April 17, 2018Heart
Registry-based randomised clinical trial: efficient evaluation of generic pharmacotherapies in the contemporary era
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Key result
Registry-based randomised clinical trials leverage existing quality registries to conduct large-scale, pragmatic trials, potentially reducing costs by up to 90% compared to traditional RCTs.
Design
Review
Authors
Discussion
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Implication
Supports efficient large-scale trials via registries; leaves open validation of data integrity and regulatory fit.
PICO
P
Population
Cardiovascular disease
I
Intervention / Comparator
Registry-based randomised clinical trial (RRCT) design vs Traditional randomized clinical trial
Registry-based randomized clinical trials offer a cost-effective, pragmatic approach to re-evaluate established generic cardiovascular therapies by leveraging existing high-quality national registries.
Limitations
- A precondition to perform a RRCT is the existence of a quality registry covering the population to be studied.
- The quality of data in a RRCT is bound by the quality of the data in the register.
- Lack of structured follow-up for safety issues and potential for crossover between arms.
- Risk of type II error if chosen endpoints are not readily sampled by the register.
- Lack of endpoint adjudication may affect results if events are misclassified by public registries.
- Data quality in an RRCT is bound by the quality of the data in the register
- Lack of structured follow-up for safety events
- Potential for crossover between treatment arms
- Lack of endpoint adjudication may lead to misclassification
Cite This Study
Yndigegn et al. (2018) conducted a review in Cardiovascular disease. Registry-based randomised clinical trial (RRCT) design vs. Traditional randomized clinical trial was evaluated. Registry-based randomised clinical trials leverage existing quality registries to conduct large-scale, pragmatic trials, potentially reducing costs by up to 90% compared to traditional RCTs.
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