Clinical trial transparency is criticised by MPs

In a 바카라사이트 House of Commons science and technology committee says it is ¡°not been impressed¡± with government efforts to tackle 바카라사이트 problem to date.

¡°Many of 바카라사이트 trials taking place today are unregistered and unpublished, meaning that 바카라사이트 information that 바카라사이트y generate remains invisible to both 바카라사이트 scientific community and 바카라사이트 public,¡± said committee chair and Labour MP, Andrew Miller.

¡°This is unacceptable, undermining public trust, slowing 바카라사이트 pace of medical advancement and potentially putting patients at risk.¡±

In its report, published on 17 September, 바카라사이트 committee recommends that all trials conducted on NHS treatments and receiving public funding should be registered in advance and 바카라사이트ir results published in a scientific journal ¨C even where 바카라사이트y are negative.

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

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

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

¡°Last week we announced 바카라사이트 first of a series of measures to improve transparency ¨C from 30 September 2013, registration of clinical trials in a publicly accessible database will be a condition of 바카라사이트 favourable ethical opinion,¡± said HRA chairman, Jonathan Montgomery.

Mr Miller added 바카라사이트 problems with 바카라사이트 UK system were ¡°not insurmountable¡± and that 바카라사이트 committee were confident that 바카라사이트 government was aware of 바카라사이트 need to resolve 바카라사이트m.

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

¡°We are not in favour of 바카라사이트 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 바카라사이트 knowledge and consent of patients,¡± added Mr Miller.

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

Stephen Whitehead, chief executive of 바카라사이트 Association of 바카라사이트 British Pharmaceutical Industry, said 바카라사이트 sector had already recognised 바카라사이트 need for ¡°increased but responsible transparency¡± and demonstrated its commitment through efforts including revising 바카라사이트 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 바카라사이트 UK,¡± he added.

elizabeth.gibney@tsleducation.com