Workstream 4 - Pragmatic Trials and Real-World Evidence

Translation of innovation to research and care is RC2NB’s mission. This workstream provides the framework to systematically evaluate patient-relevant benefits resulting from therapeutic and diagnostic innovations developed at RC2NB.

We take advantage of the unique combination of interdisciplinary clinical and methodological expertise at RC2NB with long-standing experience in clinical trial design and conduct, established and novel data infrastructures, and support and collaboration through a wide network of stakeholders locally, nationally and internationally.

We aim to create a learning system that combines high-quality real-world data with randomization integrated into usual care to continuously evaluate health care decisions in pragmatic trials. This yields high-quality evidence on patient-relevant benefits and accelerates the implementation of diagnostic and therapeutic innovation to real-world care settings.

We use data collected from routine care and data on digital, imaging and fluid biomarkers. We leverage complex high-quality data from the SMSC, an established nationwide cohort study, and aim to integrate approaches allowing decentralized, remote trials in an effort to minimize research burden for investigational teams and, most importantly, for patients.

We rely on state-of-the-art clinical epidemiology and meta-research methods to continuously develop, evaluate, and optimize this real-world evidence-generating system to inform care decisions.

Core Members

PD Dr. med. Lars G. Hemkens MPH
Prof. Dr. med. Dr. phil. Jens Kuhle
PD Dr. med. Özgür Yaldizli

Swiss MS Cohort

  • One of the worldwide largest comprehensive MS cohort studies including eight Swiss MS centers
  • Clinical, imaging and biofluid data of highest quality and standardization
  • >1500 patients, > 11000 visits, > 5.9 years follow-up


  • Personalized medicine in MULTIple SClerosis, a pRagmatIc Platform Trial embedded within SMSC
  • A trial platform that continuously evaluates novel personalised treatments for multiple sclerosis (MS) compared to usual care
  • Nationwide Investigator initiated clinical trial supported by the Swiss National Science Foundation

Hemkens Lab

  • The team works at the intersection of clinical research, evidence-based-medicine, and digital health
  • We explore and develop new methods and study designs to optimally integrate research in routine health care to generate high-quality patient-oriented evidence with a strong focus on pragmatic trials and routinely collected data
  • We aim to provide the conceptual and methodological foundations for pragmatic trials as randomized real-world evidence
  • With PragMetawe provide the first systematic large-scale empirical meta-epidemiological analysis of determinants of pragmatism, funded by the Swiss National Science Foundation
  • PragMeta is conducted in collaboration with a large network of international pragmatic trial experts to reflect most recent conceptual developments and ensure that results optimally translate into future clinical research