Transfer of the Pragmatic Evidence Lab

The Pragmatic Evidence Lab Team

Transfer of the Pragmatic Evidence Lab to the
Department of Clinical Research

New Academic Director of Clinical Trials

Prof. Dr. Lars Hemkens joined the Department of Clinical Research as Academic Director of Clinical Trials. He aims to improve health care decisions through pragmatic trials and by embedding research into routine care using routinely collected data.

An internationally recognized expert in trial methodology, real-world evidence, digital biomarkers, clinical epidemiology and meta-research, Prof. Hemkens designs and leads clinical trials across a broad range of medical disciplines. His research emphasizes innovative study designs that generate robust randomized real-world evidence and accelerate the translation of research findings into clinical practice.

Transfer of the Pragmatic Evidence Lab

In 2025, the Pragmatic Evidence Lab was integrated into the DCR under the leadership of Prof. Dr. Lars Hemkens (Head) and Dr. Perrine Janiaud (Deputy Head). Closely aligned with the mission of the Department of Clinical Research to shape the future of clinical research and generate evidence that matters, the Pragmatic Evidence Lab advances innovative clinical trial methodologies and rigorous evidence synthesis.

Through this work, the lab aims to improve how clinical evidence is generated, interpreted, and translated into meaningful health care decisions, ultimately supporting better outcomes for patients and health systems.

A Selection of Published Papers
by the Pragmatic Evidence Lab Team

01 SELECTED PAPER

Agreement of treatment effects

in decentralized trials versus traditional trials:

meta-epidemiological study

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Do remote or home-based drug trials give different answers than traditional trials where participants have to visit a research site?

Decentralized trials are rapidly becoming a practical reality, prompting us to examine whether they yield different results than traditional site-based studies.
In an analysis from the Pragmatic Evidence Lab, published in The BMJ, comparing 51 decentralized and 86 traditional trials across 11 clinical questions assessing drug intervention, findss no systematic differences in treatment effects but may modestly deviate (median 1.3-fold; summary ratio of odds ratios 1.01, 95% CI 0.93–1.09).

Notably, decentralized trials were larger (median 1,175 vs 236 participants) and had lower attrition (9% vs 14%), highlighting their potential to reduce participant burden, improve access, and support more patient-centered research while maintaining reliability.

“Moving trials closer to patients doesn’t fundamentally change the answers we get—but it does change how we generate them. That creates real opportunities for more accessible research, while making it essential to better understand how design choices shape the evidence.” – Dr. Perrine Janiaud

02 SELECTED PAPER

Colchicine for the secondary prevention of cardiovascular events

Common gout drug linked to reduced risk of heart attacks and strokes

A new Cochrane review led by the Pragmatic Evidence Lab provides evidence that the inexpensive anti-inflammatory drug colchicine can reduce the risk of recurrent cardiovascular events in high-risk patients. Synthesizing data from 12 randomized controlled trials involving nearly 23,000 participants with established cardiovascular disease, the analysis found that low-dose colchicine (0.5 mg daily) taken for at least six months significantly lowers the incidence of myocardial infarction and stroke without increasing serious adverse events, although mild and transient gastrointestinal side effects were more common. While no meaningful effects were observed on overall or cardiovascular mortality, the findings highlight chronic inflammation as a modifiable driver of cardiovascular risk and demonstrate the potential of repurposing established, low-cost therapies through independent academic research.

“These results come from publicly funded trials repurposing a very old, low-cost drug for an entirely new use it shows the power of academic research to reveal treatment opportunities that traditional drug development often overlooks.” – Prof. Lars Hemkens

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03 SELECTED PAPER

Single-Arm Trials Can Provide Randomized Real-World Evidence: The Random Invitation Single-Arm Trial DesigN

The Pragmatic Evidence Lab introduces a transformative approach to single-arm clinical trials

In this research paper, the Pragmatic Evidence Lab conceptualizes the Random Invitation Single-Arm Trial (RISAT), an enhanced design that addresses key limitations of traditional single-arm trials. By embedding trials in real-world data systems and randomly inviting participants, RISAT improves generalizability, enables fairer access to interventions, and can generate randomized real-world evidence. With minimal additional cost, this approach strengthens early-phase research and supports more robust health care decision making.

“By embedding the trial in real-world data systems as Inselspital’s Epic and randomly inviting participants, we should use RISAT as the standard, replacing conventional single-arm trials wherever feasible, to make health research fairer, more accessible, and maximally useful for patient care.” – Prof. Lars Hemkens & Dr. Perrine Janiaud