Industry & Cooperative Groups Relationships: the European Perspective Eric Pujade-Lauraine Hôpital Hôtel-Dieu Paris, France.

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Industry & Cooperative Groups Relationships: the European Perspective Eric Pujade-Lauraine Hôpital Hôtel-Dieu Paris, France

Industry-Cooperative group relationships sales Industry Group science Good trials with active, well tolerated drugs for patient interest

Industry-Cooperative group relationships sponsor Industry Early development (phase I, early efficacy phase II, pivotal phase III for approval)Group Late development (organ-specific phase II, combination trials) sponsor

Industry-Cooperative group relationships Industry Group Early and Late development sponsor speed:short time for license concurrence Expertise opinion leaders prescriber network science prestige

Industry-Cooperative group relationships Early and Late developmentIndustry sponsor Group Expertise opinion leaders

Industry-Cooperative group relationships Steering Committee CRO Industry Group Monitoring Database Statistician IDSMC

Industry-Cooperative group relationships What to share and How ? - one protocol - one data base (ownership, - one crf (e-crf) - monitoring, SOPs, SAEs flow - statistical analysis - IDSMB - publication policy What rules between industry and cooperative groups ? ENGOT minimal requirement for Academic trials

Industry-Cooperative group relationships Concentrate on translationnal research TR plan Industry Group labs

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