UK as first country intending to have 100% of all clinical trials registered and their results reported in the public databse
16-09-2020 / Daniela van 't Ent - Ifrim / Legislation
UK’s Health Research Authority new initiative is to reach 100% of clinical trials registration, including CT results, into the public database. This is in order to offer transparency regarding clinical trials and facilitate information sharing among the researchers.
- is based on the four elements of research transparency (registering research, reporting results, informing participants, sharing data and tissue).
- covers all interventional clinical trials (e.g. trials with medicinal drugs, medical devices, surgical technique, public health measures as well as behavioral therapies).
- the Health Research Authority will directly register clinical trials based on data submitted during the ethics approval process.
- all clinical trials will be expected to report their results within 12 months.
- sponsors and researchers of clinical trials will have to keep their study information up to date in registries.
- HRA will regularly publish monitoring data enabling the public to see which pharmaceutical companies, universities, NHS Trusts and medical research charities are making results public.
- starting with 2021 HRA will “introduce research transparency performance assessment into review of new studies”. Hence, who fail to meet transparency expectations may be refused ethics approval for future studies.
For a PDF version of this strategy, click here.