PMC Report Proposes Strategies for Clinical Integration of Personalized Medicine

The Health Care Working Group (HWG) of the Personalized Medicine Coalition (PMC) has published a new report that provides a framework for the successful integration of personalized medicine in the clinic.

Several programs, including those instituted by the CDC (Evaluation of Genomic Application in Practice and Prevention program), the Human Genome Research Institute (Implementing Genomics in Practice Network), and the Electronic Medical Records and Genomics Network, were designed to address the use and implementation of genomic information in electronic health records to inform clinical decisions. Despite these efforts, healthcare institutes may not be best prepared to translate the accumulated genomic information into the clinic.

PMC’s HWG—which includes representatives from 49 healthcare delivery groups—identified a few common challenges faced when implementing a personalized medicine program, and supported the findings with suitable strategies that hospitals and healthcare institutions could use to resolve the barriers. Following a series of focus group discussions and a national meeting, 5 general challenge areas were identified:

• Education and awareness
• Patient empowerment
• Value recognition
• Infrastructure and information management
• Ensuring access to care

While the working group acknowledged the differences in the challenges faced are steered by the site of care, with community clinics facing a different set of challenges compared with a hospital or an academic center. The following general strategies were recommended by the HWG:

Education and awareness. The group has recommended keeping stakeholders abreast of the developments in the field, using resources that match their needs—a “personalized” approach to education. Howvever, it warns that the sources should be accurate, trusted, and updated regularly. PMC is working to create such a resource. Another recommendation is to develop a common terminology regarding personalized medicine and to engage community leaders, patient support groups, and healthcare delivery professionals to get the information out.

Patient empowerment. Protecting patient privacy is important, and the working group recommends that patients be fully informed of ways that their health information can be completely protected, particularly when this information is shared by multiple specialized physicians. There are several ongoing efforts on this front that are trying to update policies on informed consent for participation in clinical research, which includes providing genetic counseling services to patients and their families.

Value recognition. Creating a value proposition for how this information is beneficial for payers and healthcare systems would have a significant impact on moving this effort forward. The working group suggests that manufacturers can provide customized evidence reports that include economic and clinical risk reduction end points. The HWG also recommends the creation of a learning health system for providers and payers to collect and share treatment and outcomes data.

Infrastructure and information management. The group emphasizes the importance of creating systems that can manage the massive amount of information associated with personalized medicine, as well as for coordinating the associated services, to enable a meaningful impact on the broader healthcare system. This calls for developing transparent partnerships between healthcare delivery systems and information management organizations. To this end, electronic health records should include the patient’s genetic information with built-in clinical support tools.

Ensuring access to care. Changing the healthcare delivery approach so processes and service structures adapt a more personalized approach to care. This would essentially require a change in attitude of the care delivery personnel. The working group recommends that improving the knowledge base, empowering patients, demonstrating value across stakeholder groups, and building effective program infrastructure and information management processes are essential.

You can access the full report here.