Here you can browse the report together with the Proceedings of the Committee. The published report was ordered by the House of Commons to be printed 9 September 2013.
Terms of Reference
Summary
1 Introduction
2 Regulation and governance of UK trials
What are clinical trials?
Regulatory and governing bodies for UK trials
The European Clinical Trials Directive
3 Barriers to conducting trials in the UK
Introduction
European barriers to conducting a clinical trial
The Clinical Trials Directive
The proposed Clinical Trials Regulation
UK barriers to conducting a clinical trial
Regulatory and governance complexity
NHS research and development approval
Monitoring NHS Trust performance
Patient recruitment
The Clinical Trials Gateway
4 Clinical trial transparency
The need for trial transparency
The four levels of clinical trial transparency
Level 1: Trial registration
Level 2: Summary-level trial results
Level 3: Clinical study reports
Level 4: Individual patient-level data
Past initiatives to increase clinical trial transparency
The EU Clinical Trials Register and ClinicalTrials.gov
Public and charitable grant requirements
The International Committee of Medical Journal Editors
Current initiatives to increase clinical trial transparency
The EU Clinical Trials Regulation
The European Medicines Agency
The Health Research Authority
Industry-led initiatives
The AllTrials campaign
Value-based pricing and the renegotiation of the PPRS
Incorporating emerging evidence into clinical practice
5 Conclusions
Conclusions and recommendations
Formal Minutes
Witnesses
List of printed written evidence
List of additional written evidence
List of Reports from the Committee during the current Parliament
Oral and written evidence
Wednesday 13 March 2013: Professor Sir Michael Rawlins, Chair of the Academy of Medical Sciences Working Group on the Regulation and Governance of Health Research, Dr Keith Bragman, President of the Faculty of Pharmaceutical Medicine, and Dr Fiona Godlee, Editor in Chief of the British Medical Journal
Monday 22 April 2013: Dr Catherine Elliott, Director, Clinical Research Interests, Medical Research Council, Sharmila Nebhrajani, Chief Executive, Association of Medical Research Charities, Professor Peter Johnson, Chief Clinician, Cancer Research UK, and Nicola Perrin, Head of Policy, Wellcome Trust; Dr Bina Rawal, Director of Research, Medical and Innovation, Association of the British Pharmaceutical Industry, Dr James Shannon, Chief Medical Officer, GlaxoSmithKline, William M Burns, Member of the Board of Directors, Hoffmann-La Roche, and Dr Ben Goldacre, Wellcome Research Fellow in Epidemiology, London School of Hygiene and Tropical Medicine
Wednesday 15 May 2013: Simon Denegri, NIHR National Director for Public Participation and Engagement in Research and Chair, INVOLVE, and Professor Karol Sikora, Medical Director of Cancer Partners UK and Dean, University of Buckingham Medical School; Tracey Brown, Managing Director, Sense About Science, and Dr Helen Jamison, Deputy Director, Science Media Centre; Bill Davidson, Acting Deputy Director and Head of Research Standards and Support, Department of Health, Peter Knight, Deputy Director, Head of Research Information and Intelligence, Department of Health, Dr Janet Wisely, Chief Executive, Health Research Authority, and Sir Kent Woods, Chief Executive, Medicines and Healthcare Products Regulatory Agency
Monday 3 June 2013: Rt Hon David Willetts MP, Minister of State for Universities and Science, Department for Business, Innovation and Skills, and Rt Hon Earl Howe, Parliamentary Under-Secretary of State for Quality, Department of Health
Written evidence
Additional written evidence
