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Industry & Cooperative Groups Relationships: the European Perspective Eric Pujade-Lauraine Hôpital Hôtel-Dieu Paris, France. Industry-Cooperative group relationships. Good trials with active, well tolerated drugs for patient interest. sales. science. Group. Industry.
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Industry & Cooperative Groups Relationships: the European PerspectiveEric Pujade-LauraineHôpitalHôtel-DieuParis, France
Industry-Cooperative group relationships Good trials with active, well tolerated drugs for patient interest sales science Group Industry
Industry-Cooperative group relationships Group Industry sponsor sponsor Late development(organ-specific phase II, combination trials) Early development (phase I, early efficacy phase II, pivotal phase III for approval)
Industry-Cooperative group relationships Early and Late development Group Industry sponsor Expertiseopinion leadersprescriber network • science • speed:short time for license • prestige • concurrence
Industry-Cooperative group relationships Early and Late development Industry Group sponsor Expertiseopinion leaders
Industry-Cooperative group relationships Steering Committee IDSMC Industry Group CRO MonitoringDatabaseStatistician
Industry-Cooperative group relationships What rules between industry and cooperative groups ? ENGOT minimal requirement for Academic trials • What to share and How ?- one protocol - one data base (ownership, - one crf (e-crf)- monitoring , SOPs, SAEs flow- statistical analysis- IDSMB- publication policy
Industry-Cooperative group relationships Concentrate on translationnal research Industry Group TR plan labs