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Berikashvili L.B.

Federal Research Clinical Center of Intensive Care and Rehabilitology

Polyakov P.A.

Federal Research Clinical Center for Intensive Care and Rehabilitation

Yadgarov M.Ya.

Federal Research Clinical Center of Intensive Care and Rehabilitology

Likhvantsev V.V.

Federal Research Clinical Center of Intensive Care and Rehabilitology

Interim data analysis and premature termination in superiority trials: a comprehensive guide and recommendations for multiple testing of the primary study hypothesis

Authors:

Berikashvili L.B., Polyakov P.A., Yadgarov M.Ya., Likhvantsev V.V.

More about the authors

Journal: Russian Journal of Anesthesiology and Reanimatology. 2024;(3): 49‑57

DOI: 10.17116/anaesthesiology202403149

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Table of contents

To cite this article:

Berikashvili LB, Polyakov PA, Yadgarov MYa, Likhvantsev VV. Interim data analysis and premature termination in superiority trials: a comprehensive guide and recommendations for multiple testing of the primary study hypothesis. Russian Journal of Anesthesiology and Reanimatology. 2024;(3):49‑57. (In Russ.)
https://doi.org/10.17116/anaesthesiology202403149

Подписка 2025 (АиР)
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OBJECTIVE

To elucidate the core principles of group sequential design (GSD) and adaptive design variant, and to offer well-grounded recommendations for its implementation in clinical superiority trials.

MATERIAL AND METHODS

We reviewed the literature data in the Web of Science, PubMed and Cochrane Library databases. Furthermore, the capabilities of the gsDesign package in the R programming environment were examined to enhance the analysis.

RESULTS

We highlighted the advantages and limitations of GSD, ideal usage scenarios and clear practical guidelines. We also gave the insights on result interpretation and methodological guidelines.

CONCLUSION

Large randomized controlled trials are a cornerstone of contemporary medical research. Premature termination of the study not only conserves valuable scientific resources and time but also mitigates the risk of adverse effects on patient health. The guidelines and data interpretation principles can improve the approaches to work with this adaptive design of superiority trials when testing the main study hypothesis (primary endpoint).

Keywords:

premature termination of clinical trials
study design
sample size
data interpretation

Authors:

Berikashvili L.B.

Federal Research Clinical Center of Intensive Care and Rehabilitology

Polyakov P.A.

Federal Research Clinical Center for Intensive Care and Rehabilitation

Yadgarov M.Ya.

Federal Research Clinical Center of Intensive Care and Rehabilitology

Likhvantsev V.V.

Federal Research Clinical Center of Intensive Care and Rehabilitology

Received:

30.12.2023

Accepted:

24.01.2024

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