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The pharmaceutical industry and oncology in central and eastern Europe
M Ben-Am1, B Gemperli, A Covelli
1Novartis Pharma AG Basel, Switzerland. monique.ben-am@pharma.novartis.com
Abstract:
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.
Insights
Central and Eastern Europe offers significant opportunities for oncology drug development, providing patients access to novel therapeutics through clinical trials adhering to Good Clinical Practice (GCP) standards.
Area of Science:
- Oncology
- Clinical Trials
- Pharmaceutical Development
Background:
- Central and Eastern Europe presents a developing landscape for oncology drug development.
- Opportunities exist for patients, investigators, and the pharmaceutical industry.
Purpose of the Study:
- To describe the opportunities and requirements for conducting oncology clinical trials in Central and Eastern Europe.
- To highlight the success of conducting trials to international standards in the region.
Main Methods:
- The study focuses on the successful implementation of clinical trials in Central and Eastern Europe.
- It outlines the essential requirements for participation, including adherence to Good Clinical Practice (GCP) and International Harmonization (ICH) guidelines.
Main Results:
- Successful execution of clinical trials meeting international standards in Central and Eastern Europe has been achieved.
- Key requirements include qualified investigators, Institutional Review Board (IRB) approval, patient access, data integrity, and regulatory compliance.
Conclusions:
- Central and Eastern Europe is a viable region for oncology clinical trials.
- Adherence to GCP and established trial protocols enables the introduction of novel therapeutics to patients and contributes to advancing cancer research.