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.
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Details
1 Istituto di Ricerche Farmacologiche "Mario Negri", Department of Oncology, Milan, Italy (GRID:grid.4527.4) (ISNI:0000000106678902)
2 European Institute of Oncology, Division of Epidemiology and Biostatistics, Milan, Italy (GRID:grid.15667.33) (ISNI:0000000417570843)
3 Interuniversity Consortium, Bologna, Italy (GRID:grid.35247.37)
4 AIFA (Italian Drug Agency), Osservatorio Italiano Sperimentazioni Cliniche, Roma, Italy (GRID:grid.487250.c) (ISNI:0000 0001 0686 9987)
5 European Institute of Oncology, Unit of Clinical Pharmacology and New Drugs, Milan, Italy (GRID:grid.15667.33) (ISNI:0000000417570843)