All trials must be registered from end of September
Clinical trials must be registered in a publicly accessible database from 30 September 2013, as part of the Health Research Authority’s commitment to promote transparency and improve patient and public confidence in health research.
According to the HRA, registration is a condition of favourable ethical opinion, with failure to do so being a breach of good research practice that will be dealt with through standard operating procedures for research ethics committees.
The studies for which registration is initially mandated include: clinical trials of an investigational medicinal product; clinical investigations of a medical device; combined trials of an investigational medicinal product and an investigational medical device; and other clinical trials of a novel intervention or randomised clinical trials to compare interventions in clinical practice.
The HRA expects all studies to be registered before the first patient is recruited and, while a sponsor can contest the need for registration, it says it “does not expect exceptions to be made”.
Janet Wisely, chief executive of HRA, said: “We are fully committed to the principles of transparency in health research. Including a requirement for registration as a condition of the favourable ethical opinion is a significant step towards this.”
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11125683
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