Sunday, April 6, 2025
4/6/2025
Surveillance for outcomes of genomic medicine policies - PROJECT SUMMARY/ABSTRACT Patients and health care professionals are now able to use genetic information to help prevent, diagnose and select treatments for diseases. Health policies can improve or reduce access to genomic tests. Implementation of policies for genomic tests is growing rapidly but we know little about the effects of such policies. There are currently no surveillance structures in place to examine outcomes associated with policies for genomic tests. Randomized trials are generally not feasible to examine the effects of policies. Monitoring the outcomes of policies is an important public health issue. I propose to advance the field of genomic medicine research and practice by developing and validating analytical methods for efficient, rigorous evaluation of policies that could impact access to genomic tests and associated outcomes. My vision is to pioneer a new approach for efficient, rigorous evaluation of outcomes of genomic medicine policies. I will lead a team to build the foundation by adapting and validating rigorous analytical methods in a distributed data network environment that enables efficient but privacy-preserving multi-site analyses of data from large, diverse populations. We will lay the groundwork through two innovative outputs: (1) Adapt one of the strongest quasi-experimental study designs, the interrupted time series method, for novel applications: evaluation of policies for genomic tests. We will adapt the method within a renowned distributed data network of 17 health systems. No single system has sufficient data for genomic medicine. This approach allows efficient aggregation of data across sites from large, diverse populations without sharing person-level information (patient privacy-preserving); and (2) Showcase and refine our analytical methods by using a test case: we will evaluate the consequences of Medicare’s coverage of next-generation sequencing for patients with recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer. Our approach will have broad applicability for other policies for genomic tests and/or related services. The United States, as the world’s leader in precision medicine, has a vital stake in analytical tools for assessing rigorously and efficiently the effects of policies for genomic tests—a much-needed resource for patients, clinicians, policymakers who seek to maximize individual and population health through the integration of genomic medicine into healthcare policy and practice.
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