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Purpose: The White House Cancer Moonshot Initiative aims to double the rate of progress against cancer. A component of VA’s efforts to support Cancer Moonshot is VA’s national Precision Oncology Program (POP), which aims to (1) create best practices to provide genomic testing and reporting of tumor samples from patients; (2) provide annotation of tumor molecular analysis panels and consultative services to cancer care providers; (3) facilitate access to matching approved and novel therapies; and (4) institute a learning healthcare system for administrative, clinical care and research purposes. The aspirational goal of POP is to double the survival of patients with advanced NSCLC.

Methods: Standard project management techniques and descriptive statistics were used.

Results: As of June 2016, a Director of POP and an interim advisory group have been appointed. 32 facilities have been contacted and provided an initial response. 18 facilities are enrolled in POP and have sent at least 1 tumor sample; 8 additional facilities are in the activation process. A total of 347 tumor samples have been sent for profiling through one of two vendors, including 231 lung cancer cancers and 75 melanomas. Support for annotation of tumor genetic panels is available from N-of-One and IBM Watson for Oncology. To date, 13 patients have received targeted agents after tumor panel testing including erlotinib or gefitinib (n = 5), crizotinib (n = 3), and 1 patient each for dabrafenib + trametinib, vemurafenib, olaparib, pazopanib, and sunitinib. Research partnerships with other governmental agencies, non-profit organizations, and industry are being pursued to expand access to novel therapies. “Smart” CPRS templates that structure core clinical data elements have been designed to support clinician documentation needs, POP activities, and the learning healthcare system.

Implications: Implementation of the National Precision Oncology Program at all facilities treating patients with advanced cancer is planned.

Purpose: The White House Cancer Moonshot Initiative aims to double the rate of progress against cancer. A component of VA’s efforts to support Cancer Moonshot is VA’s national Precision Oncology Program (POP), which aims to (1) create best practices to provide genomic testing and reporting of tumor samples from patients; (2) provide annotation of tumor molecular analysis panels and consultative services to cancer care providers; (3) facilitate access to matching approved and novel therapies; and (4) institute a learning healthcare system for administrative, clinical care and research purposes. The aspirational goal of POP is to double the survival of patients with advanced NSCLC.

Methods: Standard project management techniques and descriptive statistics were used.

Results: As of June 2016, a Director of POP and an interim advisory group have been appointed. 32 facilities have been contacted and provided an initial response. 18 facilities are enrolled in POP and have sent at least 1 tumor sample; 8 additional facilities are in the activation process. A total of 347 tumor samples have been sent for profiling through one of two vendors, including 231 lung cancer cancers and 75 melanomas. Support for annotation of tumor genetic panels is available from N-of-One and IBM Watson for Oncology. To date, 13 patients have received targeted agents after tumor panel testing including erlotinib or gefitinib (n = 5), crizotinib (n = 3), and 1 patient each for dabrafenib + trametinib, vemurafenib, olaparib, pazopanib, and sunitinib. Research partnerships with other governmental agencies, non-profit organizations, and industry are being pursued to expand access to novel therapies. “Smart” CPRS templates that structure core clinical data elements have been designed to support clinician documentation needs, POP activities, and the learning healthcare system.

Implications: Implementation of the National Precision Oncology Program at all facilities treating patients with advanced cancer is planned.

Purpose: The White House Cancer Moonshot Initiative aims to double the rate of progress against cancer. A component of VA’s efforts to support Cancer Moonshot is VA’s national Precision Oncology Program (POP), which aims to (1) create best practices to provide genomic testing and reporting of tumor samples from patients; (2) provide annotation of tumor molecular analysis panels and consultative services to cancer care providers; (3) facilitate access to matching approved and novel therapies; and (4) institute a learning healthcare system for administrative, clinical care and research purposes. The aspirational goal of POP is to double the survival of patients with advanced NSCLC.

Methods: Standard project management techniques and descriptive statistics were used.

Results: As of June 2016, a Director of POP and an interim advisory group have been appointed. 32 facilities have been contacted and provided an initial response. 18 facilities are enrolled in POP and have sent at least 1 tumor sample; 8 additional facilities are in the activation process. A total of 347 tumor samples have been sent for profiling through one of two vendors, including 231 lung cancer cancers and 75 melanomas. Support for annotation of tumor genetic panels is available from N-of-One and IBM Watson for Oncology. To date, 13 patients have received targeted agents after tumor panel testing including erlotinib or gefitinib (n = 5), crizotinib (n = 3), and 1 patient each for dabrafenib + trametinib, vemurafenib, olaparib, pazopanib, and sunitinib. Research partnerships with other governmental agencies, non-profit organizations, and industry are being pursued to expand access to novel therapies. “Smart” CPRS templates that structure core clinical data elements have been designed to support clinician documentation needs, POP activities, and the learning healthcare system.

Implications: Implementation of the National Precision Oncology Program at all facilities treating patients with advanced cancer is planned.

The VA recently launched the Precision Oncology Program (POP), a clinical program that provides a turnkey operation for targeted sequencing of tumor samples and return of annotated results to the patient record. The Program recommends available clinical trials and consultative advice to clinicians and patients. We describe here the accompanying Research Program (Re-POP) that leverages the artifacts of the POP.

Lung cancer patients whose tumors are sequenced as part of the clinical POP will be given the opportunity to participate in the research Program. The goals of the Re-POP include: 1) creation of a network of VA sites to participate as a consortium in clinical trials; 2) provision of a research data repository containing information regarding tumor features including mutational status, patient demographics, and cancer treatments and outcomes; and 3) re-use of residual patient tumor tissue for expanded analysis.

Through collaborative efforts with research groups Re-POP will open large trials on a national level throughout the VA. Use of a centralized IRB and coordinating center (at Massachusetts Veterans Epidemiology Research and Information Center) will facilitate opening studies at any VA site that wishes to participate. The VA Cooperative Studies Program will support these activities. Preliminary data suggest that the Program can make available protocols offering either experimental or off-label therapies for approximately half of all nonsmall cell lung cancer patients.

The Re-POP data repository will reside at the NCI Genomic Data Commons and is available to both academic and industry researchers. Predictive analytics of these data support learning healthcare system activities (predicting individual patient outcomes) and the production of population-level generalizable knowledge.

Residual tissue and clinical data from Re-POP will be made available to researchers to identify new biomarkers that will enhance understanding of response to therapies as well as identify new therapeutic targets. An NCI-VA-DoD collaboration to study the value of proteomics in predicting response to targeted therapies in lung cancer was recently announced as part of the White House’s cancer moonshot initiative.

The VA recently launched the Precision Oncology Program (POP), a clinical program that provides a turnkey operation for targeted sequencing of tumor samples and return of annotated results to the patient record. The Program recommends available clinical trials and consultative advice to clinicians and patients. We describe here the accompanying Research Program (Re-POP) that leverages the artifacts of the POP.

Lung cancer patients whose tumors are sequenced as part of the clinical POP will be given the opportunity to participate in the research Program. The goals of the Re-POP include: 1) creation of a network of VA sites to participate as a consortium in clinical trials; 2) provision of a research data repository containing information regarding tumor features including mutational status, patient demographics, and cancer treatments and outcomes; and 3) re-use of residual patient tumor tissue for expanded analysis.

Through collaborative efforts with research groups Re-POP will open large trials on a national level throughout the VA. Use of a centralized IRB and coordinating center (at Massachusetts Veterans Epidemiology Research and Information Center) will facilitate opening studies at any VA site that wishes to participate. The VA Cooperative Studies Program will support these activities. Preliminary data suggest that the Program can make available protocols offering either experimental or off-label therapies for approximately half of all nonsmall cell lung cancer patients.

The Re-POP data repository will reside at the NCI Genomic Data Commons and is available to both academic and industry researchers. Predictive analytics of these data support learning healthcare system activities (predicting individual patient outcomes) and the production of population-level generalizable knowledge.

Residual tissue and clinical data from Re-POP will be made available to researchers to identify new biomarkers that will enhance understanding of response to therapies as well as identify new therapeutic targets. An NCI-VA-DoD collaboration to study the value of proteomics in predicting response to targeted therapies in lung cancer was recently announced as part of the White House’s cancer moonshot initiative.

The VA recently launched the Precision Oncology Program (POP), a clinical program that provides a turnkey operation for targeted sequencing of tumor samples and return of annotated results to the patient record. The Program recommends available clinical trials and consultative advice to clinicians and patients. We describe here the accompanying Research Program (Re-POP) that leverages the artifacts of the POP.

Lung cancer patients whose tumors are sequenced as part of the clinical POP will be given the opportunity to participate in the research Program. The goals of the Re-POP include: 1) creation of a network of VA sites to participate as a consortium in clinical trials; 2) provision of a research data repository containing information regarding tumor features including mutational status, patient demographics, and cancer treatments and outcomes; and 3) re-use of residual patient tumor tissue for expanded analysis.

Through collaborative efforts with research groups Re-POP will open large trials on a national level throughout the VA. Use of a centralized IRB and coordinating center (at Massachusetts Veterans Epidemiology Research and Information Center) will facilitate opening studies at any VA site that wishes to participate. The VA Cooperative Studies Program will support these activities. Preliminary data suggest that the Program can make available protocols offering either experimental or off-label therapies for approximately half of all nonsmall cell lung cancer patients.

The Re-POP data repository will reside at the NCI Genomic Data Commons and is available to both academic and industry researchers. Predictive analytics of these data support learning healthcare system activities (predicting individual patient outcomes) and the production of population-level generalizable knowledge.

Residual tissue and clinical data from Re-POP will be made available to researchers to identify new biomarkers that will enhance understanding of response to therapies as well as identify new therapeutic targets. An NCI-VA-DoD collaboration to study the value of proteomics in predicting response to targeted therapies in lung cancer was recently announced as part of the White House’s cancer moonshot initiative.

Traditional research methods, well suited for scientific discovery and drug development, fall short of providing health care systems with pragmatic information in 2 important ways: Current funding and institutions cannot support comparative effectiveness studies in sufficient numbers to answer the plethora of important clinical questions that confront health care providers (HCPs). The resultant knowledge gap manifests in treatment variability based on clinician impression rather than on direct evidence. A second equally important deficiency is the inability to make full use of the knowledge acquired in treating past patients to determine the best treatment option for the current patient.

Digitization of medical records, creation of health care system corporate data warehouses, and state-of-the-art analytical tools already allow for this revolutionary approach to patient care. Obstructing progress, however, is a lack of understanding by health care system managers and HCPs of the capability of the approach, and unfamiliarity with the requisite informatics by traditional medical researchers. Furthermore the regulatory approach is tilted against the reuse of medical record data for learning and toward strict adherence to patient confidentiality.

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Traditional research methods, well suited for scientific discovery and drug development, fall short of providing health care systems with pragmatic information in 2 important ways: Current funding and institutions cannot support comparative effectiveness studies in sufficient numbers to answer the plethora of important clinical questions that confront health care providers (HCPs). The resultant knowledge gap manifests in treatment variability based on clinician impression rather than on direct evidence. A second equally important deficiency is the inability to make full use of the knowledge acquired in treating past patients to determine the best treatment option for the current patient.

Digitization of medical records, creation of health care system corporate data warehouses, and state-of-the-art analytical tools already allow for this revolutionary approach to patient care. Obstructing progress, however, is a lack of understanding by health care system managers and HCPs of the capability of the approach, and unfamiliarity with the requisite informatics by traditional medical researchers. Furthermore the regulatory approach is tilted against the reuse of medical record data for learning and toward strict adherence to patient confidentiality.

Click here to continue reading.

Traditional research methods, well suited for scientific discovery and drug development, fall short of providing health care systems with pragmatic information in 2 important ways: Current funding and institutions cannot support comparative effectiveness studies in sufficient numbers to answer the plethora of important clinical questions that confront health care providers (HCPs). The resultant knowledge gap manifests in treatment variability based on clinician impression rather than on direct evidence. A second equally important deficiency is the inability to make full use of the knowledge acquired in treating past patients to determine the best treatment option for the current patient.

Digitization of medical records, creation of health care system corporate data warehouses, and state-of-the-art analytical tools already allow for this revolutionary approach to patient care. Obstructing progress, however, is a lack of understanding by health care system managers and HCPs of the capability of the approach, and unfamiliarity with the requisite informatics by traditional medical researchers. Furthermore the regulatory approach is tilted against the reuse of medical record data for learning and toward strict adherence to patient confidentiality.

Click here to continue reading.