Call for health professionals involved in the management of patient registries or patient cohorts in Belgium to participate in an exploratory phase preparing for KCE Trials funded Registry-based RCTs (R-RCTs)
What are R-RCTs ?
Registry-based Randomized Controlled Trials (R-RCTs) are clinical trials that utilize existing patient registries for participant selection, data collection, and outcome tracking. Randomization can be included within the registry or can be performed outside. These registries, which gather real-world data from broad (real-life) patient populations, make it possible to conduct trials more efficiently and affordably than traditional RCTs. Advantages and challenges of R-RCTs have been summarized in a recent systematic review (Trials 2024).
Trial Within Cohorts (TwiCs) is a type of study design in which a randomized controlled trial (RCT) is embedded within a larger observational cohort. It differs from R-RCTs mainly by the consent procedure (in R-RCTs, all patients need to consent while in TwiCs the control group is usually not informed of the randomization). Both designs are eligible in this exploratory phase.
Why is KCE Trials performing an exploratory phase on R-RCTs ?
KCE Trials is exploring the possibility to organise R-RCTs in Belgium. This exploratory phase aims to assess the readiness of selected Belgian health registries for R-RCTs by evaluating their technical capabilities, data quality, infrastructure, and governance. If positive, the findings will guide KCE Trials in writing and publishing a future call for funding R-RCTs, laying the groundwork for successful R-RCT implementation in Belgium.
KCE Trials is thus asking healthcare professionals who are in charge of patient registries in Belgium and who are willing to explore the possibility to conduct a R-RCT to contact us. The idea is to organise a short online meeting to present the register and to discuss potential research questions. Randomization can be performed outside of the registry. Please note that there is no possibility of funding associated with this exploratory phase. If positive, KCE Trials may later open a specific call for proposals on R-RCTs and TwiCs.
To ensure suitability for this exploratory phase, registries must meet the following criteria:
- Disease-specific or condition-specific clinical registry: The registry should be specific to a disease area or to a condition and must include detailed patient characteristics, regular follow-up information, and robust clinical outcome data.
- Geographic coverage: The registry should include participants in all three regions of Belgium—Flanders, Wallonia, and Brussels—ensuring comprehensive representation of the patient population and clinical practices across the country.
- Data quality validation: The registry must have established processes for data quality validation, including regular audits or validation checks to confirm data accuracy, completeness, and consistency.
Interested in this exploratory phase ? What are next steps ?
If you are the healthcare professional involved in the management of the clinical registry, please send a mail to KCE Trials (trials@kce.fgov.be) with the following information:
- The name and ID of your registry in the healthdata database (Search - FAIR.healthdata.be) + relevant publicly available documentation
- Briefly describe how the registry meets the three criteria presented above
- if you already have some research ideas, please mention the PICOs (they should be in scope of KCE Trials programme, i.e. comparative effectiveness and non-commercial)
A member of KCE Trials will then contact you to organize an online meeting to have more information (after a short assessment of the suitability of the registry for the exploratory phase).
This exploratory phase will be organised in Q1-Q2 2025.
There is no possibility of funding associated with this exploratory phase.
