Precision Medicine: Potentially Transformative, but Facing Many Challenges

Precision medicine is an emerging approach to disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.

The idea is precision medicine allows clinicians to provide the right treatment at the right time and deliver healthcare more accurately and efficiently, which leads to better quality of care.

“Precision medicine has the potential to transform medicine by tailoring treatments to individuals,” Victor J. Dzau, MD, president of the National Academy of Medicine in Washington, DC, and Geoffrey S. Ginsburg, MD, PhD, of the Duke University Center for Applied Genomics & Precision Medicine in Durham, NC, wrote in a JAMA Viewpoint article.

However, significant challenges exist before precision medicine can be broadly implemented in healthcare, among them insufficient evidence generation, data sharing, and infrastructure challenges, slow uptake of genomic information into clinical care and research, the economics of precision medicine, and achieving greater patient and clinician engagement and trust in precision medicine.

To realize the promise of precision medicine, the authors suggested what they term 5 Vital Directions that require priority consideration:

1. Develop evidence of the benefit of precision medicine. There must be a robust evidentiary framework for the evaluation of evidence about its benefit on outcomes if clinicians, patients, healthcare organizations, and regulators are to adopt precision medicine.
2. Accelerate the integration and assessment of clinical data. “Advancing precision medicine and achieving a greater understanding of the complexities of human health and disease will require accessibility and alignment of large-scale, detailed data, often unstructured into a comprehensive knowledge network,” the authors wrote.
3. Promote the integration of molecular guidance into care. Medicine needs to adopt an approach that considers a patient’s genome sequence foundational information for healthcare.
4. Develop innovation-oriented reimbursement and regulatory frameworks because the current reimbursement environment does not reward innovators for the value created by their diagnostic tests. Reimbursement for diagnostics is typically cost based, which discourages the translation of innovative tests and therapies. Incentives will be crucial for developing the evidence base and economic model supporting precision medicine, the authors say.
5. Strengthen engagement and trust the public, because these are essential elements of precision medicine research. Precision medicine requires partnerships between the research and clinical communities and the public if it is to be successful.

Effective implementation of each of these Vital Directions will require stronger individual and community engagement, the authors advised, along with smooth coordination and collaboration among stakeholders from the public, private, academic, and government sectors. They noted that trust is an essential element for discovery in precision medicine to be accelerated and adopted.

President Obama announced a Precision Medicine Initiative in his 2015 State of the Union address. The initiative was launched with a $215 million investment in the president’s 2106 budget.