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NIH; and $400 million for the Offi ce of the Secretary of Health and Human Services.
A report by the Federal Coordinating Council for Comparative Effectiveness
Research, which was created by the ARRA, proposed that comparative effective-
ness should complement the trend in medicine to develop personalized medicine,
and should use the ability to investigate drug and dosage effects at the sub-group
level in ways that are diffi cult in randomized trials.
AHRQ provided $100 million in stimulus funding in 2010 to support studies of
the effectiveness of treatments and diagnostics, including personalized healthcare
approaches, such as pharmacogenetics, clinical diagnostics, and bio-imaging stud-
ies. The projects entailed a range of approaches, including prospective studies that
explore the outcomes of pharmacogenetic testing in guiding selection of therapeutic
interventions, evaluation of new imaging technologies to diagnose or monitor treat-
ments, and prospective and longitudinal cohort studies of effectiveness and com-
parative effectiveness of diagnostics, devices, and drugs. As a unit of the DHHS
dedicated to advancing excellence in health care, AHRQ has the following two
programs dedicated wholly or in part to personalized medicine.
Evidence-Based Practice Centers (EPCs) These centers review all relevant scien-
tifi c literature on clinical, behavioral, and organization and fi nancing topics to pro-
duce evidence reports and technology assessments. These reports are used for
informing and developing coverage decisions, quality measures, educational mate-
rials and tools, guidelines, and research agendas. EPCs also conduct research on
methodology of systematic reviews. AHRQ awards 5-year contracts to institutions
in the US and Canada to serve as EPCs.
Centers for Education and Research on Therapeutics (CERTs) These are part of a
national initiative to conduct research and provide education that advances the opti-
mal use of therapeutics (drugs, medical devices, and biological products). The pro-
gram consists of 14 research centers and a coordinating center and is funded and run
as a cooperative agreement by AHRQ in consultation with the FDA.
Comparative Effectiveness Research
Due to numerous advances in biomedical science, clinicians and patients often have
a plethora of choices when making decisions about diagnosis, treatment, and pre-
vention, but it is frequently unclear which therapeutic choice works best for whom,
when, and in what circumstances. Comparative effectiveness research (CER) is the
conduct and synthesis of research comparing the benefi ts and harms of different
interventions and strategies to prevent, diagnose, treat and monitor health condi-
tions in “real world” settings. The purpose of this research is to improve health
outcomes by developing and disseminating evidence-based information to patients,
clinicians, and other decision-makers, responding to their expressed needs, about
which interventions are most effective for which patients under specifi c circum-
stances. To provide this information, comparative effectiveness research must assess
20 Development of Personalized Medicine