Identification of COVID-19 clinical studies intending to share individual participant data for secondary use: Protocol for a pilot study

Within the BY-COVID project (https://by-covid.org/), a pilot study will be performed to evaluate a simple classification system for data sharing statements of registered clinical studies, characterising the degree of willingness for data sharing, initially and specifically within COVID-19 studies. The evaluation will be performed by 3 experts on a random sample of 200 studies with a data sharing statement in a trial registry, extracted using a search of the metadata repository (MDR, https://crmdr.org/) of ECRIN. The bilateral inter-observer variability between experts will be investigated. In case of disagreement between experts a consensus will be derived to serve as the ‘source of truth’ (so called “gold standard”) for further investigations exploring the use of semi-automatic classification algorithms. Subsequent to the data sharing statement categorisation, the intention is to contact the sponsors and / or principal investigators of those trials that appear likely to provide individual participant data (IPD) and ask whether they would be willing to share IPD in the context of the BY-COVID project.