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Green Park Collaborative resources

Designing Late Phase Clinical Trials of Disease-modifying Agents to Delay or Prevent Dementia due to Alzheimer 's Disease
This document reports on a project conducted by the Center for Medical Technology Policy 's Green Park Collaborative to create multi-stakeholder vetted recommendations for the design of studies in later phases of drug development to evaluate the ability of disease-modifying agents to delay or prevent the onset of dementia due to Alzheimer 's disease.
coreHEM: Developing Comparative Effectiveness Outcomes for Gene Therapy in Hemophilia
coreHEM has produced the first set of guidelines recommending a specific, minimum set of outcomes to include in hemophilia gene therapy clinical trials. This core set will ensure that patient perspectives on critical outcomes are included in pivotal trials, allow fair comparisons between alternative treatments, and allow more accurate assessments of the value of these therapies. The coreHEM project was jointly led by the Green Park Collaborative (GPC), the National Hemophilia Foundation (NHF), and McMaster University.
A Multi-Pronged Strategy to Improve the Relevance, Usefulness, and Comparability of Outcomes in Clinical Research
Developed through multi-stakeholder discussions, this white paper outlines major challenges and considerations for development and utilization of core outcome sets (COS) in clinical research, and identifies potential solutions to these challenges.
CAP Accreditation Standards and Proficiency Testing for Diagnostic Next Generation Sequencing
The Green Park Collaborative (GPC) hosted a webinar on the College of American Pathologists' (CAP) Accreditation Program for Next Generation Sequencing (NGS).
Genomic Technologies Forum Meeting Briefing
New Genomic Technologies in Clinical Medicine: Current Evidence and Decision-Making; Summary and Highlights from the 2017 Green Park Collaborative Genomic Technologies Forum
RWE Decoder: A Practical Tool for Assessing Relevance and Rigor of Real World Evidence
GPC developed a tool to help healthcare decision makers confidently and consistently use Real World Evidence (RWE) when making tough coverage and care choices.
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.
Methods for Evaluating the Comparative Effectiveness of Interventions for Obesity and Overweight
Summary of January 2015 Workshop
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.
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).
Highlights of the 2015 Annual GPC Meeting
The Green Park Collaborative convened its 2015 Annual Meeting April 30, 2015. Here are highlights from the day.
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.
Green Park Collaborative Annual Progress Report 2015
This report shows the Green Park Collaborative's 2015 accomplishments, as well as upcoming initiatives.
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.
Recommendations for Late Phase Drug Studies in Type 2 Diabetes (July 2014)
The EGD provides guidance for improving the design, conduct, and reporting of late phase (approval and post-approval) drug studies for patients with type 2 diabetes. It includes specific recommendations for the design of prospective clinical studies that reflect the evidence expectations of payers, informed by the perspectives of patients, clinicians, and other decision makers. The recommendations are made in four major areas: population, outcomes, methods, and reporting for patient stakeholders.
Green Park Collaborative-USA Annual Progress Report 2013-2014
This report highlights the Green Park Collaborative-USA's year one accomplishments, as well as initiatives for the future.
Green Park Collaborative-USA Overview (2014)
This overview provides background on the purpose, structure, and expected outcomes of GPC-USA
Endocrine Metabolic Consortium Overview (Nov 2013)
As part of GPC-USA, the Endocrine-Metabolic Consortium will develop methodological standards for patient-centered outcomes research and comparative effectiveness research in endocrine and metabolic diseases.
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.
Establishing Work Priorities for GPC-USA (May 2013)
Penny Mohr, and Sean Tunis, MD, MSc gave this presentation at the Inaugural Green Park Collaborative meeting.
Green Park Collaborative - USA: Governance Establishment Discussion (May 2013)
Deloitte Consulting LLP, gave this presentation at the Inaugural meeting of the Green Park Collaborative.
An Overview of the Green Park Collaborative (May 2013)
Sean Tunis, MD, MSc, gave this presentation at the inaugural meeting of the Green Park Collaborative
Delivering Value in Healthcare: A Multi-Stakeholder Vision (May 2013)
The presentation was shared at the inaugural Green Park Collaborative meeting in May 2013
HTAi Policy Forum: Points of Relevance to GPC-USA (May 2013)
Chris Hensall gave this presentation at the Inaugural Green Park Collaborative meeting.
Green Park Collaborative Evaluation Report (April 2013)
An evaluation of the GPC's pilot project, which resulted in an EGD on the study of therapies for Alzheimer's disease.

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Green Park Collaborative resources

Designing Late Phase Clinical Trials of Disease-modifying Agents to Delay or Prevent Dementia due to Alzheimer 's Disease

coreHEM: Developing Comparative Effectiveness Outcomes for Gene Therapy in Hemophilia

A Multi-Pronged Strategy to Improve the Relevance, Usefulness, and Comparability of Outcomes in Clinical Research

CAP Accreditation Standards and Proficiency Testing for Diagnostic Next Generation Sequencing

Genomic Technologies Forum Meeting Briefing

RWE Decoder: A Practical Tool for Assessing Relevance and Rigor of Real World Evidence

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

Methods for Evaluating the Comparative Effectiveness of Interventions for Obesity and Overweight

Webinar: Initial Medical Policy and Model Coverage Guidelines

Next Gen Sequencing in Clinical Oncology: Phase 2 Overview

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

Highlights of the 2015 Annual GPC Meeting

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

Green Park Collaborative Annual Progress Report 2015

Demonstrating the Clinical Utility of Next Generation Sequencing in Clinical Oncology

Recommendations for Late Phase Drug Studies in Type 2 Diabetes (July 2014)

Green Park Collaborative-USA Annual Progress Report 2013-2014

Green Park Collaborative-USA Overview (2014)

Endocrine Metabolic Consortium Overview (Nov 2013)

Oncology Consortium Update

Oncology Overview (2013)

Establishing Work Priorities for GPC-USA (May 2013)

Green Park Collaborative - USA: Governance Establishment Discussion (May 2013)

An Overview of the Green Park Collaborative (May 2013)

Delivering Value in Healthcare: A Multi-Stakeholder Vision (May 2013)

HTAi Policy Forum: Points of Relevance to GPC-USA (May 2013)

Green Park Collaborative Evaluation Report (April 2013)