Chris Seeks Location Of Public Registers For Sponsors Of Vaccine Clinical Trials
Christopher Chope Conservative, Christchurch
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 7 November 2022 to Question 73786 on Coronavirus: Vaccination, where the public registers are at which trial sponsors of covid-19 booster vaccines registered their clinical trials; and if he will make it his policy that summary results are published within 28 days of the conclusion of each trial .
Neil O'Brien The Parliamentary Under-Secretary for Health and Social Care
The Medicines and Healthcare products Regulatory Agency (MHRA) instructed sponsors of COVID-19 trials to register studies in a World Health Organization (WHO) compliant public register. The MHRA also provided guidance that, as requested by the WHO, the official acronym COVID-19 is entered in the trial registration data set to facilitate finding and extracting clinical trials related to COVID-19. The relevant public registers are ISRCTN and ClinicalTrials.gov and for trials in European Union states, EudraCT or the Clinical Trials Information System.
Good practice guidance states that summary results should be published in the applicable register in 12 months following the end of the study. While there are no plans for a policy where summary results are published within 28 days of the conclusion of each trial, timely and rapid publication is encouraged.
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