NIH Advised to Recruit 1M for Precision Medicine Initiative

Troy Brown, RN

September 18, 2015

A group of technology and science experts hopes to recruit at least one million individuals to the Precision Medicine Initiative (PMI), designed to enhance innovation in biomedical research and ultimately move the United States into an era where medical treatment is tailored to each patient.

On January 20, 2015, in his State of the Union speech, President Barack Obama announced his plan to start the PMI "to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthier."

On September 17, The PMI Working Group issued its recommendations to the National Institutes of Health for achieving this goal.

The authors define precision medicine as an approach to disease treatment and prevention that attempts to maximize effectiveness by considering individual variability in genes, environment, and lifestyle.

"Precision medicine endeavors to redefine our understanding of disease onset and progression, treatment response, and health outcomes through the more precise measurement of potential contributors — for example, molecular measurements as captured through DNA sequencing technologies or environmental exposures or other information captured through increasingly ubiquitous mobile devices," the authors explain.

Precision medicine "will lead to more accurate diagnoses, more rational disease prevention strategies, better treatment selection, and the development of novel therapies."

Along with the advancement of medical science is a changing view that clinicians should engage individuals as partners and not simply as patients or research subjects.

Precision Medicine Has Seen Early Success

Examples of precision medicine that are already in use include the development of targeted therapies for cancer and cystic fibrosis that work in patients who share an underlying causal genotype.

Clinicians are using knowledge of how different polymorphisms predict an individual's response to drugs to optimize therapies, and individual genome sequencing allows for diagnosis of previously undiagnosed genetic diseases.

In addition, scientists are using molecular profiling of affected tissues to define new subtypes of diseases. This advance "is expected to lead to more focused design and testing of both therapeutic and preventative strategies — for example, treatments for specific subtypes of a disease, or behavioral interventions tailored to specific subgroups of the population," the report authors write.

One Million Participants Over 4 Years

The PMI Cohort Program will develop a large research cohort of at least one million Americans over 4 years that will provide the basis for expanding knowledge of precision medicine approaches.

The program will allow participants to volunteer and will also enable healthcare provider organizations to recruit participants. Participants will undergo physical examinations and the collection of biospecimens that may include blood, microbiome specimens, and nail and hair clippings. Specimens "will be sent to a central biorepository, which will support collection, processing, storage, retrieval and biochemical analysis and/or shipment to analytic laboratories," the report authors explain.

The PMI will need interoperable software and computing technology innovation because of the memory and storage demands related to genomic data.

The report authors want the initiative to recruit a diverse set of individuals, and they note that specific groups including children, the elderly, and prisoners will require special policy accommodations regarding informed consent.

The authors strongly recommend that patients have "optional access to the stores of data and research results based on their genomic, clinical, and claims data."

The authors believe that the combination of a highly engaged population and improved data collection "will usher in a new and more effective era of American healthcare."

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