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NIH Sep 5, 2008 | R01
Pharmacogenetic Testing: Challenges of Clinical Integration
Institution: DUKE UNIVERSITY
FOA Number: PA-08-012
Abstract
Pharmacogenetic testing is considered one of the most promising clinical applications arising from genomics research, with the potential to reduce adverse drug responses and improve efficacy of drug treatment. Because pharmacogenetic tests address a specific question about drug therapy, they have generally been viewed as having fewer ethical and social implications than other types of genetic testing. Yet some policy concerns will need to be addressed before pharmacogenetic tests can be introduced appropriately into clinical practice. A key concern is the potential for pharmacogenetic tests to generate ancillary clinical information unrelated to the drug treatment question for which testing is done - an informational 'side effect.' The ancillary information generated by pharmacogenetic tests is variable, and may include information about disease predispositions, prognosis, and drug responses other than those for which testing is performed. For example, testing for statin response might reveal information about risk of Alzheimer's disease or macular degeneration. These issues raise several questions: What would a reasonable person want to know about the scope of testing and access to test results? Should information about other potential uses of a test result be made available to the patient? Which health care professionals should routinely have access to pharmacogenetic results? This project will explore these policy challenges through the following specific aims:
1) determine the legal obligations of health professionals with respect to sharing of pharmacogenetic information and disclosure of ancillary clinical information;
2 & 3) assess attitudes of the public and health professionals toward disclosure of different types of ancillary information related to pharmacogenetic testing and related issues of informed consent, counseling, and sharing of pharmacogenetic information among health professionals through focus groups and surveys, and
4) develop a stakeholder consensus regarding appropriate policies for counseling, informed consent and disclosure of ancillary information related to pharmacogenetic testing.
PUBLIC HEALTH RELEVANCE - The results of this study will help to ensure the appropriate clinical integration of pharmacogenetic testing, and inform related issues arising with the increasing use of genetic testing for the general population, including risk communication and the appropriate roles of health professionals as we enter the era of genomic medicine in the US. This study will also help inform determinations of whether new health infrastructures for pharmacogenetics are required beyond current systems for successful population-wide integration.
FUNDING AGENCY:
Funder:
NIHInstitute:
NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCESFunding Type:
R01Project Number:
R01GM081416Start Date:
Sep 5, 2008End Date:
Aug 31, 2011PROJECT TERMS:
Adherence, Adverse effects, Adverse event, Adverse reactions, Affect, Age, Attention, Attitude, Awareness, base, Caring, Chronic, Clinical, clinical care, clinical practice, Consent, cost, Data Collection, Decision Making, dosage, Dose, Drug Prescriptions, Drug Targeting, Economics, Education, Educational Intervention, Effectiveness, Evaluation, Event, experience, follow-up, General Population, Genetic, Genetic Predisposition to Disease, Happiness, improved, Individual, information seeking behavior, interest, Intervention, Intranet, Knowledge, Learning, Light, Managed Care, Measures, Medical, medication compliance, Methods, Modeling, Monitor, Office Visits, Outcome, Outpatients, Parents, Patients, Perception, Pharmaceutical Preparations, Pharmacists, pharmacogenetic testing, Pharmacogenetics, pharmacy benefit, Physicians, Policy Maker, Primary Care Physician, Primary Health Care, Process, Product Labeling, Provider, Quality of Care, Recommendation, response, Risk, Safety, satisfaction, Savings, Self-Administered, sound, Surveys, Test Result, Testing, Therapeutic, Time Study, Treatment Efficacy, uptake, Work, Workload