Global Trials Get Personal

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-07-01-2010, Volume 0, Issue 0

Personalized medicine enters the arena.

Personalized medicine has become one of the buzz phrases in global health care over the past couple of years, and it is being used increasingly in the drug development field. But what exactly does it mean? And does the term have any great relevance for clinical trial organizers?

Conference organizers are now attempting to provide some answers to these and other controversial questions. They are honing in on the potentially lucrative area of personalized medicine, and October promises to be a bumper month for meetings. In the United States, the Third Annual Personalized Health Care National Conference will take place in Columbus, Ohio, October 14-15. During the same week, the United Kingdom will host "Personalized Medicine: The Collective Approach to Individualized Healthcare," which will be held October 11-12 at London's Crowne Plaza City Hotel.

In addition to the latest science and R&D trends, the program for the London event will look at business strategies and legal issues for developing personalized therapeutics and introducing them to the marketplace. Speakers will discuss how to identify and develop validation biomarkers as tools for personalized medicine, and how to use stem-cell technology to implement a more personalized therapeutic regime. They will also focus on successful partnerships, regulatory challenges, deep resequencing as a tool for drug repositioning, and integrating biomarker discovery and execution.

Information integration

Initially, experts thought personalized medicine referred merely to targeted therapy, but many people now view this definition as too narrow. For instance, on the Lab Soft News Web site in February 2010, Brian R. Jackson, MD, Medical Director of Informatics at ARUP Laboratories, noted that personalized medicine should be thought of in terms of the information integration necessary for patient care.

"The two ends of the spectrum in my mind are population medicine and personalized medicine. Population medicine is essentially evidence-based medicine. It gets criticized for being cookbook, but the fact is that there is important information value in studying large groups of patients at a time—think where we'd be if randomized clinical trials didn't exist," he wrote.

At the other end of the spectrum is personalized medicine (i.e., acquiring and integrating more and more patient-specific information). Jackson believes real progress will be made when we figure out how to properly balance and take advantage of both population-based information and personalized information and apply that to individual patients.

Collaborative effort

For those keen to learn more, there are numerous Web sites devoted to the subject, including the well-resourced Personalized Medicine Coalition (PMC). This coalition aims to educate federal and state policymakers and private sector health care leaders, helping them understand the science, the issues, and what is needed for the evolution of personalized medicine.

According to its mission statement, the PMC collaborates with member organizations and outside experts to identify, analyze, and address the ethical, legal, and social implications of personalized medicine. It provides a forum for debating and reaching consensus on public policy issues, and educates policymakers and health care leaders about the importance of personalized medicine and its evolution.

Additionally, it serves as an umbrella organization for stakeholders who are conducting personalized medicine education in both the public and private sector, and provides networking opportunities for the many and varied stakeholders.

Once the conferences have taken place this October, the future outlook and prospects should become much more clear.—Philip Ward