Lewin Group Report Urges Alignment of Comparative Effectiveness Research and Personalized Medicine

Actions specified to emphasize new evidence for subgroups and individuals, not
just population averages
FALLS CHURCH, Va.--(Business Wire)--
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. 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.

For more information, visit www.lewin.com/CER.

About The Lewin Group Center for Comparative Effectiveness Research
The Lewin Group Center for Comparative Effectiveness Research manages, conducts,
interprets and supports the use of CER to make informed decisions regarding
patient outcomes, health care policy and the optimal use of health care
resources. It is part of The Lewin Group, a premier national health care and
human services consulting firm that has delivered objective analyses and
strategic counsel to prominent public agencies, nonprofit organizations,
industry associations and private companies across the United States for nearly
40 years.

The Lewin Group is widely recognized for its expertise in the U.S. health care
system, its record in health technology assessment and evidence-based medicine;
health care policy and other issues, and its independence and objectivity. The
Center combines these strengths with the unique capabilities of our sister
company, i3, in clinical trials and study design, health economics and outcomes
research; and through Ingenix, access to one of the world`s largest and most
robust patient data sets including de-identified, integrated diagnosis, medical,
and pharmacy claims data for millions of individuals. Learn more at
www.lewin.com/CER.

In keeping with our tradition of objectivity, The Lewin Group is not an advocate
for or against any legislation. The Lewin Group is part of Ingenix, Inc., which
is a wholly owned subsidiary of UnitedHealth Group. To assure the independence
of its work, The Lewin Group has editorial control over all of its work
products. Go to www.lewin.com/integrity for more information.

The Lewin Group Center for Comparative Effectiveness Research
Gregory Butera, 703-269-5548
Cell: 202-345-3681
gregory.butera@lewin.com
www.lewin.com

Copyright Business Wire 2009