PragmaTrial®
Hippocrates Research’s Dedicated Business Unit for Pragmatic Studies
PragmaTrial® was established in response to the growing complexity and evolving demands of modern clinical research.
Through their methodology and application, pragmatic studies play a key role in generating Real-World Evidence (RWE) by bridging the gap between traditional randomized controlled trials (RCTs) and real-life clinical practice. This approach overcomes several limitations of purely observational studies, producing more reliable, interpretable, and operationally efficient evidence, which is increasingly essential for regulatory and healthcare decision-making.
The recent update of the ICH Good Clinical Practice (GCP) guideline and the introduction of Annex 2 mark a true paradigm shift in clinical research, moving away from prescriptive rules toward a risk-based, flexible framework that fosters innovation and better aligns clinical research with the needs of patients, healthcare systems, and future beneficiaries.
What is a Pragmatic Study?
A pragmatic study is an experimental study and, more specifically, a randomized controlled trial (RCT) designed to evaluate the effectiveness of a treatment. Characterized by high external validity, pragmatic studies are recognized as a robust source of Real-World Evidence.
In contrast, traditional RCTs primarily focus on internal validity, aiming to demonstrate efficacy under controlled conditions for hypothesis testing. Pragmatic studies, typically conducted in an open-label setting, provide a more comprehensive understanding of how a treatment performs in real-world clinical practice, beyond the constraints of experimental environments.
What is the purpose of a Pragmatic Study?
The primary objective of a pragmatic study is to evaluate the real-world effectiveness of a treatment through comparative effectiveness research, or to assess product safety, either during the marketing authorization phase or in the post-marketing setting.
This approach enables the inclusion of broader and more representative patient populations, reflecting real clinical practice. Pragmatic studies assess meaningful outcomes such as remission, recovery, and survival through direct comparison with the standard of care, while also incorporating outcome measures relevant to patients, payers, and decision makers, including pharmacoeconomic evaluations.
Pragmatism as a Modular Approach
Pragmatism is not a rigid concept; rather, it is a flexible and adaptable framework tailored to the specific objectives of each study.
A pragmatic study design may incorporate pragmatic elements—such as broad eligibility criteria—while maintaining explanatory components where needed, including closer monitoring of treatment adherence. This modular design allows studies to:
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Balance internal and external validity in a targeted and intentional way
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Preserve scientific rigor in critical areas while maximizing generalizability
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Optimize resources by focusing efforts where they add the greatest value
Pragmatism should therefore be viewed as a strategic tool, not a constraint, enabling the design of studies that are both scientifically robust and clinically meaningful.
Our multidisciplinary team
PragmaTrial® is supported by a multidisciplinary team that brings together expertise from Medical Affairs, Clinical Operations, Quality Management, Regulatory Compliance, Market Advisory, and Real-World Evidence.
This core team is complemented by a structured network of General Practitioners (GPs) and Primary Care Pediatricians (PCPs), qualified to conduct Phase III and IV studies, as well as dedicated professionals ensuring data quality and operational excellence throughout the study lifecycle.
A MORE FLEXIBLE AND PATIENT-CENTERED APPROACH COMPARED TO TRADITIONAL RCTs
SUPPORTS FASTER TIME-TO-MARKET AND PRODUCT ACCESSIBILITY
DELIVERS STRONGER, MORE ACTIONABLE EVIDENCE THAN OBSERVATIONAL STUDIES ALONE