From: EFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets – a primer for academic researchers
Communication between data holder and researcher
How to implement / alternatives
Consequences if not possible
While researcher is putting together the research proposal
Researcher fully understanding which data have been collected, study design etc.
Possibility for Researchers to raise questions directly regarding data collected on the data sharing company sites.
Higher number of research proposals needing to be rejected or resubmitted following initial review.
During research to clarify understanding of study’s SAP, dataset specifications
Enable the Researcher to understand data and the analysis already conducted.
Ensure complete documentation is provided by data holder to eliminate this as much as possible
Lack of knowledge of data collected potentially leading to inappropriate analysis.
Sharing the completed analysis, interpretation and proposed publications
Sponsor is aware prior to publication of any difference in interpretation of results
Sponsor requests to be informed up front of publication. The alternative is to take a risk and deal with receiving information in parallel to it being in public domain
Differing results based on analyses of anonymized data could lead to different interpretation and raise either justifiable or unnecessary concerns in scientific and public domains