One key aspect to the success of the UK Clinical Trials Gateway (UKCTG) launched in March 2011 is the presentation of trial information in a format that can be easily understood by the general public, in the shape of a “lay summary”. This is part of the UK Government’s commitmentin the NHS Constitution to ensure that more trial participants are made aware of research that is of particular relevance to them.
A lay summary is the description of the research question of a trial in laymen’s terms and should aim to answer the following questions:
- Background and study aims
- What does the study involve
- Who can take part
- Where does the study take place
- What are the risks to participants
- Who is funding the project
- Who is the main contact
The UKCTG is run by the NIHR on behalf of all the UK Health Departments and the source of its data includes the ISRCTN trial register managed by Current Controlled Trials, BioMed Central’s sister company.
To prepare for the inclusion of lay summaries in the corresponding trial records, a specific field has been created in the ISRCTN database. As of 7 June 2011, trialists can now provide the text of a lay summary or a link to an existing webpage as part of the submission of trial details. The lay summary information stored in this new field will be passed on to the UKCTG in the coming weeks. ISRCTN will also be working with a number of organizations including CancerHelp UK, the National Research Ethics Service and the Medical Research Council Clinical Trials Unit to ensure that lay summaries that are made visible through the ISRCTN and the UKCTG websites are of the highest quality possible.