RESEARCH TRIANGLE PARK, N.C., Dec. 13 /PRNewswire/ -- Patients, physicians, payers and politicians are calling for more information on the risks and benefits of prescription drugs. At the same time, some organizations are questioning the value of direct-to-consumer advertising.
These two related forces have resulted in a surge of interest in Phase IIIB and IV research. A Tufts University report says that more than 73% of New Drug Applications (NDAs) are associated with at least one Phase IV research commitment, while the industry trade publication CenterWatch estimates that Phase IIIB-IV research is growing at an annual rate of 20%, compared with Phase II-III growth of 7%.
To help pharmaceutical and biotechnology customers maximize the return on their investment in Phase IIIB and IV research and deal effectively with post- marketing safety issues, Hugo Stephenson, M.D., President of Quintiles Strategic Research Services, has written "Strategic Research: A Practical Handbook for Phase IIIB and Phase IV Clinical Studies."
"There are clear differences in the design and expertise needed for strategic research compared with registration research," Dr. Stephenson said. "Given the current regulatory environment, I thought the time was right for a handbook to help clinical researchers and brand teams apply strategic research to address questions that are not answered at the time of registration, from 'real world' safety and effectiveness to competitive positioning."
The book explores ways to motivate investigators and drive high- performance site activity, taking advantage of study dynamics unique to the peri- and post-approval period. In addition, the book provides a handy reference guide to the myriad of study designs possible in Phase IIIB and IV research, with insights into the pros and cons of each approach. It also clarifies definitions for those new to this area. For marketers, there are valuable tips on maximizing the value of the study in terms of publishable results and return on investment. Finally, Dr. Stephenson explains the nuances of conducting post-approval clinical research in different countries in compliance with local regulations, including the Anti-kickback Statute and the False Claims Act in the United States.
The book concludes with an examination of the Vioxx withdrawal and its implications for the pharmaceutical industry, including the need for more prospective post-marketing research.
"Strategic Research: A Practical Handbook for Phase IIIB and Phase IV Clinical Studies" is available on amazon.com.
About the Author
Dr. Stephenson is president of Quintiles Strategic Research Services. He founded Health Research Solutions (HRS), an Australian strategic research service provider acquired by Quintiles in 2002. He is a medical doctor with a particular interest in strategic epidemiology and drug safety risk management, and he works closely with senior industry strategists to promote the use of strategic research activities to support advances in pharmaceutical research.
Prior to founding HRS, he served as a consultant to a number of leading international pharmaceutical companies. He is an Honorary Life Governor at Royal Children's Hospital in Melbourne, has authored and co-authored many articles, and he holds degrees in medicine and surgery from the University of Melbourne.
About Quintiles
Quintiles is the global leader in pharmaceutical services. We improve healthcare worldwide by providing quality professional expertise, market intelligence and innovative partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Quintiles has 16,000 specialized employees and offices in 50 countries. For more information visit the company's Web site at www.quintiles.com.
QuintilesCONTACT: Dick Jones, Media Relations, +1-919-998-2091, ormedia.info@quintiles.com, or Greg Connors, Investor Relations,+1-919-998-2000, or invest@quintiles.com, both of Quintiles
Web site: http://www.quintiles.com/
