The National Research Ethics Service (NRES), the umbrella body for ethics committees in the National Health Service (NHS), has announced a collaborative project aimed at improving the public transparency of clinical trials in the UK.

The NRES is working with the James Lind Alliance and the Department of Health to reconcile the Service’s Research Ethics Database (RED) with two existing publicly accessible clinical trial registers, ClinicalTrials.gov and the International Standard Randomised Controlled Trial Number (ISRCTN) Register.

The initiative is expected to be completed by the end of this year. The first step was to integrate ISRCTN registrations with the RED. The goal was to ensure that ISRCTN records for CTIMP (Clinical Trials of an Investigational Medicinal Product) studies were up to date by the end of February.

The project team will then contact the chief investigators of trials for which no registration number is held. It aims to complete the NRES dataset before the matching process starts with the other two registers.

Formally launched in May 2003 as “the first online service that provides unique numbers to randomised controlled trials in all areas of healthcare and from all countries around the world”, the ISRCTN scheme is designed to simplify trial identification through a numeric system that can be used to track all publications and reports related to a particular study.

The register is owned by ISRCTN, a not-for-profit organisation with directors from, among others, Cancer Research UK, the US-based Robert Wood Johnson Foundation and the UK’s Department of Health (DoH).

It has the following member organisations: the DoH, the Canadian Institutes of Health Research, the Mario Negri Institute for Pharmacological Research in Italy, the Medical Research Council (UK) and the Netherlands Organisation for Health Research & Development. The scheme is administered on ISRCTN’s behalf by Current Controlled Trials Ltd.

Disclosure debate
According to the NRES, completing the reconciliation project will make the UK one of only two countries to have achieved this level of public transparency in clinical trial registration (the other being Italy).

Nor was the Service shy about linking the initiative to the disclosure debate sparked last week by the Medicines and Healthcare products Regulatory Agency’s (MHRA) decision not to proceed with a criminal prosecution of GlaxoSmithKline for allegedly sitting on data about suicide risks associated with Seroxat (paroxetine) in the under-18s.

“Recent publicity about drug safety and the importance of openness highlights the need for all involved in research – industry, academia, researchers, regulators and reviewers – to work together and place as much data as possible in the public domain,” the NRES stated. “The National Research Ethics Service believes this is a common moral duty.”

Sir Iain Chalmers, editor of the James Lind Library and chair of the advisory group for the UK Clinical Trials Gateway (a dataset of trials conducted in the UK and registered with a ISRCTN identifier), suggested the current performance of some researchers in this respect was tantamount to scientific and ethical misconduct.

“Having a public database where all UK clinical trials are registered will reduce biased under-reporting of clinical trials,” he commented. “Under-reporting can result in avoidable dangers to patients.”

He pointed to the US, where the Food and Drug Administration Amendments Act of 2007, signed into law by President George Bush last September, requires sponsors to lodge details of all “controlled clinical investigations”, other than Phase I studies, of compounds subject to the Federal Food, Drug, and Cosmetic Act in ClinicalTrials.gov, the existing on-line registry run by the National Institutes of Health.

Previously, only federally and privately funded studies of experimental treatments for “serious or life-threatening diseases and conditions” had to be included, while registration of any other trials was voluntary.

Sir Iain regards the NRES’ Research Ethics Database as a “gold standard” for clinical trial datasets. The system, which has been in use since 2004, handles all ethics applications for clinical research in the NHS. It allows the administrators to manage every part of the application process and provides the NRES with valuable information to ensure compliance with both UK law and the relevant European Union directives.

The NRES was launched in April 2007 as a rebranded version of the UK’s Central Office for Research Ethics Committees (COREC), operating (as before) within the National Patient Safety Agency.