The single greatest challenge to drug development today is successful patient accrual. The sheer volume of actively recruiting trials advertised by the NIH -- nearly 16,000 in 2006 -- illustrates the extensive competition for patients to participate in clinical trials in the United States. In an effort to access more patient populations to address these issues, it has become necessary to include a global mix of countries.
The key to including sites outside the United States is understanding exactly where the selected patient populations are located. Detailed feasibility is a critical step to planning and conducting successful global clinical trials. Understanding the medical standards of care, local healthcare systems, national health insurance and reimbursement, drug importation and tax implications, local regulatory requirements and treatment paradigms are all essential to determining where globally to place a specific clinical trial.
This presentation focuses on how to perform global feasibility to aid in the planning and conduct of clinical trials to economize your development times and clinical trial costs and explores the benefits of including regions such as Eastern Europe, Latin America, Asia and India.
This audio conference covers:
- Decision-making steps on which types of trials should be considered for the inclusion of global sites and why
- The benefits of including Latin America, Asia, India and Europe in clinical trials
- How to develop global feasibility, what types of questions to ask to understand which countries to include in a planned study
- Self-reported and questionnaire-based feasibility vs registry/data-based feasibility
- Beyond accrual, timelines and costs; why you should take clinical trials to emerging regions
About the speaker:
Kent Thoelke is Senior Vice President of Therapeutic Expertise, Scientific & Medical Affairs for PRA International, a global CRO with 2,700 employees, covering 64 countries on six continents. He has over 16 years of experience in the global drug development and device industry, having held positions in multinational R&D companies as well as small and emerging biotechnology companies.
Mr. Thoelke has particular expertise in the execution of all aspects of global hematology/oncology studies and previously led the oncology drug development efforts of a large CRO for six years. He has a comprehensive understanding of all stages of product development including regulatory, manufacturing, CMC, preclinical and clinical. Having visited hospitals and clinical sites in over 35 countries, Mr. Thoelke is also very familiar with the global clinical trial environment, and has established relationships with key opinion leaders in the field around the world. He has conducted clinical trials in the United States, Latin America, Eastern Europe, Asia and India and supported sponsor companies with regulatory bodies in the United States, Europe, China and India. Mr Thoelke has a strong interest in the utilization of emerging world countries for global clinical trials.
Who should attend?
- Heads of Research and Development
- VPs of Clinical Development
- Directors of Clinical Operations
- Therapeutic Area Leaders
- Program and Clinical Study/Project Managers
- Directors of Outsourcing and Procurement
This audio conference is classified as General Interest.