NHLBI Working Group

Clinical Research Networks for the 21st Century

Executive Summary

Purpose

This Working Group was convened on May 9-10, 2007 by the NHLBI Division of Lung Diseases to recommend the optimal configuration of clinical research networks that will both incorporate key goals of the 2007 NHLBI Strategic Plan and address pressing clinical research questions in lung diseases over the next 5-10 years.

Background

Division of Lung Diseases (DLD) clinical research networks

  • Asthma Clinical Research Network (ACRN) (established 1993)
  • Acute Respiratory Distress Syndrome Network (ARDSNET) (established 1994)
  • Childhood Asthma Research and Education (CARE) Network (established 1999)
  • COPD Clinical Research Network (CCRN) (established 2003)
  • Interstitial Pulmonary Fibrosis Network (IPFnet) (established 2005)

have been highly successful, and the objective of this Working Group was to assure that DLD clinical research networks continue to provide scientific leadership and are poised to address the 2007 NHLBI Strategic Plan, which emphasizes the need to identify and implement clinical research structures that maximize new technologies, collaborations, and scientific opportunities and cultivate an environment for trainees at all levels to develop skills in clinical research.

Agenda

Several weeks before the meeting, participants were asked to provide the most important clinical research questions for the next 5 - 10 years within their lung disease specialties and opinions about what they valued most about networks and what improvements they would most like to see. Participants were also asked to consider whether clinical research networks should address questions other than specific clinical management questions; for example, should networks incorporate broader aspects of the research continuum from disease mechanism, diagnostic and treatment discoveries, to community practice-based collaborations? A synthesis of responses was distributed to participants a week before the meeting and this guided whole group discussions prior to separation into three breakout groups. Breakout groups were asked to develop a model(s) for future network(s) to address important lung, critical care and sleep research questions over next the 5-10 years. Although everything was open for discussion, each group was asked to consider:

  • Which lung diseases are suitable for study in clinical networks?
  • Can studies of several lung diseases be coordinated in a single clinical research structure? If so, how?
  • If there are multiple networks, should there be a means for them to collaborate? What would be important elements / issues to share?
  • How could networks collaborate with other entities?
  • How could the structure of network(s) promote greater efficiencies and productivity in designing and conducting clinical research?
  • How could the structure of network(s) promote training opportunities?

The first day concluded with a summary presentation of each model to the entire Working Group. The rationale for models was presented and discussed the following morning. The meeting concluded with discussion of essential features of a clinical research network and development of recommendations for how clinical research networks (CRNs) for the 21st Century should be organized. The following is a synopsis of the recommendations.

  1. Maintain focus on improving clinical care, but allow flexibility to expand research scope to permit:
    1. Valuable and opportune proof of concept and mechanistic studies directly related to a parent trial, such as biomarkers of disease progression or treatment response, and pressing Phase II trials.
    2. Sub-studies: Establish annual budgets for sub-studies with implications for patient care, including correlative science (e.g., association of biomarkers with treatment phenotypes / exacerbation phenotypes), health economics (e.g., cost-effectiveness analyses) and patient-centric outcomes (e.g., quality of life, activities of daily living). These would be reviewed by the PRC and/or DSMB.
    3. Observational trials that address prevention, natural history, and impact of co-morbidities.
    4. Inclusion and characterization of healthy controls when scientifically justified.
  2. Facilitate and promote scientific exchange across CRNs and other clinical research programs.
    1. Develop mechanisms to (1) facilitate transfer of findings relevant to CRN research agenda from other programs (e.g. SCCOR, PPGs, R01s) to CRNs and (2) promote use of the phenotype/genotype/biological sample data by basic science investigators outside the network.
    2. Create a scientific advisory committee of basic scientists, clinical scientists and community-based practitioners across lung, critical care and sleep disorders to inform the research agenda, to provide broad-based scientific and clinical advice, to help identify the most clinically important and scientifically informative clinical trials without scientific overlap, to promote exchange on cross-cutting themes, and to provide an assessment of direction and overall contribution of the CRNs and other clinical programs to public health.
    3. Develop lines of communication between CRNs to share approaches to disease evaluation related to biomarkers, genetics, imaging, pulmonary physiology, et cetera, and to examine if there are common pathways.
  3. Structure CRNs to maximize programmatic and scientific efficiency.
    1. Sustain disease orientation of CRNs, but enhance coordination and cooperation among networks, including, for example, integrating certain CRNs or allowing cross network participation in protocols.
    2. Facilitate the use of satellites (clinical sites with infrastructure to execute protocols).
    3. Provide longer funding cycles to account for start-up times and costs.
    4. Coordinate with Clinical and Translational Science Award grant sites (CTSAs).
    5. Increase public visibility of CRNs to enhance involvement of patients and community-based clinicians with the goal of (1) increasing awareness of the benefits and opportunities afforded by participating in clinical research and (2) expanding enrollment in CRN clinical trials.
    6. Partner with large healthcare plans, community groups, consumer media and community-based physicians to encourage patient participation in trials.
    7. Create tailored programs and community partnerships to engage economically disadvantaged and/or minority populations.
    8. Establish better approaches for partnering with industry and for obtaining drugs and placebos.
  4. Promote shared resources and common practices / standardization.
    1. Develop mechanisms to share and, where appropriate, consolidate, special resources across networks. For example, consider a "Virtual DCC" that will serve as a "Concierge" for specialized services to all DLD networks, such as genetic statistics, cost-effective analyses, consultation for clinical trial design, facilitating interactions with other government agencies and Pharma.
    2. Develop standard procedures for collection, storage (including consideration of a centralized repository), and distribution of biologic samples to maximize utility for a range of analyses.
    3. Encourage standardized methods and measures (e.g., MOP templates, data collection forms, case report forms).
    4. Promote a uniform data curation process across networks (e.g., use of common data elements, vocabulary, case definitions, phenotypes).
  5. Promote Training.
    1. Conduct an inter-CRNs meeting to develop more efficient programs for training.
    2. Promote and create incentives for team science and collaborative clinical trial participation.
    3. Leverage CRNs for clinical skills development of medical students, residents, fellows and junior faculty.
    4. Promote training and resources for mentors.
    5. Leverage CTSAs to provide training experiences and opportunities for collaboration.

Working Group Members


Chair

  • Reynold A. Panettieri, Jr., M.D., University of Pennsylvania, Philadelphia , PA

Breakout Group Chairs

  • Jeffrey M. Drazen, M.D., New England Journal of Medicine, Boston, MA
  • Lynn M. Taussig M.D., University of Denver, Denver, CO
  • Steven Piantadosi, M.D., Ph.D., Johns Hopkins University, Baltimore, MD

Members

  • Roberta A. Ballard, M.D., University of California, San Francisco, CA
  • Robyn J. Barst, M.D., Columbia University, New York, NY
  • Gordon R. Bernard, M.D., Vanderbilt University School of Medicine, Nashville, TN
  • Badrul A. Chowdhury, M.D., Ph.D. , US Food and Drug Administration, Silver Spring, MD
  • Karen A. Fagan, M.D., University of Colorado Health Sciences Center, Denver, CO
  • Lawrence Friedman, M.D., Rockville, MD
  • Gary W. Hunninghake, M.D. , University of Iowa, Iowa City, IA
  • Joel N. Kline, M.D., University of Iowa, Iowa City, IA
  • Clete A. Kushida, M.D., Ph.D., Stanford University, Stanford, CA
  • Stephen C. Lazarus, M.D., University of California, San Francisco, CA
  • Robert F. Lemanske, Jr., M.D., University of Wisconsin Hospital & Clinics, Madison, WI
  • Carole L. Marcus, M.B.B.Ch., The Children's Hospital of Philadelphia, Philadelphia, PA
  • Fernando J. Martinez, M.D., M.S., University of Michigan Health System, Ann Arbor, MI
  • Michael A. Matthay, M.D., University of California, San Francisco, CA
  • Bruce McManus, M.D., Ph.D., FRSC, FCAHS, St. Paul Hospital, Vancouver, BC
  • Shirley Murphy, M.D., US Food and Drug Administration, Silver Spring, MD
  • Dennis E. Niewoehner, M.D., VA Medical Center, Minneapolis, MN
  • Stephen P. Peters, M.D., Ph.D., Wake Forest University School of Medicine, Winston-Salem, NC
  • Bonnie Ramsey, M.D., University of Washington, Seattle, WA
  • Stanley J. Szefler, M.D., National Jewish Medical and Research Center, Denver, CO
  • Scott T. Weiss, M.D., M.S., Brigham and Women's Hospital, Boston, MA
  • Christine H. Wendt, M.D., University of Minnesota, Minneapolis, MN
  • Sally E. Wenzel, M.D., University of Pittsburgh, Pittsburgh, PA
  • O'Dale Williams, Ph.D., University of Alabama, Birmingham, AL

NHLBI Staff

  • Susan B. Shurin, M.D., Office of the Director, Bethesda, MD
  • James P. Kiley, Ph.D., Division of Lung Diseases, Bethesda, MD
  • Dorothy Gail, Ph.D., Division of Lung Diseases, Bethesda, MD
  • Michael Twery, Ph.D., Division of Lung Diseases, Bethesda, MD
  • Gail G. Weinmann, M.D., Division of Lung Diseases, Bethesda, MD
  • Tom Croxton, Ph.D., M.D., Division of Lung Diseases, Bethesda, MD
  • Weiniu Gan , Ph.D., Division of Lung Diseases, Bethesda, MD
  • Andrea Harabin, Ph.D., Division of Lung Diseases, Bethesda, MD
  • Patricia Noel, Ph.D., Division of Lung Diseases, Bethesda, MD
  • Hannah Peavy, M.D., Division of Lung Diseases, Bethesda, MD
  • Tony Punturieri, M.D., Ph.D., Division of Lung Diseases, Bethesda, MD
  • Herbert Reynolds, M.D., Division of Lung Diseases, Bethesda, MD
  • Susan Schlegel, Ph.D., Division of Lung Diseases, Bethesda, MD
  • Barry Schmetter, B.S., Division of Lung Diseases, Bethesda, MD
  • Robert A. Smith, Ph.D., Division of Lung Diseases, Bethesda, MD
  • Virginia Taggart, M.P.H , Division of Lung Diseases, Bethesda, MD



July 2007




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