Core outcome set for gene therapy in haemophilia: Results of the coreHEM multistakeholder project

Iorio A, Skinner MW, Clearfield E, Messner D, Pierce GF, Witkop M, Tunis S; for the coreHEM panel. Core outcome set for gene therapy in haemophilia: Results of the coreHEM multistakeholder project. Haemophilia. 2018;00:1–6. https://doi.org/10.1111/hae.13504

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.

Insurance Coverage for Genomic Tests

Phillips KA, Trosman JR, Deverka PA, Quinn B, Tunis S, Neumann PJ, Chambers JD, Garrison LP Jr, Douglas MP, Weldon CB. Insurance coverage for genomic tests. Science 2018 April 20. 360(6386):278-279. doi: 10.1126/science.aas9268. Epub 2018 Apr 19. PMID: 29674586

Paying for Cures: Perspectives on Solutions to the “Affordability Issue”

Karlsberg Schaffer S, Messner D, Mestre-Ferrandiz J, Tambor E, Towse A. Paying for Cures: Perspectives on Solutions to the ‘Affordability Issue.’ Value in Health 2018; 21: 276-279.

Choosing Important Health Outcomes for Comparative Effectiveness Research: An updated systematic review and involvement of low and middle income countries.

Davis K, Gorst SL, Harman N, Smith V, Gargon E, Altman DG, Blazeby JM, Clarke M, Tunis S, Williamson PR. Choosing important health outcomes for comparative effectiveness research: an updated systematic review and involvement of low and middle-income countries. PONE-D-17-33253R1. PLoS One. 2018 Feb 13;13(2):e0190695. doi: 10.1371/journal.pone.0190695. eCollection 2018. PMID: 29438429 PMCID: PMC5810981 DOI: 10.1371/journal.pone.0190695

Stakeholder Perspectives Regarding Alternate Approaches to Informed Consent for CER

Morain S, Tambor E, Moloney R, Kass N, Tunis S, Hallez K, Faden R. Stakeholder perspectives regarding alternative approaches to informed consent for comparative effectiveness research. Learn Health Sys 2017;e10047. doi: 10.1002/lrh2.10047

Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-Stakeholder Consensus

Conley RB, …, Al Naber J, Messner, DA, et al. Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-Stakeholder Consensus. Cell 2017;171(5):982-986. doi.org/10.1016/j.cell.2017.10.032

Core Outcome Set-STAndards for Development: The COS-STAD recommendations

Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, Williamson PR. Core Outcome Set-STAndards for Development: The COS-STAD recommendations. PLoS Med 2017;14(11):e1002447. doi: 10.1371/journal.pmed.1002447. eCollection. PMID: 29145404

Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains.

Lipman PD, Loudon K, Moloney R, Messner D, Stoney CM. Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains. Trials 2017;18(1):532. doi. 10.1186/s13063-017-2267-y. PMID: 29126437

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.

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).

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.

Payer perspective on future acceptability of comparative effectiveness and relative effectiveness research (2015)

Moloney R, Mohr P, Hawe E, Shah K, Garau M, Towse A. Payer perspective on future acceptability of comparative effectiveness and relative effectiveness research. Int. J. Technol. Assess. Health Care. 2015;31(1-2):90-98. doi:10.1017/S0266462315000203. PMID: 26168804

Medical and pharmacy coverage decision making at the population level (2014)

Mohr PE, Tunis SR. Medical and pharmacy coverage decision making at the population level. J. Manag Care Pharm. 2014;20(6):547-554. PMID: 24856592

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.

Understanding the role and evidence expectations of health technology assessment and coverage/payer bodies: What are they looking for, and how and why does this differ from what regulators require? (2014)

Henshall C, Sanson L, Eichler H-G, Lemgruber A, Longson C, O’Rourke B, Tunis S. Understanding the role and evidence expectations of health technology assessment and coverage/payer bodies: What are they looking for, and how and why does this differ from what regulators require? Therapeutic Innovation & Regulatory Science. 2014;48(3):341-46. doi:10.1177/2168479013512488.

The views of quality improvement professionals and comparative effectiveness researchers on ethics, IRBs, and oversight (2015)

Whicher D, Kass N, Saghai Y, Faden R, Tunis S, Pronovost P. The views of quality improvement professionals and comparative effectiveness researchers on ethics, IRBs, and oversight. J Empir Res Hum Res Ethics. 2015;10(2):132-44. doi:10.1177/1556264615571558

Green Park Collaborative Annual Progress Report 2015

This report shows the Green Park Collaborative's 2015 accomplishments, as well as upcoming initiatives.

Futurescapes: Evidence expectations in Europe for comparative effectiveness research for drugs in 2020 (2015)

Towse A, Garau M, Mohr P, Messner DA. Futurescapes: Evidence expectations in Europe for comparative effectiveness research for drugs in 2020. J Comp Eff Res. 2015;4(4):401-18. doi:10.2217/CER.15.7. PMID: 25740283. ISSN: 2042-6305.

Futurescapes: Evidence expectations in the USA for comparative effectiveness research for drugs in 2020 (2015)

Messner DA, Mohr PE, Towse A. Futurescapes: Evidence expectations in the USA for comparative effectiveness research for drugs in 2020. J Comp Eff Res. 2015;4(4):385-400. doi:10.2217/CER.15.6. PMID: 25730709. ISSN: 2042-6305.

The future of comparative effectiveness and relative efficacy of drugs: an international perspective (2015)

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.

From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients (2015)

Eichler H-G, Baird LG, Barker R, … Tunis SR, et al. From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients. Clin Pharmacol Ther. 2015;97(3):234-46. doi:10.1002/cpt.59. PMID: 25669457

Reimbursing NGS Testing. Clinical OMICs – Molecular diagnostics in personalized medicine (2015)

Tunis S. Reimbursing NGS Testing. Clinical OMICs – Molecular diagnostics in personalized medicine. online digital publication (http://www.nxtbook.com/nxtbooks/gen/clinical_omics_vol2iss1/#/20). 2015;2(1):21-23.

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.

What can comparative effectiveness research contribute to integrative health in international perspective? (2014)

Witt C, Withers SR, Grant S, Lauer M, Tunis SR, Berman B. What can comparative effectiveness research contribute to integrative health in international perspective? J Altern Complement Med. 2014;20(11):874-80. doi: 10.1089/acm.2014.0073. PMID: 25372702. PMCID: PMC4238246

A Multi-stakeholder Agenda to Advance Enhanced Recovery for U.S. Surgical Patients

This white paper builds upon earlier work, including a multi-stakeholder forum in which participants discussed potential challenges and opportunities to accelerate the adoption of Enhanced Recovery Protocols (ERPs) in the U.S. The white paper shares key insights from the forum regarding potential steps to overcome barriers, and proposes a roadmap to accelerate the adoption of ERPs in the U.S.

Summary & Slides: Hepatitis C Drugs - Evidence to Demonstrate Effectiveness and Value

On July 7, 2014, the Green Park Collaborative (GPC) of the Center for Medical Technology Policy (CMTP) and the Institute for Clinical and Economic Review (ICER) co-hosted a web conference to explore the evidence needed to demonstrate the effectiveness and value of new drugs to treat chronic hepatitis C (HCV) infection.

exCERpts July 2014

This is the July 2014 CMTP newsletter

Enhanced Recovery Meeting Summary

June 10, 2014, with initial support from Edwards Life Sciences, CMTP hosted a multi-stakeholder forum to discuss accelerated adoption of enhanced recovery protocols (ERP) for high risk surgical patients.

Accelerated access to innovative medicines for patients in need (2014)

Baird LG, Banken R, Eichler H-G, Kristensen FB, Lee DK, Lim JCW, Lim R, Longson C, Pezalla E, Salmonson T, Samaha D, Tunis S, Woodcock J, Hirsch G. Accelerated access to innovative medicines for patients in need. Clin Pharmacol Ther. 2014;96(5):559-71. doi: 10.1038/clpt.2014.145. PMID: 25006877

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.

EGD Process Document (June 2014)

Information is provided on the general process for developing EGDs, and the resulting products developed from each step. Appendix items include a process flowchart and a template EGD. outline.

exCERpts May 2014

This is the May 2014 CMTP newsletter.

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.

The Current Drug Development Paradigm: Responding to US and European Demands for Evidence of Comparative Effectiveness and Relative Effectiveness

Pharmaceutical companies face rapidly evolving regulatory and reimbursement evidentiary expectations linked to the clinical and economic realities confronting the healthcare system. Health care spending pressures, a lack of information to guide the efficient use of new technologies, and consequent political momentum are promoting the need for an enhanced generation of evidence to inform post-regulatory clinical and coverage decision-making. This white paper serves to ascertain how the current drug development paradigm at five global pharmaceutical companies is evolving in response to perceived demands for evidence of comparative effectiveness and relative effectiveness, in particular, from payers and HTA bodies, but also from clinicians and patients.

Debating the Evidence of Pharmacogenetic Testing

Pat Deverka, MD, MS participated in a 6 member debate entitled “DEBATING ABOUT THE EVIDENCE FOR CLINICAL UTILITY OF PHARMACOGENETIC TESTING” at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2014 Annual Meeting in Atlanta, GA.

exCERpts February 2014

This is the Feburary 2014 CMTP newsletter.

Green Park Collaborative-USA Overview (2014)

This overview provides background on the purpose, structure, and expected outcomes of GPC-USA

Stakeholder Defined Research: Designing Studies that reflect the perspectives of patients, clinicians and payers (February 2014)

This is a presentation given by Pat Deverka as part of EPG Grand Rounds, at the University of Maryland

Payer Perspectives on Improving Usability of Effective Health Care Products (February 2014)

Bridging the Gap Between Information Needs and Evidence Translation. This report, produced for AHRQ's Effective Health Care (EHC) Program, provides payer perspectives on how to improve the usability of reports produced by the EHC program.

PCORnet PPRN Partner Meeting (January 2014)

A workshop hosted by PCORI for its Patient-Powered Research Network (PPRN) partners. The goal of the workshop was to provide PPRN partners with a forum to share resources, address concerns, and foster the creation of a high-performing, patient-powered collaborative.

PCORnet Kickoff Meeting (January 2014)

On January 21 and 22, 2014, the Engelberg Center for Healthcare Reform at the Brookings Institution hosted the kickoff meeting, "PCORnet: Building Evidence through Innovation and Collaboration.” This event launched the development of a clinical research network aimed at delivering high quality care through patient-centered outcomes research. This was the first opportunity for PCORnet Partners to meet and begin exchanging ideas, strategies and best practices for scaling up effectiveness research focusing on interventional trials and observational studies.

Early Pharmaceutical Pragmatic Clinical Trials (December 2013)

A white paper on the historical context for a discussion about pragmatic clinical trials and their place in drug approval.

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.

COMET Initiative: Core outcome measures in effectiveness trials (Nov 2013)

This presentation was part of the GPC-USA 2013 Annual Meeting

This is the first session of the GPC-USA 2013 Annual Meeting.

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.

Progress Update: Endocrine-Metabolic Consortium

Update on GPC-USA Endocrine-Metabolic Consortium provided at November 2013 Annual Meeting by Nisa Maruthur, Johns Hopkins University School of Medicine.

GPC-USA Annual Meeting Presentations (Nov 2013)

This presentation by Sean Tunis provides an update on the first six months of GPC-USA.

Electronic Consent: A Discussion of the eConsent Experience, Ethical and Regulatory Considerations, and the IRB Review Process

Donna Messner participated in this presentation at the 2013 Advancing Ethical Conference. Her co-presenters were J. Andy Bertolatus and J. Claire Carbary.

Oncology Overview (2013)

Part of GPC-USA, the Oncology Consortium will develop methodological standards for research research in oncology.

exCERpts November 2013

This is the November 2013 CMTP newsletter.

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes? (Oct 2013)

Calonge N, Klein RD, Berg JS, et al. Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes? Genet Med. 2013; doi: 10.1038/gim.2013.141. PMID: 24071797.

Bariatric Surgery CED

In February of 2013, CMTP hosted a stakeholder meeting of private payers, Maryland Medicaid representatives, a labor union, and self-insured employers. Participants discussed challenges and opportunities for Coverage with Evidence Development (CED) in connection with three cases: bariatric surgery, a diagnostic test, and interventions for autism.

Methodological recommendations for comparative research on the treatment of chronic wounds.

Sonnad SS, Goldsack JC, Mohr P, Tunis S. J Wound Care. 2013 Sep;22(9):470-80. PMID: 24005781

Medicare Policy on Bariatric Surgery: Decision Making in the Face of Uncertainty (Sept 2013)

Tunis SR, Messner DA. Medicare policy on bariatric surgery: decision making in the face of uncertainty. J Amer Med Assoc. 2013: doi:10.1001/jama.2013.278849

Recommendations for the Design of Phase 3 Pharmaceutical Trials that are more Informative for Patients, Clinicians, and Payers (Sept 2013)

Sonnad SS, Mullins CD, Whicher D, Goldsak J, Mohr PE, Tunis SR. Contem Clin Trials. 2013:pii:S1157-7144(13):132-138

Ethics and Informed Consent for Comparative Effectiveness Research with Prospective Electronic Clinical Data (August 2013)

Faden RR, Kass, NE, Whicher DM, Stewart W, Tunis SR. Med Care. 2013;51(8 Suppl 3):S53-7. doi: 10.1097/MLR.0b013e31829b1e4b. PMID: 23793051

Break a Vicious Cycle (July 2013)

Hayes DF, Allen J, Compton C, Gustavsen G, Leonard DGB, McCormack R, Newcomer L, Pothier K, Ransohoff D, Schilsky RL, Sigal E, Taube SE, Tunis SR. Sci Transl Med. 2013:5(196):196cm6. doi:10.1126scitranslmed.3005950

NIH Collaboratory Stakeholder Engagement Core (July 2013)

Sean Tunis presented at NIH Collaboratory Grand Rounds on the first meeting of the SAG

Encouraging Value-based Insurance Designs in State Health Insurance Exchanges (July 2013)

Buttorff CA, Tunis SR, Weiner JP. Am J Manag Care. 2013;19(7):593-600. PMID: 23919422

Performance-based Risk-sharing Arrangements—Good Practices for Design, Implementation, and Evaluation: Report of the ISPOR Good Practices for Performance-based Risk-sharing Arrangements Task Force. (July 2013)

Garrison LP, Towse A, Briggs A, de Pouvourville G, Grueger J, Mohr PE, Severens JL, Siviero P, Sleeper M. Value in Health. 2013;16(5):703-719. doi:10.1016/j.jval.2013.04.011

exCERpts July 2013

This is the July 2013 CMTP newsletter.

EGD Overview (2014)

This document provides background on the purpose of EGDs, a framework for creating them, insights on scope and topic selection, and the development process.

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.

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

Pat Deverka, MD, MS, MBE, gave this presentation at the inaugural meeting of the Green Park Collaborative.

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.

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.

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.

Value-of-Information Analysis Within a Stakeholder-driven Research Prioritization Process in a US Setting: An Application in Cancer Genomics (April 2013)

Carlson JJ, ..., Esmail LC, Deverka PA, et al. Med Decis Making. 2013;33(4):463-471. doi: 10.1177/0272989X13484388. PMID: 23635833

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.

exCERpts April 2013

This is the April CMTP newsletter.

Design of Clinical Studies of Pharmacologic Therapies for Alzheimer’s Disease (April 2013)

This EGD on Alzheimer's disease tests a process for developing disease-specific guidance for clinical studies that meet the needs of both payers and health technology assessment bodies.

Regulatory and Reimbursement Innovation (March 2013)

Lindor RA, Allocco SJ, Cheatham L, et al. Sci. Transl. Med. 2013;5(176):176cm3. doi: 10.1126/scitranslmed.3005437

Recommendations From the EGAPP Working Group: Does Genomic Profiling to Assess Type 2 Diabetes Risk Improve Health Outcomes? (March 2014)

Evaluation of Genomic Applications in Practice Prevention Working Group. Genet Med. 2013:15(8):612-617. doi:10.1038/gim.2013.9

Recommendations from the EGAPP Working Group: Can Testing of Tumor Tissue for Mutations in EGFR Pathway Downstream Effector Genes in Patients with Metastatic Colorectal Cancer Improve Health Outcomes by Guiding Decisions Regarding anti-EGFR Therapy? (Feb 2013)

Calonge N, Fisher NL, Berg AO, et al. Genet Med. 2013; doi: 10.1038/gim.2012.184. PMID: 23429431.

Getting Our Priorities Straight: a Novel Framework for Stakeholder-informed Prioritization of Cancer Genomics Research (Feb 2013)

Esmail LC, Roth J, Deverka PA. Genet Med. 2013;15(2):115-122. doi: 10.1039/gim.2012.103. PMID: 23037935

Improving the efficiency and relevance of evidence-based recommendations in the era of whole-genome sequencing: an EGAPP methods update (January 2013)

Veenstra DL, Piper M, Tunis SR et al. Genet Med. 2013;15(1):14-24. doi: 10.1038/gim.2012.106. PMID: 22955111

An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics (January 2013)

Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis SR, Beauchamp TL. Hastings Center Report. 2013:43(s1):S16-S27. doi: 10.1002/hast.134

The Research-treatment Distinction: A Problematic Approach for Determining Which Activities Should have Ethical Oversight (January 2013)

Kass NE, Faden RR, Goodman SN, Pronovost P, Tunis SR, Beauchamp TL. Hastings Center Report. 2013;43(s1):S4-S15. doi: 10.1002/hast.133

Stakeholder Participation in Comparative Effectiveness Research: Defining a Framework for Effective Engagement (December 2012)

Deverka PA, Lavallee DM, Desai PJ, Esmail LC, Ramsey SD, Veenstra DL, Tunis SR. J Comp Eff Res. 2012;1(2):181–194. PMID: 22707880. PMCID: PMC3371639

Incorporating Stakeholder Perspectives in Developing a Translation Table Framework for Comparative Effectiveness Research (December 2012)

Gliklich RE, Tunis SR, Mohr PE, Messner DA, Moloney RM, Karkare SU, et al. J Comp Eff Res. 2012; 1(3), 281-292. doi: 10.2217/cer.12.25.

Stakeholder Assessment of the Evidence for Cancer Genomic Tests: Insights from Three Case Studies (December 2012)

Deverka PA, Schully SD, Ishibe N, et al. Genet Med. 2012;14(7):656-662. doi: 10.1038/gim.2012.3. PMID:22481130

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

Basch E, … Spencer MR, Tunis SR, et al. J Clin Oncol. 2012;30(34);4249-4255. doi: 10.1200/JCO.2012.42.5967. PMID:23071244

Improving the Efficiency and Effectiveness of Pragmatic Clinical Trials in Older Adults in the United States.

Saag KG, Mohr PE, Esmail L, Wright N, Curtis JR, Cutter G, Delzell E, Gary LC, Lewis CE, Harrington TM, Karkare SU, Kilgore ML, Moloney R, Mudano AS, Oliveira A, Singh J, Warriner A, Zhang J, Berger M, Cummings SR, Pace W, Solomon DH, Wallace R, Tunis SR. Improving the efficiency and effectiveness of pragmatic clinical trials in older adults in the United States. Contemp Clin Trials. 2012;33(6)1211-1216. doi: 10.1016/j.cct.2012.07.002. PMID: 22796098

Methodological Recommendations for Comparative Effectiveness Research on the Treatment of Chronic Wounds (October 2012)

This EGD provides specific recommendations to product developers and clinical researchers on the design of comparative effectiveness studies for the treatment of chronic wounds, specifically those pertaining to arterial and venous disease-related ulcers, diabetic foot ulcers, pressure ulcers, and burn wounds

Effectiveness Guidance Document (EGD) for Acupuncture Research - a Consensus Document for Conducting Trials (Sept 2012)

Witt CM, Aickin M, Tunis SR, et al. BMC Complement Altern Med. 2012;12(1):148. doi 10.1189/1472-6882-12-148. PMID: 22953730

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.