Clinical Trials in the Developing World: Planning, Conducting, Monitoring, Defending

With every month, a larger number of industry, academic and government-funded clinical trials are initiated outside the U.S., often in developing economies of South America, Southeast Asia, India, Africa or the states of the former Soviet Union. 

While expanding clinical trials to developing countries can help companies to open new markets and expand research, it can also pose problems for those companies without sufficient knowledge of the strategies needed to plan and sustain these studies. 

In this 90-minute audio conference, Mark Barnes will address the common issues and risks that arise in clinical trials in the developing world, and most importantly, how to plan, manage and monitor for risks of all types.

How You Will Benefit From Attending This Audio Conference:

• Learn how to identify collaborators and investigators and how to determine who and what entities to avoid
• Discover how to plan for the end of the study, from the outset of the study
• Understand what “fair national access” to drugs means for your clinical trial
• Examine strategies for monitoring trials in a developing country context
• Find out what criteria to use in selecting a CRO
• Learn how to use community advisory boards to help your clinical trials
• Determine how to deal with informed consent in developing countries, including how to anticipate challenges and how to ensure you have the necessary documentation

Attendees Who Will Benefit From This Audio Conference Include:

• ANYONE involved in planning and monitoring clinical trials in the developing world
• Clinical project specialists
• CRAs and investigators
• Regulatory/clinical affairs
• Consultants/service providers
• Executive management
• General/corporate counsel
• Risk management specialists

Mark Barnes
Mark Barnes serves at Harvard as Senior Advisor to the Provost, University Chief Research Compliance Officer, and the University's Director for Sponsored Research. Mark recently was a Managing Director at Huron Consulting, focusing on the international needs of academic medical centers and research universities. He previously served as Executive Vice President, Chief Administrative Officer and Director of Research Operations at St. Jude Children's Research Hospital. He has practiced and taught law and has administered government programs in the health care field for the past 25 years. He is recognized as one of the leading authorities on clinical trials, research compliance, federal grants compliance, medical privacy, and healthcare infrastructure development. Mark earned his J.D. from the Yale Law School, and an LL.M. from the Columbia School of Law. He holds faculty appointments at Yale Medical School and Harvard Law School.