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What are clinical trials?
Guidelines for study registration and reporting
Other public registries and portals
Legislation around clinical trials

ISRCTN works with a number of stakeholders to improve the information publicly available about clinical trials.

ISRCTN supports open access to clinical trial data information in line with:
  • World Health Organization guidelines - registration of all interventional trials is considered to be a scientific, ethical and moral responsibility.
  • ICMJE statements - for a manuscript to be considered, trial details should be deposited before recruitment starts.
  • Industry recommendations - trial information should be deposited within 21 days of recruitment starting and results be made available within one year of market authorisation.
ISRCTN helps ensure that a number of organisations meet their trial registration objectives:
ISRCTN works to streamline trial registration processes with the following organisations:
  • The National Institute for Health Research through the NIHR Portfolio Database - adoption by the Portfolio ensures that trials can benefit from NHS support and the Portfolio sends trial data batches on behalf of researchers who have opted for ISRCTN public registration.
  • The Health Research Authority and its partners through the Integrated Research Application System - IRAS is a centralised system that help researchers apply for permissions and approvals for health and social care / community care research in the UK. Improved guidance regarding plain English summaries will ensure that researchers produce material once that can then be re-used at different stages, including ISRCTN trial registration.
ISRCTN engages with the following organisations to make sure that current and future participants are better informed about relevant trials:
  • INVOLVE - advises on how to increase participants' involvement in research through better written documents.
  • Association of Medical Research Charities - have reported on challenges to communicate existence and results of research in plain English.
ISRCTN maximises the visibility of its clinical trial data by feeding it to other web platforms:
  • WHO clinical trial search portal - ISRCTN data uploaded weekly.
  • UK Clinical Trials Gateway - ISRCTN data uploaded daily. The UKCTG aims to list trials that have recruited and are recruiting in the UK and helps the Government meet its commitment in the NHS Constitution that patients should be made aware of research relevant to them.
ISRCTN follows the development of all publicly available registers through its participation in the WHO Working Group on Best Practice for Clinical Trials Registers, in particular:
  • Clinical Trials.gov - this is the US-based trial register whose UK trials are also pooled in the UK Clinical Trials Gateway.
  • The European Trials Register - this is the publicly available side of the European Union Drug Regulating Authorities Clinical Trials Database EudraCT database resulting from European legislation.