Background: Transparency and access to research data is a key feature for research policies, leading to optimal use of data generated by research projects. Access to individual-participant data (IPD) could improve data quality, accuracy of estimates, and robustness of analyses, as well as optimise data re-analyses and pooling. Numerous organisations have endorsed the need to provide the scientific community with access to IPD and currently several initiatives aim to develop best practice on sharing and re-using this data. To be effective, these standards should consider the opinions, attitudes and perceptions of citizens, patients and their associations. Country-specific analyses may highlight cultural and social factors that could play a role in facilitating data sharing.
Objectives: To explore opinions, attitudes and perceptions of Italian patient and citizen associations about sharing of IPD from clinical research.
Methods: An online survey will be sent to about 2000 Italian patient and citizen associations included in a database kept updated at the Mario Negri Institute. These associations are active at the local, regional and national level, cover a broad spectrum of disease areas and have different expertise in clinical research promotion, lobbying activities, and support to patients and families.
Associations will be sent an introduction text and be invited to complete an online survey structured in two main areas: association’s characteristics - e.g. activities, funding sources, size - and attitude and perceptions on sharing IPD from clinical research - e.g. knowledge of the discussions on data sharing, official positions of the association, perceived risks and advantages of sharing, suggestions to implement best practice in terms of access model, informed consent, transparency of processes. Responses will be analysed and possible drivers of positive attitudes or reluctances explored.
Results: The introduction text and survey are currently under testing by a sample of patient representatives with the goal of launching the survey in May. We aim to present the results at the Summit, provide feedback to associations, and publish them.