Abstract
The Green Park Collaborative (GPC) and the Molecular Evidence Development Consortium (MED-C) are launching a joint effort to advance personalized medicine by harmonizing standards for next-generation sequencing (NGS)-based cancer registries and databases.
“For the promise of genomic medicine to be realized in oncology, massive quantities of data on cancer phenotypes, genotypes, treatments, and outcomes must be gathered, sorted, and analyzed,” said Sean Tunis, CEO of the Center for the Medical Technology Policy, which initiated the GPC. “While a number of genomics registries and repositories have been initiated or are under development, their value to improve cancer research and patient care will be significantly increased if their respective databases can be aggregated.”
“Stakeholders increasingly recognize that all cancer genomics repositories should share basic common elements, definitions, and standards to allow data pooling for maximum analytical power,” added Dane Dickson the CEO of MED-C. “Doing so will accelerate knowledge generation for genomic medicine and provide an enhanced evidence base for decisions on coverage of clinical genomic testing and treatment for cancer.”
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“With the rapid proliferation of cancer registries we need to make sure that all NGS and clinical data can be uniformly collected and aggregated, so that it will have value for our healthcare system,” emphasized Michael Kolodziej, M.D., national medical director, oncology solutions, office of the chief medical officer at Aetna.
GPC convened a series of meetings on barriers to covering NGS in oncology. The series began with a workshop on clinical utility in July 2014 and continued through June of last year. Based on these discussions, in August of 2015, GPC issued coverage guidelines, concluding that 5 to 50 NGS cancer testing panels were no longer “investigational” and should be covered under certain circumstances by all U.S. health plans. GPC also called for enhanced data collection to support coverage decision-making by health plans. In late 2015, the MED-C engaged key stakeholders to begin work on data collection standards.
In 2016, GPC will work with MED-C and other major groups that are developing cancer genomics repositories, including ASCO, AACR, EORTC, and the NCI, to review data standards currently employed by repositories and identify commonalities to promote cross-database compatibility. GPC will also seek to develop a core set of clinical data elements that all such repositories should collect. These efforts will make it possible to aggregate key data across repositories for more powerful analyses, explained a GPC official.