Speakers at the meeting include those who had already sought out practical methods for preparing data and governance frameworks, or had at least estimated the resources needed to do this. Catrin Tudor Smith of the North West Hub for Trials Methodology Research in the Department of Biostatistics at the University of Liverpool presented on how patient or participant data (IPD) from publically funded trials should be shared, based on her 2015 paper. The paper sets out basic uk rcs data requirements for how to share a trials dataset. She further highlighted the results from a 2014 survey of IPD reviewers, who felt that a central repository for storing IPD would be valuable. Tudor Smith and Nevitt presented their 2017 work on resource implications of preparing data from two UK publicly funded clinical trials (the SANAD trial with over 2000 participants with epilepsy recruited from 90 hospital outpatient clinic; and the MENDS trial with 146 children with neurodevelopmental problems recruited from 18 hospitals).
These practical approaches demonstrate that it is, unsurprisingly, very close to the methodology for preparing and publishing cohort study data; in effect clinical trials are a narrowly focused longitudinal study, with clinical measures and limited phenotypic data, but with far less social data, as context.
The Cochrane connection
In the autumn of 2018, Nancy Medley, a researcher affiliated with the Harris Wellbeing Preterm Birth Centre at the University of Liverpool and with Cochrane Pregnancy & Childbirth, made contact with Louise to discuss data sharing and how the UK Data Service operated as a data curator, publisher and access point.