Clinical trials in the UK are regulated by the Clinical Trials Directive which was transposed into UK law by the Medicines for Human Use (Clinical Trials) Regulations 2004. 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.
Transparency and disclosure of clinical trial data have been topical recently, in part due to the recently published book Bad Pharma, by Dr Ben Goldacre. It highlighted 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.
Terms of Reference
The Committee seeks written submissions on the following matters:
1. 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?
2. What is the role of the Health Research Authority (HRA) in relation to clinical trials and how effective has it been to date?
3. What evidence is there that pharmaceutical companies withhold clinical trial data and what impact does this have on public health?
4. How could the occurrence and results of clinical trials be made more open to scrutiny? Who should be responsible?
5. Can lessons about transparency and disclosure of clinical data be learned from other countries?
Submitting written evidence
As part of a scheme to promote paperless working and maximise efficiency, the Committee is encouraging written submissions for this inquiry to be sent by email to firstname.lastname@example.org and marked 'Clinical Trials'.
The Committee invites written submissions on these issues by noon on Friday 22 February 2013.
Each submission should:
a) be no more than 3,000 words in length
b) be in Word format with as little use of colour or logos as possible
c) have numbered paragraphs
d) include a declaration of interests.
If you need to send a paper copy please send it to:
Science and Technology Committee
House of Commons
London SW1P 3JA
Please note that:
• Material already published elsewhere should not form the basis of a submission, but may be referred to within a proposed memorandum, in which case a hard copy of the published work should be included.
• Memoranda submitted must be kept confidential until published by the Committee, unless publication by the person or organisation submitting it is specifically authorised.
• Once submitted, evidence is the property of the Committee. The Committee normally, though not always, chooses to make public the written evidence it receives, by publishing it on the internet (where it will be searchable), by printing it or by making it available through the Parliamentary Archives. If there is any information you believe to be sensitive you should highlight it and explain what harm you believe would result from its disclosure. The Committee will take this into account in deciding whether to publish or further disclose the evidence.
• Select Committees are unable to investigate individual cases.