Approaches to interim analysis of cancer randomised clinical trials with time to event endpoints: A survey from the Italian national monitoring centre for clinical trials

Irene Floriani, Nicole Rotmensz, Elena Albertazzi, Valter Torri, Marisa De Rosa, Carlo Tomino, Fillipo de Braud

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Abstract

Background: Although interim analysis approaches in clinical trials are widely known, information on current practice of planned monitoring is still scarce. Reports of studies rarely include details on the strategies for both data monitoring and interim analysis. The aim of this project is to investigate the forms of monitoring used in cancer clinical trials and in particular to gather information on the role of interim analyses in the data monitoring process of a clinical trial. This study focused on the prevalence of different types of interim analyses and data monitoring in cancer clinical trials. Methods: Source of investigation were the protocols of cancer clinical trials included in the Italian registry of clinical trials from 2000 to 2005. Evaluation was restricted to protocols of randomised studies with a time to event endpoint, such as overall survival (OS) or progression free survival (PFS). A template data extraction form was developed and tested in a pilot phase. Selection of relevant protocols and data extraction were performed independently by two evaluators, with differences in the data assessment resolved by consensus with a third reviewer, referring back to the original protocol. Information was obtained on a) general characteristics of the protocol b) disease localization and patient setting; c) study design d) interim analyses; e) DSMC. Results: The analysis of the collected protocols reveals that 70.7% of the protocols incorporate statistical interim analysis plans, but only 56% have also a DSMC and be considered adequately planned. The most concerning cases are related to lack of any form of monitoring (20.0% of the protocols), and the planning of interim analysis, without DSMC (14.7%). Conclusion: The results indicate that there is still insufficient attention paid to the implementation of interim analysis.

Original languageEnglish
Article number46
JournalTrials
Volume9
DOIs
Publication statusPublished - Jul 25 2008

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Randomized Controlled Trials
Clinical Trials
Neoplasms
Disease-Free Survival
Registries
Surveys and Questionnaires
Survival

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

@article{e4479ee7ce464449b1e801185387a499,
title = "Approaches to interim analysis of cancer randomised clinical trials with time to event endpoints: A survey from the Italian national monitoring centre for clinical trials",
abstract = "Background: Although interim analysis approaches in clinical trials are widely known, information on current practice of planned monitoring is still scarce. Reports of studies rarely include details on the strategies for both data monitoring and interim analysis. The aim of this project is to investigate the forms of monitoring used in cancer clinical trials and in particular to gather information on the role of interim analyses in the data monitoring process of a clinical trial. This study focused on the prevalence of different types of interim analyses and data monitoring in cancer clinical trials. Methods: Source of investigation were the protocols of cancer clinical trials included in the Italian registry of clinical trials from 2000 to 2005. Evaluation was restricted to protocols of randomised studies with a time to event endpoint, such as overall survival (OS) or progression free survival (PFS). A template data extraction form was developed and tested in a pilot phase. Selection of relevant protocols and data extraction were performed independently by two evaluators, with differences in the data assessment resolved by consensus with a third reviewer, referring back to the original protocol. Information was obtained on a) general characteristics of the protocol b) disease localization and patient setting; c) study design d) interim analyses; e) DSMC. Results: The analysis of the collected protocols reveals that 70.7{\%} of the protocols incorporate statistical interim analysis plans, but only 56{\%} have also a DSMC and be considered adequately planned. The most concerning cases are related to lack of any form of monitoring (20.0{\%} of the protocols), and the planning of interim analysis, without DSMC (14.7{\%}). Conclusion: The results indicate that there is still insufficient attention paid to the implementation of interim analysis.",
author = "Irene Floriani and Nicole Rotmensz and Elena Albertazzi and Valter Torri and {De Rosa}, Marisa and Carlo Tomino and {de Braud}, Fillipo",
year = "2008",
month = "7",
day = "25",
doi = "10.1186/1745-6215-9-46",
language = "English",
volume = "9",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

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T1 - Approaches to interim analysis of cancer randomised clinical trials with time to event endpoints

T2 - A survey from the Italian national monitoring centre for clinical trials

AU - Floriani, Irene

AU - Rotmensz, Nicole

AU - Albertazzi, Elena

AU - Torri, Valter

AU - De Rosa, Marisa

AU - Tomino, Carlo

AU - de Braud, Fillipo

PY - 2008/7/25

Y1 - 2008/7/25

N2 - Background: Although interim analysis approaches in clinical trials are widely known, information on current practice of planned monitoring is still scarce. Reports of studies rarely include details on the strategies for both data monitoring and interim analysis. The aim of this project is to investigate the forms of monitoring used in cancer clinical trials and in particular to gather information on the role of interim analyses in the data monitoring process of a clinical trial. This study focused on the prevalence of different types of interim analyses and data monitoring in cancer clinical trials. Methods: Source of investigation were the protocols of cancer clinical trials included in the Italian registry of clinical trials from 2000 to 2005. Evaluation was restricted to protocols of randomised studies with a time to event endpoint, such as overall survival (OS) or progression free survival (PFS). A template data extraction form was developed and tested in a pilot phase. Selection of relevant protocols and data extraction were performed independently by two evaluators, with differences in the data assessment resolved by consensus with a third reviewer, referring back to the original protocol. Information was obtained on a) general characteristics of the protocol b) disease localization and patient setting; c) study design d) interim analyses; e) DSMC. Results: The analysis of the collected protocols reveals that 70.7% of the protocols incorporate statistical interim analysis plans, but only 56% have also a DSMC and be considered adequately planned. The most concerning cases are related to lack of any form of monitoring (20.0% of the protocols), and the planning of interim analysis, without DSMC (14.7%). Conclusion: The results indicate that there is still insufficient attention paid to the implementation of interim analysis.

AB - Background: Although interim analysis approaches in clinical trials are widely known, information on current practice of planned monitoring is still scarce. Reports of studies rarely include details on the strategies for both data monitoring and interim analysis. The aim of this project is to investigate the forms of monitoring used in cancer clinical trials and in particular to gather information on the role of interim analyses in the data monitoring process of a clinical trial. This study focused on the prevalence of different types of interim analyses and data monitoring in cancer clinical trials. Methods: Source of investigation were the protocols of cancer clinical trials included in the Italian registry of clinical trials from 2000 to 2005. Evaluation was restricted to protocols of randomised studies with a time to event endpoint, such as overall survival (OS) or progression free survival (PFS). A template data extraction form was developed and tested in a pilot phase. Selection of relevant protocols and data extraction were performed independently by two evaluators, with differences in the data assessment resolved by consensus with a third reviewer, referring back to the original protocol. Information was obtained on a) general characteristics of the protocol b) disease localization and patient setting; c) study design d) interim analyses; e) DSMC. Results: The analysis of the collected protocols reveals that 70.7% of the protocols incorporate statistical interim analysis plans, but only 56% have also a DSMC and be considered adequately planned. The most concerning cases are related to lack of any form of monitoring (20.0% of the protocols), and the planning of interim analysis, without DSMC (14.7%). Conclusion: The results indicate that there is still insufficient attention paid to the implementation of interim analysis.

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