Register by April 4, 2008 and SAVE! 

Wednesday, May 7, 2008

11:30am – 1:30pm Registration

DRAFTING A GLOBAL ENROLLMENT STRATEGY

1:30 Chairperson’s Remarks

1:40 Restoring Public Trust in Clinical Research through Outreach and Education Kenneth A. Getz, M.S., Senior Research Fellow, Center for the Study of Drug Development, Tufts University This presentation will: 1) Review the current state of public distrust in the clinical research enterprise 2) Assess the impact of public distrust on patient recruitment and retention effectiveness 3) Examine the root causes of the erosion of trust 4) Discuss new strategies to restore public trust 5) Evaluate how well these strategies are working to date.

2:10 The Development of a Global Clinical Program Enrollment Strategy
Melissa Marshall, M.S., Assistant Director, Global Enrollment Planning and Performance, Wyeth Research
Review the critical success factors in optimizing enrollment for global clinical trials, including country feasibility and selection, data-driven enrollment forecasting, and a new approach to managing patient recruitment.

2:40 Regulatory Requirements for the Conduct of Studies in Asia and Latin America
Mark Dodge, B.S., Senior Director GRA, Intercontinental Regions, Wyeth

3:10 Networking Refreshment Break and Exhibit Viewing

3:40 Statistical Issues to Consider When Planning for Global Enrollment
Lawrence Schwartz, M.S., Deputy Director Principal Statistician, Bayer HealthCare

4:10 Ethical Issues in Recruiting Patients
James Saunders, M.B.A., Vice President, New England IRB
U.S. based clinical trials are experiencing increasing difficulty in recruiting and retaining subjects.  Designing techniques and materials used to identify and recruit candidates for participation in clinical trials can be challenging because they must meet a number of regulatory requirements, which provide the necessary safeguards for study candidates, as interpreted by the research investigator’s institutional review board. This talk will review these regulations and examine some real world examples of recruitment strategies, from the perspective of an experienced national independent institutional review board. The talk will focus on techniques that both meet these regulatory requirements and are successful in recruiting subjects.  The talk will also include a review and analysis of some techniques that did not.

4:40 Patient Recruitment in India - Issues Beyond the Investigator / Site
Vijai Kumar, M.D., President & Chief Medical Officer, Excel Life Sciences, Inc.
Patient recruitment and retention is crucial to the success of a clinical development program. In countries such as India, where the clinical trial enterprise is in the evolutionary stage, it is important to pay attention to a host of issues, these are; 1) whether the trial is global or restricted to Indian sites, 2) who pays for Standard of Care, 3) PI and site selection, and 4) choice of service partner (this is perhaps the most important determinant). It is crucial to select one with knowledge - domain, strategic and tactical, competence, experience, and ability to provide support service in the US. This depends on the ability to appreciate the client needs in the US and have adequate hands on Indian experience.

5:10 Panel Discussion with Speakers