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Comparative effectiveness research and personalized medicine: catalyzing or colliding?
Robert S Epstein1, J Russell Teagarden
1Department of Medical and Analytical Affairs, Medco Health Solutions, Inc., Franklin Lakes, New Jersey, USA.
Comparative Effectiveness Research (CER) can advance personalized medicine by adopting new data and analytical methods. This requires adapting drug assessment processes and equipping clinicians with health IT for informed decision-making.
Area of Science:
- Health Services Research
- Pharmacogenomics
- Clinical Trial Design
Background:
- Growing interest in Comparative Effectiveness Research (CER) for drug technology assessment.
- Federal initiatives like ARRA and PCORI support CER expansion.
- Debate exists on CER's role in personalized medicine.
Purpose of the Study:
- To explore how CER can catalyze personalized medicine.
- To identify necessary adaptations in research and clinical practice for integrating CER and personalized medicine.
- To present examples of CER studies in personalized medicine.
Main Methods:
- Conceptual analysis of CER and personalized medicine integration.
- Description of two private-sector funded CER studies evaluating personalized medicine interventions.
- Focus on pharmacogenomic testing for warfarin and clopidogrel/prasugrel comparative outcomes.
Main Results:
- CER can accelerate personalized medicine adoption.
- New data sources and analytical approaches are crucial for researchers.
- Adaptations in drug technology assessment and clinician education are necessary.
Conclusions:
- Integrating CER into personalized medicine requires embracing novel methodologies and data.
- Health information technology is vital for disseminating CER findings to clinicians.
- Successful implementation necessitates changes in research, assessment, and clinical practice.
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