The pharmaceutical industry and oncology in central and eastern Europe.
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.
Ben-Am
M
M
Novartis Pharma AG Basel, Switzerland. monique.ben-am@pharma.novartis.com
Gemperli
B
B
Covelli
A
A
Burke
G
G
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends; D004341:Drug Evaluation / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends; D005061:Europe, Eastern; D005062:European Union; D006801:Humans; D008485:Medical Audit; D008495:Medical Oncology; D010361:Patients; D012108:Research Personnel / Q000592:standards
D000970:Antineoplastic Agents