Projects: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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1 Erstellung einer Stellungnahme für den G-BA zur Nutzenbewertung eines VEGF-Rezeptor Hemmers Other Preparation of a response document for the G-BA benefit assessment Erstellung eines Dossiers für eine Nutzenbewertung gemäß Paragraph 35a SGB V für einen VEGF-Rezeptor Hemmer Other Preparation of a value dossier according to para 35a SGB V A pharmacodynamic equivalence study on intramuscular versus subcutaneous application of an LH-RH analogon in patients with advanced prostate cancer A pharmacodynamic equivalence study on intramuscular versus subcutaneous application of an LH-RH analogon in patients with advanced prostate cancer Ethics commitee procedure and authorities Sample size: 100 Page 1 of 7
2 Überprüfung einer statistischen Auswertung auf Plausibilität und Richtigkeit durch einen Statistiker Other Sample size: 600 Publikationsservice für Anwendungsbeobachtung Prostatakarzinom Other Publication A pharmacodynamic equivalence study on intramuscular versus subcutaneous application of an LH-RH analogon in patients with advanced prostate cancer Review of documents Ethics commitee procedure and authorities Reimbursement according to ICH Topic E 3 Sample size: 100 Phase III Study of a multi-targeted receptor tyrosine kinase inhibitor in Subjects with Advanced Renal Cell Cancer prior to Radical Kidney Surgery, study protocol Review of documents Ethics commitee procedure and authorities I Page 2 of 7
3 A multicenter, randomized, double-blind, phase 3 study in patients with advanced/metastatic non-small cell lung cancer I Sample size: 90 A phase II open-label, multi-centre, randomised, prospective, parallel-group study comparing two cytostatic drugs as second line treatment in patients with relapsed extensive disease small cell lung cancer Sample size: 225 Anwendungsbeobachtung mit einem Hormon bei Patienten mit Prostata-Karzinom Non-interventional study Recruitment of sites Notification to authorities Reimbursement Statistical report Sample size: 500 Page 3 of 7
4 A randomized, double-blind, placebo-controlled trial of the prevention and treatment of chemotherapy-induced peripheral neuropathy symptoms with a new substance in subjects with advanced colorectal cancer Pharmacovigilance I Sample size: 10 Telefoninterviews mit Prüfzentren zur Einholung von Feasibility-Checks für eine Studie bei Mamma-Karzinom Other Telephone interviews within the scope of feasibility checks Zytostatikum in der second-line Therapie bei Patienten mit kleinzelligem Bronchialkarzinom Additional statistical analysis Sample size: 170 A trial of a monoclonal anti-idiotype antibody in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer according to ICH Topic E 3 Phase: I/II Sample size: 36 Diagnostik des Prostatakarzinoms bei Patienten mit benigner Prostatahyperplasie - offene, prospektive Phase-IV-Studie Conception of study design Statistical planning Phase: IV Sample size: 132 Page 4 of 7
5 A randomised, single-centre, double-blind, placebo-controlled, parallel-group pilot study evaluating the efficacy of a natural ointment in breast cancer patients with secondary lymphoedema Statistical planning I Sample size: 30 Anwendungsbeobachtung zur additiven Therapie mit einem Phytopharmakon bei Patientinnen mit Mamma-Karzinom und adjuvanter Chemotherapie Non-interventional study Reimbursement Sample size: 271 Phase I trial of a monoclonal anti-idiotype antibody in patients with epithelial ovarian, fallopian tube, or peritoneal cancer according to ICH Topic E 3 Phase: I Sample size: 42 Page 5 of 7
6 Anti-idiotype vaccine for patients with advanced ovarian carcinomas with an murine monoclonal anti-idiotype antibody - Determination of immunological therapy effect Statistical report Phase: Ib/II Sample size: 119 Anwendungsbeobachtung mit einem pflanzlichen Arzneimittel in der Nachsorgebehandlung von Patienten mit malignen Tumoren Non-interventional study Sample size: 906 Zytostatikum in der second-line Therapie bei Patienten mit kleinzelligem Bronchialkarzinom Sample size: 170 Page 6 of 7
7 Klinische Studie mit einem pflanzlichen Arzneimittel in der Nachsorgebehandlung von Patienten mit malignen Tumoren Phase: IV Sample size: 200 Page 7 of 7
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