The Randomized Registry Trial: Two Birds, One Stone
Abstract
Because healthcare in the United States has become more value-based, patients, providers, and other stakeholders urgently need more high-quality clinical evidence. 1 Such evidence can inform clinical decisions, guide healthcare policies, evaluate care quality, and, ultimately, provide and assess value. Randomized clinical trials (RCTs) represent a criterion standard for evidence because of their ability to remove systematic biases and enhance insights into causality. Their complexity, need for scale, difficulties in patient and provider accrual, and immense costs, however, hamper their performance and completion. To overcome some of the challenges facing RCTs, trialists have recently begun to seek other ways to attain evidence. One such strategy is to leverage the abundance of clinical registries as data platforms for clinical trials. The registry-based randomized trial, or randomized registry trial (RRT), aims to approach the statistical rigor of randomization, whereas expediting and enhancing patient enrollment, minimizing cost, and addressing the generalizability of findings (Table 1). 2–5 TABLE 1: Comparison of Study DesignsThe first published RRT was conducted in Sweden. 3 In less than 3 years, 7244 patients across 3 countries in more than 30 sites were randomized. The trial was estimated to have costed only $50 per patient. 2,3,5 The first RRT in the United States was the Study of Access Site for Enhancement of Percutaneous Coronary Intervention (SAFE-PCI) for Women Tri…
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- Authors
- Liu, J. B., D’Angelica, M. I., & Ko, C. Y.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- University of California, Los Angeles (US)
- Corresponding author
- Liu, Jason B.
- Ko, Clifford Y.
- Venue
- Annals of Surgery
- Published
- 2017-06
- Volume
- 265
- Issue
- 6
- Pages
- 1064-1065
- ISSN
- 0003-4932 (ISSN-L)
- OpenAlex
- W2581710837
- Cited by
- 15
- References
- 7
- Citations by year
- 2025: 2 · 2023: 2 · 2022: 3 · 2020: 3 · 2018: 4 · 2017: 1
- FWCI
- 1.52
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of Surgery (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- clinical registries, trial accrual, trial cost reduction, generalizability, patient safety monitoring, National Cardiovascular Data Registry, National Surgical Quality Improvement Program, percutaneous coronary intervention, women's health, surgical quality improvement, value-based care, evidence generation, trial design comparison
- MeSH terms
- Humans, Registries, Randomized Controlled Trials as Topic
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