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Registry or randomization - must it be evidence or could it be coincidence?
Olga Radulova1, Florian Oehme1,2,3,4,5, Sandra Korn1,2,3,4,5
1Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Innovative Surgical Sciences
|August 8, 2025
Summary
Clinical registries and randomized controlled trials (RCTs) have evolved, with new register-based RCTs merging their strengths. This review explores their history and future for high-quality clinical research.
Area of Science:
- Clinical research methodology
- Evidence-based medicine
Background:
- Clinical registries and randomized controlled trials (RCTs) are established study designs.
- Experience has elucidated the advantages and disadvantages of both approaches.
- Recent focus is on integrating RCTs and clinical registries.
Purpose of the Study:
- To review the historical development of clinical trials.
- To assess the current status of clinical trial methodologies.
- To explore future directions for high-quality clinical trials.
Main Methods:
- Literature review of clinical trial evolution.
- Analysis of past experiences with different study designs.
- Discussion of emerging trial concepts like register-based RCTs.
Main Results:
- RCTs and clinical registries offer distinct benefits and limitations.
- Register-based RCTs aim to combine the strengths of both designs.
- Continuous improvement in trial models is essential.
Conclusions:
- The field of clinical trials is advancing towards hybrid models.
- Understanding the evolution of study designs informs future research.
- Optimizing clinical trial methodologies enhances evidence quality.
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