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Audio conference highlights

Successful global oncology trials require careful planning, starting with looking at the strategic elements that span people, process and technology. Challenges in clinical research in oncology today include multiple new agents for multiple new targets combined with an increase in the number of patients needed to demonstrate that a therapy provides a significant benefit for patients. There is also a need to minimize the time it takes to go from basic science discoveries into clinical studies. The risk posed by delays in study start-up and patient recruitment can be mitigated by proactively planning for the study.

Planning needs to reflect the traditional and nontraditional considerations of feasibility and study design and incorporate trends and best practices. Patient recruitment is a key strategic consideration, along with epidemiological and genetic factors. Facilities, expertise and other resources along with technology play a key role in global trial planning.

Area-specific regulatory requirements vary in terms of standards of care, and differences among healthcare systems influence trial planning, as do local and cultural considerations.

This presentation focuses on the central challenges in global oncology trials today and make recommendations about how they might be addressed to mitigate risks in terms of timelines and costs.

This audio conference covers:

• The importance of a range of strategic considerations in planning global oncology trials
• Recognizing traditional and emerging or nontraditional considerations
• Understanding how variances in the regulatory and service delivery environment influence oncology trials
• How to utilize a strategic approach to planning to best ensure successful oncology trials

About the speaker:

Ute Berger, MD is Senior Director of Therapeutic Expertise, Oncology and Hematology, Scientific & Medical Affairs for PRA International, a global CRO with 2,700 employees, covering 64 countries on six continents. She earned her Doctor of Medicine degree from the University of Heidelberg and has served in senior positions on the Faculty of Clinical Medicine Mannheim, University of Heidelberg for more than 18 years. She holds medical certifications in internal medicine, oncology and hematology, and is certified by the European Society of Medical Oncology (ESMO). Dr. Berger has also held numerous prestigious and high-visibility professional positions, including Medical Coordinator for the German CML Study Group; General Manager of the German Competence Network “Acute and Chronic Leukemias”; and Scientific Network Manager of the “European LeukemiaNet”. Dr. Berger has particular expertise and a strong interest in clinical research and has published extensively in prominent journals.

Dr. Berger has established relationships with key opinion leaders in the hematology/oncology field around the world. She has very recent and relevant experience overseeing, directing and implementing global oncology trials in a variety of indications.

Who should attend?

• Heads of Research and Development
• VPs of Clinical Development
• Directors of Clinical Operations
• Therapeutic Area Leaders
• Program and Clinical Study Managers
• Directors of Outsourcing and Procurement
• VPs Global Data Management

This conference is rated General interest