Science and Technology Committee: Clinical Trials

The Science and Technology Committee held its second evidence session in its inquiry into ‘Clinical trials’ on Monday 22nd April, commencing at 5:15pm. In December 2011, the Health Research Authority was created to protect and promote the interests of patients and the public in health research. In July 2012, the European Commission produced proposals to revise the Clinical Trials Directive. A recent publication by Dr Ben Goldacre – who gave evidence – claimed that pharmaceutical companies are entitled to conduct numerous clinical trials on a new drug but publish selectively, thus skewing the evidence base available for doctors and patients seeking to make informed decisions. The Inquiry commenced in December 2012 and is due to publish its recommendations during the summer, 2013.

Evidence session
Membership of the Science and Technology Committee: Andrew Miller (Chair)* Jim Dowd Stephen Metcalfe* David Morris* Stephen Mosley* Pamela Nash *denotes present MPs heard from representatives from, amongst others, the Association of the British Pharmaceutical Industry, GlaxoSmithKline (GSK), Roche and the London School of Hygiene and Tropical Medicine. Both representatives from Roche and GlaxoSmithKline told the Committee they are willing to share “raw data” on the results of drug tests on individual patients, provided that it is made anonymous and channelled to authorised researchers. But reiterated that the main focus of transparency should be on providing summary results of trials rather than the underlying raw patient data, which they say could threaten patient confidentiality. They added that reanalysing underlying clinical data Labour Labour Conservative Conservative Conservative Labour Sarah Newton Graham Stringer David Tredinnick* Hywel Williams Roger Williams* Conservative Labour Conservative Plaid Cymru Liberal Democrats

would be second-guessing regulators and could, if poorly conducted, create unnecessary public health scares over drugs. Dr Goldacre highlighted that other drug companies, through research for his publication, remained concerned about the European Medicines Agency’s plans to release all information on drug applications after a decision on approval is made. He offered the example of AbbVie and InterMune, two American companies, who are suing the agency to prevent public release of this data, arguing that it would undermine their competitive advantage. Dr James Shannon, Chief Medical Officer at GSK, said that he fully supports steps to drive greater transparency of clinical trial data, and to help medical research by allowing scientists to study the detailed results of clinical trials and increase understanding of current and new medicines. Ultimately, he added, this should improve patient care. GSK recognises that there are concerns about the extent to which all clinical trials, both industry and academic trials, are published and whether published information accurately reflects the conduct of the study. Sharmila Nebhrajani, Chief Executive, Association of Medical Research Charities (AMRC), told the earlier Select Committee that Directive 2001/20/EC governing clinical trials is widely considered by the industry to have placed barriers to the conduct of clinical trials in the UK and across Europe, including introducing delays in trial setup due to inconsistent implementation of the Directive by Member States, increased bureaucracy and inflexible regulation. AMRC supports a joint statement from non-commercial and commercial organisations welcoming the proposals for the introduction of a new Regulation to replace the 2001 Directive (linked to above). The AMRC had surveyed its members that are funding clinical research (41, in total), either individually or in collaboration with industry, other charities or public funders. 80% of respondents include a requirement in their terms and conditions that the results of the research they fund should be published. Many also request that published research be made “open access” (free to view) on sites such as Europe PubMed Central. Dr Bina Rawal, Director of Research, Association of the British Pharmaceutical Industry (ABPI), noted that the ABPI is undertaking its own research to ascertain the extent to which pharmaceutical companies publish the results of clinical trials sponsored by them, irrespective of prevailing requirements. Whilst the research is still on-going it currently suggests that clinical trials conducted prior to the existence of mandatory requirements or industry guidelines were less likely to be posted on registries or to be published individually; this was particularly the case for smaller, early phase trials. In addition, problems commonly arose where products changed ownership after licensing deals or company mergers and acquisitions.

Ends – Daniel Gooch Associate Director Political Intelligence T: 0203 397 33 00 E:

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