[Advantages and problems of multicenter therapy studies exemplified by a study of the treatment of metastasizing renal cell carcinoma with recombinant interferon-alpha-2c].
The advantages of multicenter trials are numerous: quicker recruitment of the necessary number of patients, clearer results which are more convincing and whose acceptance is higher, as the patient sample of multicenter trials is supposed to be representative. However, multicenter trials require strong efforts for quality assurance concerning admission, treatment and follow-up, thus a highly developed coordinating center is needed. Data on recruitment and protocol compliance, i.e. deviations from the study protocol, are presented for the study of the treatment of metastatic renal cell carcinoma and discussed with respect to their impact on the results of the study. 102 patients were randomized either for IFN alpha-2C or IFN alpha-2C plus medroxyprogesteroneacetate. 16% of the patients violated inclusion criteria and essential data were missing in 16% of the patients. Overall treatment results (remission rate of 5.6%, median survival time of 7 months) and the data on adverse events have been biased by lack of protocol compliance. However, the results concerning the lack of differences between treatments remain valid.
D002292:Carcinoma, Renal Cell / Q000628:therapy*; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination; D006801:Humans; D007370:Interferon Type I / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000628:therapy*; D008525:Medroxyprogesterone / Q000031:analogs & derivatives / Q000627:therapeutic use; D017258:Medroxyprogesterone Acetate; D009362:Neoplasm Metastasis; D011897:Random Allocation; D011994:Recombinant Proteins / Q000627:therapeutic use*
D007370:Interferon Type I; D011994:Recombinant Proteins; D017258:Medroxyprogesterone Acetate; D008525:Medroxyprogesterone
Vorteile und Probleme multizentrischer Therapiestudien am Beispiel einer Studie zur Behandlung des metastasierenden Nierenzellkarzinoms mit rekombinantem Interferon-Alpha-2C.