Improving the Quality of 'Personalized Medicine' Research and Practice

Through an Ethical Lens

George P Browman; Jochen Vollmann; Alice Virani; Jan Schildmann

Disclosures

Personalized Medicine. 2014;11(4):413-423. 

In This Article

Conclusion & Future Perspective

We have opted to take a particular perspective on improving the quality of PM for the future by accepting the vision of the future of PM as an integrated system within a learning healthcare environment. Our main theme is that attention to quality maintenance and improvement in PM from a systems' perspective will need to include ethical as much as laboratory-based analytical and clinically based methodological considerations. Quality attributes such as accessibility, effectiveness, affordability, sustainability and transparency for public confidence and effective partnerships are crucial issues, beyond clinical- and laboratory-based validity concerns. These quality attributes will need to be considered together and therefore informed by a strong ethical framework that addresses equally individuals' and societal rights. Whether existing frameworks will serve the PM systems agenda well, or whether new ethical solutions will be needed is a matter for serious exploration.

Using as examples how we market fairly the potential benefits and limitations of PM, the potential role of industry and new partnerships, value judgments in the context of research methodology, the advent of advanced communications and genomics technologies, as well as the implications of personalized (genomic) medicine policies we demonstrate how important it is to consider the downstream direct and indirect consequences of these developments from an ethical perspective. Attention to ethical considerations needs to be part and parcel of quality improvement strategies for the current and future health of PM.

We view the key next steps in the evolution of PM as: redefining the characteristics of PM more broadly to contribute to quality assessment of its performance across complementary quality dimensions, including ethics; defining and raising ethical standards in PM performance assessment to a level that is equal to our traditional scientific quality principles of validity, reproducibility and utility; developing evaluation frameworks of PM quality performance from a systems perspective; developing a framework that clearly positions PM as a systems level issue; and developing a framework to facilitate negotiations of a governance model among stakeholders with financial and other interests in a PM system but with incompletely aligned objectives. A key part of addressing the governance and operational issues will be how to effectively incorporate the public/patient voice in the evolution of PM and how to achieve transparency with respect to the tradeoffs that will be needed to satisfy competing interests of multiple stakeholders.

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