Almost All New Drug Approvals Receive FDA Requests for Post-Marketing Studies
Posted on: Wednesday, 2 August 2006, 09:00 CDT
EAST BRUNSWICK, N.J., Aug. 2 /PRNewswire/ -- Phase IV studies are continuing to increase, and based on a Tufts study, 73% of recent new drug approvals received FDA requests for post-marketing studies. The median cost of conducting these studies is also skyrocketing. Another costly and critical factor in conducting clinical trials, Phase I-IV, is the patient and investigator recruitment area which is one the most time consuming and difficult tasks within drug development.
These issues will be addressed at Strategic Research Institute's Phase IV Clinical Trials with special sessions on patient/ investigator recruitment and retention on October 23-24, 2006 at the Hilton East Brunswick in East Brunswick, NJ. Craig Eagle, M.D., Senior Director, Head of World Wide Medical Oncology at Pfizer, will deliver the keynote presentation titled "Phase IV and Beyond: What is Being Explored?"
Some additional featured topics include: * The Importance of PMCs * Selecting and Qualifying Investigators * Developing Strategies for the Measurement of Patient Reported Outcomes (PROs) * Key Drivers & Growth Opportunities in Phase IV Trials * Patient Recruitment and Retention: Challenges and Opportunities * Effective Use of Technology for Data Collection and Analysis * Optimizing Your Post-Marketing Research-How to Align the Interests of Multiple Stakeholders
This summit brings together a plethora of top level executives that will discuss the current issues and trends of today. The complete list of participating companies and institutions includes: Abbott; AstraZeneca; Bristol-Myers Squibb; Edwards Lifesciences; Galt Associates; GlaxoSmithKline; King Pharmaceuticals; Merck; Ortho-McNeil; Pfizer; Scirex; Takeda Pharmaceuticals North America; The Center for Info & Study on Clinical Research Participation.
To receive the full agenda in PDF, register, or information on becoming a media partner or sponsor/ exhibitor, please contact Amy Yuehof Strategic Research Institute at ayueh@srinstitute.com or 212-967-0095, x258. The conference website is http://www.srinstitute.com/pct.
Strategic Research Institute http://www.srinstitute.com/
Strategic Research Institute
CONTACT: Amy Yuehof, Strategic Research Institute, +1-212-967-0095,x258, ayueh@srinstitute.com
Web site: http://www.srinstitute.com/http://www.srinstitute.com/pct
Source: PRNewswire
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