The pharmaceutical industry and oncology in Central and Eastern Europe

• Published in: Annals of oncology Vol. 10; no. suppl-6; pp. S15 - S17
• Main Authors: Ben-Am, M., Gemperli, B., Covelli, A., Burke, G.
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Oxford Elsevier Ltd 1999; Oxford University Press
• Subjects: Antineoplastic Agents - therapeutic use; Biological and medical sciences; Central and Eastern Europe; Clinical trial. Drug monitoring; clinical trials; Clinical Trials as Topic - legislation & jurisprudence; Clinical Trials as Topic - standards; Clinical Trials as Topic - trends; Drug Evaluation - legislation & jurisprudence; Drug Evaluation - standards; Drug Evaluation - trends; Drug Industry - legislation & jurisprudence; Drug Industry - standards; Drug Industry - trends; Europe, Eastern; European Union; GCP; General pharmacology; Humans; ICH; Medical Audit; Medical Oncology; Medical sciences; oncology; Patients; Pharmacology. Drug treatments; Research Personnel - standards; Eastern Europe; Central Europe; Europe; Europe, Eastern; Central and Eastern Europe; clinical trials; GCP; oncology; ICH; Antineoplastic agent; Human; Clinical trial; Cancerology; Pharmaceutical industry
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/10.suppl_6.S15

Major opportunities exist for patients, investigators and the pharmaceutical industry in oncology drug development in Central and Eastern Europe. Novel therapeutics may be offered for investigational use in selected centres capable of adherence to Good Clinical Practice (GCP). Requirements for participation in oncology clinical trials include the availability of experienced qualified investigators highly motivated to conform with the principles of GCP (International Harmonization (ICH) guidelines); availability of appropriate Institutional Review Board for Human Subjects (IRB), access to appropriate patient populations, access to individual patient data, acceptance of possible audit by sponsoring companies and the Food and Drug Administration (FDA), and a willingness to participate in the generation of new knowledge. Patients gain through access to novel therapeutics. We have had success in performing clinical trials to international standards in Central and Eastern Europe. This experience will be described.