GPC and MED-C Launch Joint Effort to Harmonize Standards for NGS Registries and Databases
January 12, 2016
GPC and the MED-C are launching a joint effort to advance personalized medicine by harmonizing standards for Next Generation Sequencing (NGS)-based cancer registries and databases.
Baltimore, Maryland (January 12, 2016) – 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 CMTP. “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,” said 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.”
“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,” said Mike Kolodziej of Aetna.
GPC convened a series of meetings on barriers to covering NGS in oncology. The series, which included representatives of major national payers, industry, patients, guideline developers, professional societies, and others, began with a workshop on clinical utility in July 2014 and continued through June of 2015. 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 clinical circumstances by all US health plans. GPC also recommended the need for enhanced data collection to support coverage decision-making by health plans. In late 2015, the MED-C engaged a number of key stakeholders to begin work on developing data collection standards for genomic medicine.
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.
GPC is a multi-stakeholder forum focused on improving clinical evidence and policies for health plan reimbursement. GPC, a major initiative of the Center for Medical Technology Policy (CMTP), convenes working groups to develop condition and technology-specific study design recommendations that focus on real-world effectiveness and value, meet the evidence expectations of payers, and are informed by the views of patients and clinicians.
The mission of the MED-C is to focus key stakeholders to build infrastructure and projects to rapidly accelerate precision medicine. MED-C’s initial effort is a prospective observational registry collecting standardized next-generation sequencing and clinical outcomes in oncology. This registry will facilitate entry into clinical trials for both targeted therapy as well as more advanced testing of deeper molecular layers. Further projects will expand into non-oncology areas of molecular medicine as well as exploring new technologies and application. MED-C is a 501(c) non-profit organization.