Clinical trial transparency is criticised by MPs

A current lack of transparency in clinical trials is “unacceptable”, a cross-party group of MPs has said

September 17, 2013

In a new report the House of Commons science and technology committee says it is “not been impressed” with government efforts to tackle the problem to date.

“Many of the trials taking place today are unregistered and unpublished, meaning that the information that they generate remains invisible to both the scientific community and the public,” said committee chair and Labour MP, Andrew Miller.

“This is unacceptable, undermining public trust, slowing the pace of medical advancement and potentially putting patients at risk.”

In its report, published on 17 September, the committee recommends that all trials conducted on NHS treatments and receiving public funding should be registered in advance and their results published in a scientific journal – even where they are negative.

The report also draws attention to the recent fall in the number of trials taking place in the UK, stating that the UK was a “particularly challenging” place in which to conduct a trial because of the requirement for numerous, and potentially duplicate, governance approvals from participating NHS organisations.

The committee reserves judgement on whether the Health Research Authority, created in 2011 to make it easier to conduct research in the NHS, has so far been successful, but expresses concern that awareness of its role was low.

The HRA said the organisation had already taken steps in many of the areas identified by the committee to improve awareness and promote transparency.

“Last week we announced the first of a series of measures to improve transparency – from 30 September 2013, registration of clinical trials in a publicly accessible database will be a condition of the favourable ethical opinion,” said HRA chairman, Jonathan Montgomery.

Mr Miller added the problems with the UK system were “not insurmountable” and that the committee were confident that the government was aware of the need to resolve them.

The report also recommends that the government takes steps to facilitate greater sharing of the raw data generated during a trial.

“We are not in favour of the uncontrolled release of potentially sensitive patient data, even in anonymised form. However, raw trial data is currently underutilised and could be of significant scientific value if shared in a responsible and controlled way, with the knowledge and consent of patients,” added Mr Miller.

The report also calls on the government to take its recommendations into account in on-going discussions about revising of the European Clinical Trials Directive – which the committee says since 2001 has posed a “significant barrier” to conducting trials in the European Union – as well as in its response to the European Medicines Agency’s consultation on the release of clinical trial data.

Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry, said the sector had already recognised the need for “increased but responsible transparency” and demonstrated its commitment through efforts including revising the ABPI Code of Practice.

“However, research is a truly global activity and requires a consistent global approach. Any UK transparency requirements that sit on top of, and are separate from, European requirements will act as a disincentive for conducting clinical research in the UK,” he added.

elizabeth.gibney@tsleducation.com

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