Collaborative Challenges of Multi-Cohort Projects in Pharmacogenetics—Why Time Is Essential for Meaningful Collaborations

Abstract

Multi-cohort projects in medicine provide an opportunity to investigate scientific questions beyond the boundaries of a single institution and endeavor to increase the sample size for obtaining more reliable results. However, the complications of these kinds of collaborations arise during management, with many administrative hurdles. Hands-on approaches and lessons learned from previous collaborations provide solutions for optimized collaboration models. Here, we use our experience in running PGX-link, a Swiss multi-cohort project, to show the strategy we used to tackle different challenges from project setup to obtaining the relevant permits, including ethics approval. We set PGX-link in an international context because our struggles were similar to those encountered during the SYNCHROS (SYNergies for Cohorts in Health: integrating the ROle of all Stakeholders) project. We provide ad hoc solutions for cohorts, general project management strategies, and suggestions for unified protocols between cohorts that would ease current management hurdles. Project managers are not necessarily familiar with medical projects, and even if they are, they are not aware of the intricacies behind decision-making and consequently, of the time needed to set up multi-cohort collaborations. This paper is meant to be a brief overview of what we experienced with our multi-cohort project and provides the necessary practices for future managers.

The BioRef Infrastructure, a Framework for Real-Time, Federated, Privacy-Preserving, and Personalized Reference Intervals: Design, Development, and Application

“…As sensitive data themselves are not shared between participating parties, the BioRef approach is compliant with both national and international data provision laws (ie, the European Union’s General Data Protection Regulation [GDPR]) [ 62 ]. Notably, the use of a distributed analytics system as deployed can significantly reduce the governance overhead for future multicohort collaborations [ 36 ]. It will also facilitate obtaining permission from ethical boards, as identifying information is retained only by the respective hospital.…”

“…Despite all the progress achieved by this streamlined infrastructure, the hurdle for nationwide data pooling is still relatively high. A recent effort to establish a Swiss multicohort resource in pharmacogenetics has been documented to take up to a year for just setting up the legal and scientific framework [ 36 ]. Novel privacy-preserving data exchange and data processing options or platforms could alleviate the regulatory burden imposed on multicohort projects.…”

Cohort Profile: Swiss BioRef: The building blocks of a nationwide IT infrastructure in Switzerland for generating precise reference intervals

“…The hurdle for nation-wide data pooling is therefore relatively high. A recent effort of establishing a Swiss multi-cohort resource in pharmacogenetics has been documented to last up to a full year for only setting up the legal and scientific framework [31]. The CA defines that each party hosts their respective laboratory data provided for the project either on the secure IT infrastructure BioMedIT network in a dedicated project space on Leonhard Med (LeoMed) for the purposes of the project or locally by using MedCo, a secure system for privacy-preserving federated analytics based on multiparty homomorphic encryption, where the data stays locally at the particular site of the participating institution and only the aggregated result of the requested computation is released in cleartext to the authorised user [32].…”