What are clinical trials?
- NHS: http://www.nhs.uk/Conditions/Clinical-trials/Pages/Definition.aspx
- MHRA: https://www.gov.uk/government/collections/clinical-trials-for-medicines
Guidelines for study registration and reporting
- WHO: http://www.who.int/ictrp/trial_reg/en/
- ICMJE: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
- Declaration of Helsinki: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research- involving-human-subjects/
- CONSORT: http://www.consort-statement.org/
- SPIRIT: http://www.spirit-statement.org/
Other public registries and portals
- WHO trial search portal: http://apps.who.int/trialsearch
- Be Part of Research: https://bepartofresearch.nihr.ac.uk/
Legislation around clinical trials
- USA: https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm
- EU: http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm
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:
- The Department of Health and Social Care - via the NIHR Clinical Research Network (CRN) Portfolio - funds the registration of all non-commercial studies, with an interventional component.
- The Wellcome Trust - see its Funding for clinical trials Policy.
- The Medical Research Council (MRC) - more on its policy.
ISRCTN works to streamline trial registration processes with the following organisations:
- The National Institute for Health Research through the NIHR Central Portfolio Management System (CPMS) - 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 registration.
- The Health Research Authority and its partners through the Integrated Research Application System - IRAS is a centralised system that helps researchers apply for permissions and approvals for health and social care research in the UK.
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.
- Association of Medical Research Charities - has 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.
- Be Part of Research - ISRCTN data uploaded weekly. Be Part of Research aims to list trials that have recruited and are recruiting in the UK and help the UK 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 trial registries through its participation in the WHO Working Group on Best Practice for Clinical Trials Registers, in particular:
- ClinicalTrials.gov - this is the US-based trial registry whose UK trials are also pooled in Be Part of Research.
- The European Union Clinical Trials Register (EUCTR) - this is the publicly available side of the European Union Drug Regulating Authorities Clinical Trials (EudraCT) database resulting from European Commission legislation.