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. Information was obtained on a) general characteristics of the protocol b) disease localization and patient setting c) study design d) interim analyses e) DSMC. 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. A template data extraction form was developed and tested in a pilot phase. Evaluation was restricted to protocols of randomised studies with a time to event endpoint, such as overall survival (OS) or progression free survival (PFS). Source of investigation were the protocols of cancer clinical trials included in the Italian registry of clinical trials from 2000 to 2005. This study focused on the prevalence of different types of interim analyses and data monitoring in cancer clinical trials. 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. Reports of studies rarely include details on the strategies for both data monitoring and interim analysis. Although interim analysis approaches in clinical trials are widely known, information on current practice of planned monitoring is still scarce.
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