Determining Feasibility in Global Clinical Trials

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.

Determining Feasibility in Global Clinical Trials was presented by Kent Thoelke, Sr. Vice President, with PRA International and aired on 2007-08-02. This conference is available for download at www.fxconferences.com

Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines

One of the greatest risks to successful drug development today is delayed clinical development timelines. Detailed planning and appropriate site and country selection is the most critical factor in meeting target patient accrual goals within the planned timeline. Historically, site and country selections have been made primarily utilizing survey-based prospective feasibility. Unfortunately, survey-based feasibility alone is no longer sufficient to provide the detail necessary to select countries and sites to maximize patient accrual and minimize development timelines. An evidence-based methodology approach coupled with survey-based feasibility provides the most accurate forecast for patient accrual and the selection of sites and countries with the highest likelihood of being productive.

In this audio conference we will discuss the key items of an evidence-based approach to feasibility and ultimately, site and country selection.

Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines is being presented by Kent Thoelke, Sr. Vice President of Therapeutic Expertise, Scientific & Medical Affairs, with PRA International and airs on Wednesday, March 25, 2009. For more details or to register, please visit our site www.fxconferences.com

Determining Feasibility in Global Clinical Trials

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.

Determining Feasibility in Global Clinical Trials aired on 2007-08-02 and was presented by Kent Thoelke, Sr. Vice President, with PRA International. For more details please visit our site www.fxconferences.com