from clinical trials, including negative results such as failures of medicines during phase I–III evaluation. From January onwards, the British Medical Journal (BMJ) will only publish studies on drugs and devices, whether industry funded or not, where there is a commitment to “make the relevant anonymised patient level data available on reasonable request.” The move was fully supported by GlaxoSmithKline (GSK), who is already posting results from all its clinical trials on the company’s website. In a press release, Patrick Vallance, the president of pharmaceuticals R&D at GSK, said, “Moves like this should help medical research by allowing scientists to study the detailed results of clinical trials and increase understanding of current and new medicines.”

GSK’s response is indeed a sharp contrast from Roche. Last month, Dr Fiona Godlee, the editor-in-chief of BMJ, wrote an editorial calling for greater transparency within the pharmaceutical arena, apparently sparked by Roche’s reluctance to disclose complete raw data sets for its influenza drug, Tamiflu (oseltamivir). The data were requested by researchers at Cochrane, who wanted to conduct a meta-analysis on the safety and efficacy of Roche’s antiviral. According to the Swiss drugmaker, the Cochrane group had been provided with 3200 pages of highly detailed information addressing their concerns. Ironically, at least to me, Roche continues to insist that Tamiflu is safe and effective, despite news that it is under investigation by the European Medicines Agency (EMA) for failure to comply with legal obligations to report side effects associated with 19 medicines licensed for use in Europe.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), whilst acknowledging the importance of advancing transparency in clinical research, has however cautioned that this drive for full disclosure of trial data could potentially caused “significant harm to the interests of innovators and individuals if transparency is approached in an indiscriminate way.”

EFPIA said in a statement, “Medicines should benefit patients. We support measures that enhance the way they are used and enable the industry to continue to innovate. These measures include improved transparency. As a global industry, we are focused on working towards responsible transparency, as shown by the commitments already made. Building on these initiatives, we recognise and take seriously our responsibility to lead in advancing transparency, and propose that this needs to be part of a comprehensive initiative involving all stakeholders.” EFPIA further added that apart from personal privacy, commercial confidentiality must be taken into account considering the number of products and new uses that are not protected by patents.

As the debate on open data gathers momentum, we’ll just have to sit back and watch how the industry responds. After all, what has pharma got to hide if our medicines are really as safe and as effective as claimed by these drugmakers who are making millions, if not billions. Surely we have the right to know.

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