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Lars Hemkens

Dr. med. Lars G. Hemkens, MPH is Senior Scientist at the Basel Institute for Clinical Epidemiology and Biostatistics (ceb), University Hospital Basel. Previously he was at the Stanford Prevention Research Center (Stanford University) and IQWiG (Department of the Director). His key interests include using the best available and unavailable evidence for improving care decisions. His work focuses on routinely collected data, pragmatic trials, evidence synthesis and meta-research.

Routinely collected health data (RCD) for randomised controlled trials (RCT)

09:00 wednesday June 21st

Objectives: Routinely collected data (RCD e.g. administrative claims data, electronic health records and patient registries) can be useful for the conduct of randomised trials. We will outline the opportunities and challenges for the use of RCD, in particular for recruitment of participants and follow-up.

Methods: This interactive workshop invites data scientists, clinical researchers, trial managers, regulators and other interested stakeholders. We will present and discuss empirical research on the validity and reliability of RCD in general and specifically for trial recruitment and follow-up. We will discuss examples from the UK, Switzerland and other countries aiming to interactively outline promises, opportunities and challenges of this way of evidence generation. We aim to develop recommendations for trialists and regulators to make best use of this opportunity.

Results/Conclusions: RCD should be used for more than observational data analyses. Their true value for evidence based health care may be their potential to generate more and more useful randomized evidence by facilitating large-scale pragmatic trials at low cost.

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