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Applied Clinical Trials
PCORI underscored existing trends toward increasingly individualized and personalized medical care...
Editor’s Note: This article is part of a series examining popular peer-reviewed articles from years past called “Peer-Reviews Revisited: Why You Should Read Today.” You can read the other articles in this series here.
The 2010 Patient Protection and Affordable Care Act authorized the creation of the Patient-Centered Outcomes Research Institute. PCORI underscored existing trends toward increasingly individualized and personalized medical care, and required research protocols to include various subpopulations such as racial and ethnic minorities, women, age, and comorbidities, genetic and molecular subtypes, and quality of life preferences.
“This requirement presents the potential to discover and disseminate crucial comparative effectiveness research findings that individual patients and their clinicians need for making informed health-care decisions,” said Kathleen Wyrwich, PhD, Senior Research Leader at Evidera Outcomes Research Group, Bethesda, MD. Dr. Wyrwich is also lead author of an examination of “Personalized Healthcare” that appeared in Applied Clinical Trials based on a panel discussion at the International Society for Pharmacoeconomics and Outcomes Research annual meeting in 2011.
“Healthcare providers and systems know race, ethnicity, sex, age, comorbidity status, and other relevant information for patients,” she added. “A more holistic definition of precision or personalized healthcare can now be considered, the promise of knowing which interventions are most effective for which patients and under what circumstances. [It] also incorporates the personal needs, preferences, healthcare access, and adherence attributes that each person brings to the healthcare encounter in addition to genomic information.”
Discussants offered key perspectives on the need for and development of personalized medicine.
Generics have become the standard of care for many diseases. Trial sponsors must identify and target subpopulations that are less than optimally responsive to existing agents or may be at increased risk due to specific genetic, molecular, or other individual factors.