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18 April 2013 House of Commons Science and technology Committee Clinical trials Written evidence 18 April 2013 List of written evidence 1 Department of Health 2 Michael Power 3 Global Alliance of Publication Professionals 4 Cochrane NI Review Group 5 Margaret McCartney 6 Andrew Russell and John Hughes 7 London School of Hygiene & Tropical Medicine 8 Stephen Senn 9 Christopher Roy-Toole 10 The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust 11 Dr Elizabeth Wager 12 Sir Iain Chalmers 13 Sir Alasdair Breckenridge 14 Privacy International and MedConfidential 15 Trial Steering Committee 16 Co-convenors of Cochrane Collaboration Individual Participant Data Meta-analysis Methods Group 17 Professor Sir John Bell FRS, FMedSci 18 Centre for Evidence-Based Medicine, University of Oxford 19 Medical Schools Council and Association of UK University Hospitals 20 Sense About Science 21 PLOS 22 Parkinson's UK 23 Glyn Moody 24 BMJ 25 Cardiff University School of Medicine & Cardiff and Vale University Health Board 26 The Migraine Trust 27 NETSCC 28 NHS European Office 29 BioIndustry Association (BIA) 30 General Medical Council 31 COPE 32 British Heart Foundation 33 The Academy of Medical Sciences 34 King's Health Partners 35 BioMed Central and Current Controlled Trials Ltd 36 HSUK & HAI Europe 37 UKCRC Registered CTU Network 38 UK Research Integrity Office 39 Ethical Medicines Industry Group 40 Dr Mark Edwards 41 National Institute for Health and Clinical Excellence 42 Roche 43 PatientsLikeMe UK 44 PharmAware 45 Cancer Research UK 46 Association of Medical Research Charities (AMRC) 47 Faculty of Pharmaceutical Medicine 48 Association of the British Pharmaceutical Industry (ABPI) 49 The Cochrane Collaboration and the Centre for Reviews and Dissemination 50 Health Research Authority 51 INVOLVE 52 Clinical Contract Research Association (CCRA) 53 The Royal Society 54 Medical Research Council 55 Dr Ben Goldacre 56 Wellcome Trust 57 Royal College of Physicians 58 GlaxoSmithKline 59 Royal Pharmaceutical Society and the National Pharmacy Clinical Trials Advisory Group (NPCTAG 60 Christopher Roy-Toole Written evidence submitted by the Department of Health (CT00) INTRODUCTION 1. The Government ensures the safety of patients in clinical trials via the regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – and Health Research Authority (HRA) while providing national infrastructure through the NHS to encourage clinical trials to be conducted in the UK. 2. Clinical trials required to test new medicines are regulated by MHRA. Regulation is governed by the EU Clinical Trial Directive which has been transposed into UK law. 3. The following evidence addresses the matters set out in the inquiry’s terms of reference. Do the European Commission’s proposed revisions to the Clinical Trials Directive address the main barriers to conducting clinical trials in the UK and EU? 4. In recent years we have seen a decline in clinical trial activity in the EU. The number of clinical trials conducted in the EU fell by 25 percent between 2007 and 2011. In the UK, the number of trials fell by 22 percent over the same period. This decline cannot solely be attributed to the Clinical Trials Directive1: an independent review by the Academy of Medical Sciences of the regulation and governance of health research found that ‘the governance arrangements within NHS Trusts are the single greatest barrier to health research’2, which the Government is addressing through initiatives of its National Institute for Health Research (NIHR)3. However, the current legislation has had an effect on the cost and feasibility of conducting clinical trials and the complexity of the regulatory framework has been cited as a barrier. 5. The European Commission’s proposal for a Clinical Trials Regulation was adopted on 17 July 2012. The Commission’s stated aim in publishing the proposal was to boost clinical research in Europe by simplifying the rules for conducting clinical trials. 6. The Government welcomes much of what is included in the European Commission’s proposal for a Clinical Trials Regulation. We consider that the proposal has the potential to create a more favourable environment for the conduct of clinical trials in the EU, by making it easier to conduct trials in multiple Member States and introducing a proportionate and risk- adapted approach to clinical trials. 7. There are several elements that the Government is particularly pleased to see included in the proposal, including: • the introduction of risk-adapted regulation of clinical trials, including the introduction of the concept of low-intervention studies, the streamlining and simplifying of the safety reporting requirements and the adoption of a proportionate monitoring approach; 1 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use" 2 Academy of Medical Sciences. A new pathway for the regulation and governance of health research. Jan 2011. http://www.acmedsci.ac.uk/p47prid88.html 3 National Institute for Health Research. Faster, easier clinical research. http://www.nihr.ac.uk/systems/Pages/faster_easier_clinical_research.aspx • the introduction of one application for multi-state clinical trials replacing individual applications in different Member States which we believe has the potential to decrease the burden on researchers and promote the conduct of clinical trials in the EU (although we will be looking to improve the efficiency of the process); and • the concept of one single submission and one single decision replacing the current separate regulatory approval and approval by Ethics Committees. This concept is introduced for both single and multi state trials. 8. There are, however, aspects of the proposal that the Government has concerns over. For example, we will be examining in more detail the proposal to oblige Member States to set up a national indemnification mechanism that, on a not-for-profit basis, provides insurance cover for all clinical trials conducted in the UK, giving sponsors the choice between private insurance and a Government scheme. 9. As regards disclosure of clinical trials data, the Government fully supports the Commission’s ambition to increase transparency and views positively the elements of the proposal designed to do this, including through ensuring that the EU database should be publicly accessible and that there should be a presumption that the summary of the results of clinical trials be made available to the public through this database. The Government is considering whether further measures could be included in the Regulation to increase transparency. What is the role of the Health Research Authority (HRA) in relation to clinical trials and how effective has it been to date? 10. The Health Research Authority (HRA) was established on 1 December 2011 as a Special Health Authority. The overarching purpose of the HRA is to protect and promote the interests of patients and the public in health research. The HRA protects patients from unethical research while enabling patients to benefit from research by simplifying processes for ethical research. 11. Through the National Research Ethics Service (NRES), the HRA provides for the ethical review of health research proposals including clinical trials, to protect the rights, safety, dignity and wellbeing of research participants and potential participants. The HRA also acts as a member of the UK Ethics Committee Authority (UKECA) by agreement with the four nations. UKECA has responsibilities for establishing, recognising and monitoring ethics committees that give an opinion on the ethics of research under the Medicines for Human Use (Clinical Trials) Regulations 2004. 12. The HRA is simplifying processes for research through cooperation with other bodies such as the MHRA to create a unified approval process for research approvals and to promote consistent and proportionate standards for compliance and inspection. 13. From 1 April 2013, the HRA will be taking on further functions relating to approving the processing of confidential patient information. The Government intends to legislate to establish the HRA as a non-departmental public body when parliamentary time allows, and clauses in the draft Care and Support Bill for this purpose have been published for pre- legislative scrutiny. 14. The Government is committed to transparency and the publication of research findings is a high priority area for the HRA. Ethics committee review already asks whether research will be registered on a public database, and how researchers intend to report and disseminate the results of that research. The decision by an ethics committee to give a favourable opinion includes consideration of these plans. 15. A summary of the final report on the research should be submitted to the main research ethics committee within one year of the conclusion of the research. The HRA also publishes research summaries of approved studies on its website to promote transparency in research, to encourage registration and publication and to provide a simple website publication of research approved by NRES in the UK. 16. The HRA intends to follow up on applicant-declared intentions to register and publish trial results. It intends to monitor compliance, to identify researchers, funders and institutions that are not
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