Transcript of Select Committee evidence on transparency

House of Commons logoThe House of Commons Science & Technology Select Committee has released a draft transcript of the oral evidence given to its inquiry on clinical trials on April 22nd. A video recording of the session is also available. Five members of the committee heard evidence from:

  • 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
  • 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
  • Dr Ben Goldacre, Wellcome Research Fellow in Epidemiology, London School of Hygiene and Tropical Medicine

Among the comments made by the witnesses were the following:

  • We would support a requirement to make the data available on suitable request, provided that request is accompanied by a protocol of what is going to be done with the data, how the analyses are going to be conducted and, very importantly, how those results will subsequently be made public by the people conducting the analyses.” (Professor Peter Johnson)
  • “The philosophy of sharing data is a good one, but one does not want to do that without regard to the overhead and the cost to research funders, because the opportunity costs of that are significant.” (Sharmila Nebhrajani)
  • “Where a CSR has already been produced, we see no reason why it should not be made available, although we would clarify that by saying that, if the EU database is publicly available, we would have to redact any patient-identifiable information, which means that, potentially, you lose some of the value of the CSR in any event. It would introduce a huge additional financial and time burden on non-commercial researchers, so from that perspective we certainly do not agree with that amendment.” (Nicola Perrin)
  • “There are also the concerns that appropriately to anonymise that dataset would take a lot of resource and may not achieve the end of ensuring that there is appropriate privacy. In order to do that, the data may become much less useful for other researchers by the time the measures have been taken to ensure privacy. We think there are better ways to ensure that data is shared between researchers. We mandate that data should be shared from MRC studies, but there may be better ways to do that than releasing datasets in a publicly-available situation, where they have to be very stringently deidentified.” (Dr Catherine Elliott)
  • “…clinical research is not embedded sufficiently as part of the work of NHS trusts in general, although there are increasing signs that it is changing, with the creation of the Academic Health Science Networks and the onus on them to undertake research” (Dr Bina Rawal)
  • “Even if we had complete reporting of all trials starting from today-2013-or from 2008 under the FDA Amendments Act, that still would not improve the evidence base very significantly for medicine today, because about 85% of the medicines prescribed are generic, which means they came on the market more than 10 years ago. We need the results of clinical trials that completed in 2006, 2003, 1999 and 1994 in order to practise medicine safely, because those are the trials that inform the decisions for the treatments we are giving today.” (Dr Ben Goldacre)
  • “… we are trying to go back to the year 2000 from the formation of GSK to make all of those trials available, which will capture many of the clinical trials of our medicines that are on the market today. But, before that, it becomes very difficult when we get into a situation where most of those reports could have been produced by a typewriter on paper. It is very difficult to make those available.” (Dr James Shannon)
  • “We have not yet signed up to AllTrials, but you will find that our policy as written meets all the principles in AllTrials that Dr Goldacre has initiated. We are still working on the roadmap that we want to undertake to implement this. Once we have got through that, and also had discussions at European level-because there is a similar initiative on data transparency at that level-we will be publishing our roadmap.” (William Burns)

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