"There are clear differences in the design and expertise needed for strategic research compared with registration research," said Dr Hugo Stephenson, president of >Quintiles Strategic Research Services, and author of the new book, titled "Strategic Research: A Practical Handbook for Phase IIIB and Phase IV Clinical Studies."
However, many researchers don't treat their approach to Phase IIIB and IV research any differently to other pre-approval studies. This can cause difficulties in coming up with a flexible and creative trial design, he told www.Outsourcing-Pharma.com.
Once a manufacturer applies for marketing approval on a drug, all subsequent research that is not conducted in-line with the product approval is termed Phase IIIB and all subsequent research that is conducted in-line with the product approval is called Phase IV.
Phase IIIB-IV clinical research in the US is now booming, growing 20 per cent annually, compared with only 7 per cent for Phase II-III research, driven by a surge in public drug safety concerns and increased drug market competitiveness.
Roughly 50 per cent of these studies are outsourced to contract research organisations (CROs) and academic research organisations (AROs) and the remainder are conducted by drug companies in-house.
"Given the current regulatory environment, I thought the time was right for a handbook to help clinical researchers and marketing 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," said Stephenson.
"Phase IIIB and IV studies have different dynamics to Phase I-III studies, and can often present new challenges," said Stephenson.
For example, patient recruitment can prove particularly problematic, because if the drug is commercially available (and reimbursed by the government), patients are less likely to bother participating in a clinical trial process, as the incentive of free access to a non-available drug is no longer there.
In addition, clinicians are also less likely to make the time to become involved.
"The book looks at different ways of overcoming such barriers and suggests new incentives for patient and clinician involvement," said Stephenson.
The book also provides a guide to the pros and cons of the various study designs possible in Phase IIIB and IV research, and clarifies definitions for those new to this area.
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, are also explained.
In addition, the book explores various approaches drug companies can take to simplify this research and in doing so, reduce costs, including outsourcing options and more efficient ways of data collection.
"Drug companies do Phase IIIB and IV research for various reasons, such as looking for a new marketing edge or examining return on investment, but they are always looking for a way to make these studies more cost effective," Stephenson said.