The Lewin Group Report Urges Alignment of Comparative Effectiveness Research and Personalized Medicine
October 28, 2009
Actions specified to emphasize new evidence for subgroups and individuals, not just population averages
FALLS CHURCH, VA – October 28, 2009 – The Lewin Group Center for Comparative Effectiveness Research released a report prepared for the Personalized Medicine Coalition describing how comparative effectiveness research (CER) can be designed, conducted, and reported to better align with personalized medicine, achieving a synergy toward improved patient outcomes.
(Click here to download the report)
While CER has been oriented largely toward evaluating treatment effects across study populations, personalized medicine focuses on using individuals’ genomic information and other personal traits to inform decisions about their health care. It is essential that these emerging initiatives evolve to complement, not contradict, each other.
“CER must account for the different and sometimes entirely unanticipated ways in which therapies and other health care interventions can affect individuals,” says Clifford Goodman, PhD, vice president of The Lewin Group. “A medication that benefits a population on average does not necessarily work for everyone; it could be ineffective for some patients or harmful for others. Or, a therapy may not appear to be beneficial for the population at large, but could be very effective for one or more subgroups.” Well-designed studies with this in mind, he says, can help support high-quality, evidence-based decisions for optimal patient care at both a population and an individual level.
This desired alignment is a two-way street, notes Goodman. “Achieving this synergy means that genomic testing and other interventions used in personalized medicine will have to meet higher evidence hurdles that increasingly apply across many health technologies in the U.S. and globally.” Also, realizing the benefits of CER and personalized medicine depends on wider adoption of health information technology.
The report cites encouraging early signs for CER and personalized medicine alignment, including certain provisions in pending health reform legislation, evolving approaches to clinical trial design and data mining, methods development supported by the Agency for Healthcare Research and Quality, and certain CER priorities recommended recently by the Institute of Medicine and Federal Coordinating Council for Comparative Effectiveness Research. However, the report strongly emphasizes that much work is needed to ensure that these signs will actually lead to evidence-based personalized medicine.
The report is being delivered at the conference on "Comparative Effectiveness Research and Personalized Medicine: Science, Policy and Business," hosted by the National Pharmaceutical Council and the Personalized Medicine Coalition at The Ritz-Carlton, Pentagon City in Arlington, VA on October 28.