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Oncology resources

Best Practices for the Design, Implementation, Analysis, and Reporting of Oncology Trials with High Rates of Treatment Switching
GPC released a report that provides guidance for researchers who lead oncology drug trials that may involve substantial treatment switching. Treatment switching most often occurs when a patient moves from the control to the experimental group during a clinical trial ' for example, because the patient 's disease has progressed and they want to try the experimental treatment.
Webinar: Initial Medical Policy and Model Coverage Guidelines
November 24, 2015, the Green Park Collaborative (GPC) hosted a webinar on policies for Next Generation Sequencing in Oncology.
Evaluating the comparative effectiveness of treatment sequences in oncology: a new approach
Messner DA, Towse A, Mohr PE, Garau M. The future of comparative effectiveness and relative efficacy of drugs: an international perspective. J Comp Eff Res. 2015;4(4):419-27. doi:10.2217/CER.15.6. PMID: 25730094. ISSN: 2042-6305.
Next Gen Sequencing in Clinical Oncology: Phase 2 Overview
Following the issuance of initial guidelines for NGS coverage in August 2015, GPC-USA is embarking on a Phase 2 project to map out and implement the specific arrangements, relationships, and standards needed for a system for encouraging coverage of NGS-based tests and treatments for cancer patients.
Initial Medical Policy and Model Coverage Guidelines for Clinical NGS in Oncology
The Green Park Collaborative has issued initial Guidelines for Health Insurance Coverage of Next Geration Sequencing (NGS) Testing in Oncology. We invite you to review the report (PDF on the right).
Recommendations for Comparing Therapeutic Sequences for Patients with Breast, Kidney, and Other Advanced and Metastatic Cancers (Aug 2015)
This EGD provides recommendations to use real-world data sources in studies to compare sequences of therapies in areas of advanced and metastatic cancer where a range of therapeutic options exist but evidence is lacking on the optimal choices for sequential or combination therapy. The focus is on settings where the expected outcome of therapy is not a cure since patient decisions in these settings often involve negotiation of more complex tradeoffs than in curative settings 'tradeoffs in which factors other than overall survival may have heightened importance. Metastatic breast cancer and renal cell carcinoma served as example disease areas for developing this EGD, but this approach may be relevant for other incurable cancers as well. The EGD recommends the analysis of novel outcomes and suggests ways that existing data sources should be enhanced for more robust research studies of this type.
Demonstrating the Clinical Utility of Next Generation Sequencing in Clinical Oncology
The Green Park Collaborative convened a multi-stakeholder meeting July 7, 2014 to discuss the methods and standards for evaluation of the clinical utility of next generation sequencing (NGS)-based testing in oncology. This meeting kicked off a series of discussions that will take place through the spring of 2015 and will culminate in the creation of an Effectiveness Guidance Document.
Panel Discussion: What are the Evidence Gaps Affecting Clinical Use of Next Generation Sequencing Tests in Oncology?
This panel discussion reviewed the evidence gaps affecting clinical use of next generation sequencing tests in oncology? Patricia Deverka was the moderator. Participants included Alberto Gutierrez, FDA, Elaine K. Jeter, Palmetto GBA, Robert Lechleider, United States Diagnostics Standards, Gary Lyman, Duke Cancer Institute, Sarah L. Zimmerman, Illumina, Inc.
Oncology Consortium Update
Progress Update on the GPC-USA Oncology Consortium presented at the 2014 Annual Meeting by Donna Messner, CMTP.
Oncology Overview (2013)
Part of GPC-USA, the Oncology Consortium will develop methodological standards for research research in oncology.
Development of an EGD for Patient Reported Outcomes in Oncology (May 2013)
Ethan Basch, MD, and Amy Abernethy, MD gave this presentation at the Inaugural Green Park Collaborative meeting.
Evaluation of Clinical Validity and Utility of Actionable Molecular Diagnostic Tests in Adult Oncology (May 2013)
While molecular diagnostics offer tremendous promise for improving health and offsetting costs in the oncology setting, the benefits and harms of testing are often not well known in terms that are meaningful to stakeholders. This EGD serves to close the gap between the presumed benefits of tests undergoing technology assessments and the information needs of payers, clinicians and patients. We provide specific recommendations for designing studies to evaluate the clinical validity and utility of 'actionable ' MDx tests, meaning those tests intended to guide clinical decision-making for patients with a known diagnosis of cancer.
Proposed Recommendations for Designing Clinical Trials for 'New Indications ' of Approved Oncology Drugs for Treatment of Late Stage Disease (September 2012)
This EGD provides a framework to guide the design and implementation of prospective clinical trials for FDA-approved oncology drugs used outside their current labeled indications to treat late stage cancer.
Recommendations for Incorporating Patient-Reported Outcomes into Clinical Comparative Effectiveness Research in Adult Oncology (May 2012)
This EGD provides recommendations to set a minimum standard that will ensure that data collection allows for examination of patients ' directly reported experiences in diverse studies of treatment effectiveness and outcomes in oncology.
ATHENA Breast Health Network
This partnership seeks to revolutionize breast cancer care and molecular diagnostics by merging research, technology, financing and health care delivery to reduce the time needed to translate research findings into patient care. CMTP led the Biomarker Stakeholder Advisory Group, developed a business plan for sustainable partnerships between ATHENA and other health care stakeholders, and advised on proposed CER projects to identify best treatments for women with low, medium and high-risk breast tumors.
2010 CER Summit
A summary of the 2010 CER Summit which addressed building a strategic framework for research in oncology.
National Radiation Oncology Registry (NROR)
CMTP is advising on the development of this registry, which will enable the rapid comparison of traditional and patient reported outcomes that result from various radiation treatment approaches.
Designing More Informative Clinical Trials for New Indications of Oncology Drugs, November 2009
CMTP hosted a one day Think Tank on November 12, 2009 with more than 60 experts and stakeholders to reach consensus on better ways to more frequently and consistently design, fund, and implement prospective clinical studies of new indications for oncology drugs that will be more informative to post-regulatory decisionmakers.
Gene Expression Profile Tests for Early Stage Breast Cancer (released June 2009)
This Evidence Guidance Document provides clinical researchers and product developers with guidelines for the design of studies that meet the evidence requirements of health care decision-makers on gene expression profile tests.

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Oncology resources

Best Practices for the Design, Implementation, Analysis, and Reporting of Oncology Trials with High Rates of Treatment Switching

Webinar: Initial Medical Policy and Model Coverage Guidelines

Evaluating the comparative effectiveness of treatment sequences in oncology: a new approach

Next Gen Sequencing in Clinical Oncology: Phase 2 Overview

Initial Medical Policy and Model Coverage Guidelines for Clinical NGS in Oncology

Recommendations for Comparing Therapeutic Sequences for Patients with Breast, Kidney, and Other Advanced and Metastatic Cancers (Aug 2015)

Demonstrating the Clinical Utility of Next Generation Sequencing in Clinical Oncology

Panel Discussion: What are the Evidence Gaps Affecting Clinical Use of Next Generation Sequencing Tests in Oncology?

Oncology Consortium Update

Oncology Overview (2013)

Development of an EGD for Patient Reported Outcomes in Oncology (May 2013)

Evaluation of Clinical Validity and Utility of Actionable Molecular Diagnostic Tests in Adult Oncology (May 2013)

Proposed Recommendations for Designing Clinical Trials for 'New Indications ' of Approved Oncology Drugs for Treatment of Late Stage Disease (September 2012)

Recommendations for Incorporating Patient-Reported Outcomes into Clinical Comparative Effectiveness Research in Adult Oncology (May 2012)

ATHENA Breast Health Network

2010 CER Summit

National Radiation Oncology Registry (NROR)

Designing More Informative Clinical Trials for New Indications of Oncology Drugs, November 2009

Gene Expression Profile Tests for Early Stage Breast Cancer (released June 2009)