Q&As regarding trial registration in the UK

3 April 2007

1.  What is the definition of trial registration?

It is the public declaration of the existence of a piece of research in an online searchable and cost-effective database.

When results of a study are published, articles should quote the initial trial registration ID and this would allow readers to go back to the original description of the research.

Drug-based trials are declared to regulatory bodies such as the UK's Medicines and Healthcare products Regulatory Agency and reported to the European Medicines Agency’s EudraCT which is a confidential database held for drug licensing purposes.

There is growing acceptance within the pharmaceutical industry and elsewhere that drug-based trials should also be registered on public websites, usually once a drug has been licensed. Public registration websites also bring non-drug based trials to a wider audience.

The World Health Organisation has proposed the adoption of international guidelines (http://www.who.int/ictrp/data_set/en/index1.html) including 20 standard data items to define a study for full registration. The British Government recognises that there may be commercial reasons for delaying open access to some of the information expected for full registration.

2.  Where should NHS Trusts and UK organisations publicly register their trials in 2007?

The Clinical Trials Tool Kit on http://www.ct-toolkit.ac.uk/route_maps/stations.cfm?current_station_id=299&view_type=map recommends that all UK trials be registered and refers investigators to the ISRCTN register. The ISRCTN is one of a number of registers worldwide that accept registrations on the basis recommended by the WHO, and issue a unique registration ID.

3.  What is the relationship between the Department of Health and CCT?

Since 2003, on behalf of the DH, CCT has been registering HTA funded trials and trials for which all costs have been met by NHS Trusts. Those own account trials are collated in the NHS Clinical Trials Register (see http://www.nrr.nhs.uk/NHSTrustsRegisterKeyPoints.htm).

The source of the data is the National Research Register (NRR). The HTA trials Register, the Time Limited National trials Register, the Regional trials Register and the own account NHS Clinical Trials Register are hosted on CCT's metaRegister on http://www.controlled-trials.com/mrct/, along with the registers of trials funded by the Medical Research Council and the Welcome Trust.

4.  The NRR is scheduled to be decommissioned by the end of 2007 - what is the impact on CCT's work?

The Department of Health has announced its intention to integrate the functions of the National Research Register (NRR) into the United Kingdom Clinical Research Network's (UKCRN) portfolio database (full announcement on http://www.nrr.nhs.uk/NRRSubmissions2007.pdf).

Issue 4, 2007 will be the last data collection round conducted by the NRR before its functions are integrated into the UKCRN portfolio database. Transition funding is taking place in 2007 and it is expected that there will still be a number of own account trials to register. CCT's work for the 2007 update of the NHS Clinical Trials Register is anticipated to start in late Spring 2007.

5.  What will happen in 2008?

From 2008 onwards, it is anticipated that the Department of Health will no longer expect NHS Trusts to report trials to the NRR. The Department of Health’s National Institute for Health Research will expect registration of any trial that is:

• Funded or commissioned by one of the NIHR funding streams or by NIHR partners and
• Adopted by the UKCRN.

Registration will become the responsibility of each trialist. It is anticipated that the DH will make clear for which trials they will pay the registration fee. In the longer term, the NIHR will explore how to build a facility for automatic trial registration into its information systems.

6.  What are the current funding streams?

As indicated on http://www.nihr.ac.uk/programmes_research_programmes.aspx, the National Institute for Health Research Central Commissioning Facility currently commissions research for the following Department of Health programmes:

• Research for Patient Benefit (RfPB)
• The Policy Research Programme (PRP)
• Programme grants for applied research
• Biomedical research centres
• The NEAT Programme (NEAT)
• Invention for Innovation

A number of the NIHR research programmes are not administered by the central commissioning facility including:

• Health Technology Assessment (HTA)
• Service Delivery and Organisation (SDO)
• Research Capacity Development (RCD)
• Health Technology Devices (HTD)
• NIHR Partners

7.  Does 'adoption' by the UKRCN mean 'registration'?

No.  The UKCRN portfolio database currently lists the trials 'adopted' and supported by the UKCRN. The number is expected to grow during 2007 with the establishment of the comprehensive research network and the expansion of the eight topic-specific networks (see http://www.ukcrn.org.uk/index/networks.html). Research support funding will increasingly be channelled through these networks as the Department of Health decreases the amount of R&D support funding (now called 'transition funding') given directly to Trusts and not associated with NIHR centres, programmes, projects and faculty members.

The UKCRN Portfolio Database is capable of handling the 20 data items for 'registration'. However, UKCRN 'adoption' will not equate to 'registration' as defined by the WHO/ICMJE guidelines (with a view to publishing research results). An additional step is required to register a trial. This is because the UKCRN is not likely to 'adopt' all trials conducted in the UK.

8.  If a trial is adopted by the UKCRN, are there arrangements in place to ensure automatic registration?

At present, there are no arrangements for automatic registration, by automatic feeds into the ISRCTN system for example. Responsibility will initially rest with researchers and their sponsors. In the longer term, for the trials it adopts, the NIHR will explore the possibility of a routine procedure to confirm the sponsor’s permission for automatic registration before commencement, using information the lead investigator has already entered into the NIHR information systems.

9.  Are all regions of the UK covered/to be covered by the agreement between the Department of Health and CCT?

The current agreement relates to the NHS in England. The ISRCTN Register is available for the registration of trials in any part of the world, and some trials carried out in Wales, Scotland and Northern Ireland have been registered individually.