[Urogenital cancer studies in view of new legislation].
Harmonization of European GCP-V-related decrees crushed German urogenital cancer study activities and has led to complete discontinuation of investigator-initiated studies since August 2004. For renal cell carcinoma, the two major branches of the German cancer society (Deutsche Krebsgesellschaft e.V.), the Association for Urogenital Oncology (AUO) and the Association for (Internal) Medical Oncology (AIO), founded a Renal Cancer Task Force Group composed of the active members of the former "Intergroup Competence Network Renal Carcinoma" (IKN-N) in the spring of 2004. The resulting intergroup consortium represents an overall community of more than 100 German clinical departments that are highly experienced in oncological studies and ready to go for future trials. The basic ideas of the concept were transparency, multilateral consultations within the Task Force, and early involvement of national and international representatives of pharmaceutical companies and medical care insurance providers in the process of future study developments. Therefore, two pharmaceutical hearings took place at the University of Frankfurt.
Rohde
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Arbeitsgemeinschaft Urologische Onkologie, Urologische Klinik, Klinikum, Darmstadt. detlef.rohde@klinikum-darmstadt.de
D026683:Advisory Committees / Q000331:legislation & jurisprudence*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003299:Cooperative Behavior; D004345:Drug Industry / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational / Q000627:therapeutic use*; D005858:Germany; D006801:Humans; D007348:Insurance, Health / Q000331:legislation & jurisprudence; D007400:Interprofessional Relations; D007680:Kidney Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents; D015507:Drugs, Investigational