Paper II: thematic framework analysis of registry-based randomized controlled trials provided insights for designing trial ready registries

Research and innovation are critical for advancing the multidisciplinary management of pancreatic cancer. Registry-based studies (RBSs) are a complement to randomized clinical trials (RCTs). Compared with RCTs, RBSs offer cost-effectiveness, larger sample sizes, and representation of real-world clinical practice. National population-based registries (NPBRs) aim to cover the entire national population, and studies based on NPBRs are, compared to non-NPBRs, less prone to selection bias. The last decade has witnessed a dramatic increase in NPBRs in pancreatic cancer surgery, which has undoubtedly added invaluable knowledge to the body of evidence on pancreatic cancer management. However, several methodological shortcomings may compromise the quality of registry-based studies. These include a lack of control over data collection and a lack of reporting on the quality of the source registry or database in terms of validation of coverage and data completeness and accuracy. Furthermore, there is a significant risk of double publication from the most commonly used registries as well as the inclusion of historical data that is not relevant or representative of research questions addressing current practices.

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Use cases of registry‐based randomized controlled trials—A review of the registries' contributions and constraints

Kubesch,

Gaitonde,

Petriti

et al. 2024

Clinical Translational Sci

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Registry‐based randomized controlled trials (RRCTs) can combine the advantages of registries with those of randomization. This review aimed to expand the current knowledge on RRCT utilization and implementation by providing a comprehensive overview of RRCT use cases. A targeted literature search was conducted through July 2023 to identify articles on RRCTs. Information regarding the RRCT characteristics, their utilization, and the registries' contributions and the constraints faced was extracted. Descriptive statistics were used. We identified 102 RRCTs in 110 publications. RRCTs were mostly performed for the assessment of medical devices or surgical/clinical procedures (n = 45), followed by drugs (n = 30). More than half of the RRCTs were conducted in the Nordic countries (n = 58) and the most used registry types were health service registries/administrative health data (n = 63), followed by disease registries (n = 46). Approximately half of the RRCTs (n = 53) utilized additional data sources aside from registry data. The contribution of a registry to the RRCT was mostly for data collection and study follow‐up (n = 90–92), followed by patient recruitment (n = 56–61), and randomization (n = 28–38), with varying levels of transparency in reporting. We collated author‐reported constraints related to the used registries into four overarching themes, that is, data availability and completeness, data quality, representativeness, and registry infrastructure and accessibility. This review shows that RRCTs are already used in different domains and geographic regions. Guidelines on structured and transparent reporting of RRCT methods and the optimal use are, however, needed to inform decision‐making by health authorities and to reach their full potential.

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Paper II: thematic framework analysis of registry-based randomized controlled trials provided insights for designing trial ready registries

Cited by 6 publications

References 57 publications

A methodological review identified several options for utilizing registries for randomized controlled trials

A methodological review identified several options for utilizing registries for randomized controlled trials

The role of national population-based registries in pancreatic cancer surgery research

Use cases of registry‐based randomized controlled trials—A review of the registries' contributions and constraints

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