Best-Practices to Manage Large Swiss Multi-Cohort Projects in Medicine – Why Meaningful Collaborations Take Time (Preprint)

UNSTRUCTURED Multi-cohort projects are increasingly important in medicine as they provide the opportunity to increase data readiness, i.e. join data and efforts in order e.g. to increase sample size and investigate questions beyond the scope of a single institution. However, multi-cohort projects are also challenging as different cohorts have specific purposes, focus areas, and policies as well as their own established methods of managing, collecting and sharing data. A big challenge is also to already test timely overarching scientific questions in an early convergence phase of different cohorts or registries due to the heterogeneity of patient populations between cohorts caused by the intrinsically different subjects of the different cohorts. Although being complex, multi-cohort projects encourage cross-boundary collaborations and synergies between cohorts by providing staff and funding to homogenize and standardize the current heterogeneous multi-cohort environment for joint endeavors. We show the PGX-link project as a case study to demonstrate the complexity of setting up a two-year multi-cohort project in pharmacogenetics. The project is a feasibility study, focused on building an infrastructure to connect clinical and pharmacogenomics data between three nationally-operating Swiss cohorts: the Swiss HIV Cohort Study (SHCS), the Swiss Transplant Cohort Study (STCS), and the Swiss Clinical Quality Management in rheumatic disease (SCQM). The project infrastructure is funded by the Swiss National Science Foundation (SNSF) in the BioLink program fostering collaborations between cohorts and their biobanks, while the laboratory work and genetic analyses are funded by the Bern Centre for Precision Medicine (BCPM). We show the evolution of the study protocol for PGX-link from the original SNF grant proposal to the submission to the ethics committee and acceptance by the cohorts’ Scientific Boards (SBs). We highlight obstacles we encountered in setting up and managing PGX-link as an inter-cohort collaboration, we explain in detail the changes in the proposal necessary for obtaining the project approval by the ethics committee (EC), and we provide suggestions and potential solutions that improve and support such processes for future multi-cohort projects and likewise serve as a guidance for funding agencies.