Bridging trials and RWD: Navigating translation
We are happy to introduce a blog series written by REDDIE consortium members under "REDDIE Insights". REDDIE insights will dive deeper into the project-related topics and bring them closer to the general audience, explaining our research at REDDIE.
REDDIE - Real-world evidence for decisions in diabetes is an EU-funded initiative that aims to explore how real-world data can complement randomised controlled trials to improve the efficacy, safety, and value for money of technologies to prevent and treat diabetes.
The first REDDIE insight is written by Kathrine Kold Sørensen, a Postdoc at the University of Copenhagen / Nordsjællands Hospital who is part of the WP4 - Validating RWE against RCT evidence team.
In Work Package 4, we explore the process of connecting outcomes from controlled clinical trials with real-world evidence. This journey involves navigating through various stages, including employing complex statistical methodologies.
The initial necessary step involves identifying a study population that mirrors the characteristics of patients included in the original trial. However, it is essential to recognize that the trial's patient inclusion process may differ significantly. For instance, in the trial setting, patients' medical histories can be meticulously examined through face-to-face interactions.
In our efforts to replicate a similar patient population using Danish registries, a pragmatic approach becomes imperative. The Danish registries were primarily designed for quality control and administrative purposes rather than research. Therefore, translating trial inclusion criteria requires adaptability.
Take, for example, the inclusion criterion of "type 2 diabetes." Relying solely on hospital diagnosis codes may prove insufficient, as not all diabetic patients have hospital interactions. Hence, a pragmatic alternative, such as tracking the prescription of glucose-lowering medications may provide a more comprehensive representation. In Denmark, tracking prescriptions is possible through the National Prescription Database, and Figure 1 provides an overview of several other registries that are available. More information about the Danish registries e.g., is available here: Health registries as research tools: a review of methodological key issues.
Each inclusion and exclusion criterion requires careful evaluation and transparent communication. This ensures reproducibility in subsequent publications, aligning with the principles of academic integrity.
Bridging the gap between controlled trials and observational data demands a nuanced approach, particularly when translating inclusion criteria. By embracing pragmatism and maintaining transparency, we uphold the standards of scientific rigor essential for meaningful research.
Figure 1: Overview of some of Danish registries
Source:https://sundhedsdatastyrelsen.dk/da/english/health_data_and_registers/national_health_registers