Access to clinical trial information and the stockpiling of Tamiflu - Public Accounts Committee Contents

1  The availability of clinical trial results and the sharing of information between the MHRA and NICE

1.  All new medicines require a licence. UK-only licences are granted by the MHRA. European Union (EU)-wide licences are granted by the European Commission with the licensing process coordinated by the EMA. In England, some medicines are also appraised by NICE to assess the clinical and cost-effectiveness for use in the NHS. Clinical trials on humans are the key source of information used to understand the safety and efficacy of a medicine. The majority of clinical trials are undertaken, or sponsored, by the medicine manufacturer. [3]

2.  On the basis of a Report by the Comptroller and Auditor General, we took evidence from the Department of Health (the Department), the MHRA and NICE on: the availability of clinical trial results; how the MHRA and NICE share information; and on the stockpiling of Tamiflu. We also took evidence from Dr Ben Goldacre and Dr Fiona Godlee, Editor-in-Chief of the British Medical Journal.

3.  Research first highlighted the issue of unpublished clinical trials in 1986.[4] Dr Goldacre noted that an NHS National Institute for Health Research review in 2010 estimated that the chance of completed trials being published is roughly half. Trials with positive results were about twice as likely to be published as trials with negative results. Dr Godlee supported this view, telling us that the pharmaceutical industry published more positive results than negative results from their trials. She noted that the British Medical Journal had published very clear summaries of systematic reviews of data on individual medicines or classes of medicines where, "when you add together the published and unpublished evidence, you get a very different picture of the quality and effectiveness of those drugs."[5]

4.  A number of clinical trial registries have been established including those by the EMA and the National Institutes of Health (NIH) in the USA.[6] The EMA registry contains only those trials conducted in the EU since 2004. The NIH registry, launched in 2000, contains both USA trials and trials conducted outside the USA. However, neither of these registries covers all clinical trials conducted worldwide.[7]

5.  Witnesses agreed that the results of clinical trials should be available for wider scrutiny by medical researchers and clinicians.[8] This would help to scrutinise and support the work done by regulators during the licensing process and allow clinicians to make informed decisions about which treatments are best.[9] In 2012, the EMA announced plans to release clinical trial data pro-actively once the licensing process has been completed. The policy was expected to come into force in January 2014 but has now been delayed—and in any case only covered trials conducted after 2014 so it would therefore do nothing to improve the evidence base for currently used treatments.[10] In 2013, GlaxoSmithKline and Roche announced their commitment to share clinical study reports with personal information removed.[11]The MHRA told us it is "confident" it had access to "all the relevant data" and that, if a company does not provide all the data, the MHRA has enforcement powers to insist on it. The MHRA told us that both at European level and at national level, when the agencies' scientific assessors look at the dossiers that companies bring forward, if there are additional points of information that the agencies require, a list of questions to the applicants goes back and "there is the force of European law transposed into UK law that that data shall be provided". The MHRA told us that this includes data relating to incomplete trials, negative trials, or studies carried out for indications apart from the one for which a licence is being sought, and that "any information that bears on the safety and efficacy of that product has to be made available to the regulator in order to support a marketing authorisation".[12]

6.  Dr Fiona Godlee agreed that the MHRA and the EMA were entitled to all the information but added: "They are entitled to it. They haven't asked for it". Dr Godlee described the regulators as "busy, under-resourced and stretched" and told us: "They tend to take the manufacturers' word for it. It is only when slightly obsessive and very scientifically determined people, like the Cochrane Collaboration and others, actually go in and look under the bonnet, and begin to see that there are not only 15 trials of Tamiflu but 123 trials of Tamiflu, of which 74 are entirely Roche-funded, Roche-controlled - Roche has the data - that you begin to see the madness of this situation: that we are getting a very partial, incomplete, misleading picture of the effectiveness of many drugs."[13] The MHRA considered that there was no legal obstacle preventing it from sharing information with NICE.[14] NICE confirmed that it does not have the same legal powers as European regulators to demand information from manufacturers.[15] However, in Germany, a legal obligation has been placed on manufacturers to provide the Institute for Quality and Efficiency in Healthcare, which performs a similar role to NICE, with a full list of clinical trials and supporting clinical study reports.[16] NICE told us that it seeks confirmation from the medicine manufacturer's UK medical director on the completeness of information submitted for technology appraisals, but accepted that the UK medical director may not be aware of all trials globally.[17] NICE confirmed during the hearing that it would, in future, ask for confirmation that information was complete at a global level although the wording of the new declaration which medical directors are now required to sign still does not require companies to hand over full methods and results on all trials conducted on the treatment being reviewed.[18]

3   'Access to clinical trial information and the stockpiling of Tamiflu', National Audit Office, HC 125 Session 2013-14, May 2013. Back

4   Qq 1-2 Back

5   Qq 1, 9, 10-11; C&AG's Report para 1.3 Back

6   C&AG's Report para 2.7 and 2.13 Back

7   Qq 33-34, 79; C&AG's Report para 2.7 and 2.13 Back

8   Qq 3-9, 12, 31-33, 59, 78-79  Back

9   Qq 4-6, 79, 100 Back

10   Q 64; EMA announcement: Back

11   Q 30 Back

12   Q 50; Roche subsequently announced a new global policy on clinical trials dat,: Back

13   Qq 15-19 Back

14   Qq 58-59, 64 Back

15   Qq 13, 56 Back

16   Q 13; C&AG's Report para 2.17 Back

17   Qq 105-106 Back

18   Q 108 Back

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© Parliamentary copyright 2013
Prepared 3 January 2013