RDF19 Poster Detail
|How does ISRCTN help to promote research transparency and reduce research waste?|
Research transparency means that the existence and results of studies should be publicly recorded so that research is not repeated unnecessarily and maximum benefit is gained.
Trial registration is only the first step. If the research is truly transparent, the trial registration record must be accurate, meaningful and kept up to date. In 2018, the World Health Organization (WHO) published updated International Standards for Clinical Trial Registration, which require increased checks on trials and trial registrants.
What should a trial investigator expect when they register a trial with ISRCTN? Under the WHO standards, investigators must provide publicly visible contact details, ideally institutional details, and show copies of documents confirming the details of the trial to the registry. These documents must be from a third party such as an ethics committee, funder or regulatory body. The standards also require full contact details for the ethics committee that approves the study design. ISRCTN records contain a plain English summary so that the trial is accessible to the public. They also record the investigator’s arrangements for sharing the raw data for analysis by other researchers.
Once the trial has been registered, investigators will be expected to keep the record up to date. It is vital to update the study contacts and expected milestone dates so that ISRCTN can send timely reminders. Changes to the interventions, outcome measures and participant inclusion/exclusion criteria should be recorded as soon as they are agreed, so that the trial registration remains an accurate public record.
The research community expects results to be available within one year of trial completion. If the results are not published in a journal, ISRCTN can display a basic results file and links to other publicly available sources, such trial websites, theses and funder reports.