STRATA trial receives ethical approval using new fast track pilot scheme
Doug Webb (Trial Manager)
Medications are often prescribed for autistic adults to reduce their anxiety, but their effectiveness or side effects in this population are not well known. STRATA (SerTRaline for AnxieTy in adults with a diagnosis of Autism. A randomised controlled trial) is an international study being conducted in the UK and Australia. The study aims to determine the effectiveness of sertraline, an antidepressant that is also used to treat anxiety, in reducing symptoms of anxiety and improving quality of life in adults with a diagnosis of autism. You can find out more about the study on the website which is www.bristol.ac.uk/strata
The UK component of our international study was eligible for the new HRA fast-track ethical review pilot scheme, which launched at the beginning of January 2021. We submitted our application (all eighty documents worth!), took a deep breath and crossed our fingers. Our meeting with the Research Ethics Committee took place a week later via video-call. The Committee especially welcomed the attendance of a member of our autistic patient advisory group. It took only three weeks to get approval, including the time for us to respond to the Committee’s comments; all in all, a very quick and positive experience.
The study is sponsored by University of Bristol (UK) and The University of Western Australia (UWA) (Australia).
This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (Reference 127337). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
The authors and University of Western Australia acknowledge funding from the National Health and Medical Research Council (NHMRC) (Project Grant 1171206). The contents of the published material are solely the responsibility of the authors and do not reflect the views of NHMRC.