OPTIMON

The OPTIMON project (OPTImisation of MONitoring), begun before the establishment of the RECaP network and, involving several RECaP members, has contributed to the formation of the network. This project, now over, is about risk level analysis of clinical research studies. The starting hypothesis of Optimon is that it is possible to define an a priori monitoring strategy adapted to the risk of each clinical study which provides similar results to those of the strategy with 100% data monitored on site for major quality criteria and is superior for criteria like cost and the time of completion of the study. The principal investigator is Geneviève Chêne of the CIC-EC 1401 (Bordeaux), the project is funded by the call for proposals PHRC 2005. It fits in an approach aiming to put in evidence the terms of use of risk grids adapted to clinical research and to model the retention conditions in research in medium term and long-term.

The first results were presented at EPICLIN 9/22^nd Days of FCCC statisticians. The presentation is available on the Optimon website.

For more information : https://ssl2.isped.u-bordeaux2.fr/OPTIMON/default.aspx