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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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%).</p> <p>Conclusion</p> <p>The results indicate that there is still insufficient attention paid to the implementation of interim analysis.</p

Spatial distribution and secondary production of Copepoda in a tropical reservoir: Barra Bonita, SP, Brazil

The present paper aims to describe the spatial distribution of zooplankton copepods, their biomass and instantaneous secondary production, in Barra Bonita, a large eutrophic, polymitic reservoir (22° 29' S and 48° 34' W) on the Tietê River, of the Paraná basin. Sampling was carried out during two seasons: dry winter and rainy summer. Species composition, age structure and numerical density of each copepod species population were analyzed at 25 sampling stations. Secondary production was calculated for Copepoda, the dominant group in zooplankton communities, taking Calanoida and Cyclopoida separately. Copepoda represented the largest portion of the total zooplankton biomass, the dominant species being Notodiaptomus iheringi among the Calanoida and Mesocyclops ogunnus and Thermocyclops decipiens among the Cyclopoida. The production of Copepoda was higher during the rainy summer (23.61 mgDW.m-3.d-1 in January 1995) than during the dry winter season (14 mgDW.m-3.d-1 in August 1995), following the general pattern of abundance for the whole zooplankton community. Among the copepods, Cyclopoida production was higher than that of Calanoida, a pattern commonly observed for tropical lakes and reservoirs. Barra Bonita copepods are very productive, but there was a great degree of spatial heterogeneity, related to the physical and chemical conditions, particularly the level of nutrients and also to phytoplankton biomass