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Spinal Cord Injury: Progress, Promise, and Priorities (2005)

Chapter: Appendix A Study Process

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Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
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A
STUDY PROCESS

The committee reviewed and considered a broad array of information in its work on issues involving spinal cord injury research. Information sources included the primary scientific literature; books and scientific reviews; and presentations from researchers, representatives from federal agencies and nonprofit organizations, and individuals with spinal cord injuries.

LITERATURE REVIEW

Extensive bibliographic searches were conducted and resulted in a reference database of more than 2,000 entries. Searches of the primary biomedical bibliographic databases, Medline and EMBASE,1 were supplemented with searches of Dissertation Abstracts, Lexis-Nexis, and THOMAS (a federal legislative database). The Dissertation Abstracts database provided information on the current level of Ph.D. thesis production in the field of neurological diseases.2 Additionally, a specific Medline search for clinical trials of therapeutic interventions for spinal cord injuries performed from 1998 to 2003 was conducted (see Appendix G).

1  

Excerpta Medica.

2  

IOM staff searched the Dissertation Abstracts database using the search terms “spinal cord injur?,” “multiple sclerosis,” “brain AND (ischemia OR stroke),” “Parkinson? (within two spaces) disease,” and “Alzheimer? (within three spaces) disease.” The question mark is used to search for terms with multiple endings. For example, the search term “spinal cord injur?” resulted in hits that included “spinal cord injury” and “spinal cord injuries.”

Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
×

To identify information on funding mechanisms and trends from the National Institutes of Health (NIH), Institute of Medicine (IOM) staff queried the Computer Retrieval of Information on Scientific Projects (CRISP) database. This database collects information on the number of federally funded biomedical research projects. Data from the CRISP database were used to assess the number of fellowships (F grants), career grants (K grants), research grants (e.g., R01 grants), project grants (P grants), and Small Business Innovation Research and Small Business Technology Transfer awards funded by NIH. To discern the number of NIH grants directed toward various neurological disorders, IOM staff used appropriate keywords (which appeared in a 9,000-word thesaurus) for various neurological conditions. Projects that addressed more than one neurological condition were counted separately for each condition. Additional information on general funding trends at NIH was located in published documents and was provided by NIH staff.

PUBLIC WORKSHOPS

The committee held four meetings over the course of the study to address the study charge, review the data collected, and develop the report. Three of those meetings included public workshops: February 23-24, 2004; May 24-25, 2004; and September 27-28, 2004.

The first workshop (Box A-1) included three sessions that covered basic and clinical research needs, clinical trials in industry, and translational research.

The committee held the second public workshop (Box A-2) on May 24-25, 2004, in Washington, D.C. In that workshop the committee heard from 13 speakers who had expertise in emerging therapies for spinal cord injuries, stem and olfactory ensheathing cells, neuropathic pain, robotics and physical therapy, clinical research methods, and federal program management.

The third meeting took place on September 27-28, 2004, in Washington, D.C. The public workshop (Box A-3) consisted of three sessions that included a review of state-sponsored spinal cord injury research programs, a discussion of how the Food and Drug Administration (FDA) deals with the complexities associated with spinal cord injuries, and a community perspectives session in which nonprofit organizations and individuals with spinal cord injuries provided input on future research priorities.

Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
×

BOX A-1
Institute of Medicine Committee on Spinal Cord Injury Workshop Tuesday, February 24, 2004

8:30

Welcome to the Workshop

Richard T. Johnson, Johns Hopkins University

Session I: Basic and Clinical Research Needs

8:40

What Do Basic Scientists Most Need to Apply Their Knowledge About Neural Injury and Repair to Clinical Use?

Moses V. Chao, New York University

9:00

What Do Clinicians Need Most to Improve Treatment of Spinal Cord Injuries?

John A. Jane, University of Virginia

Session II: Clinical Trials in Industry

9:35

Challenges of Developing New Treatments from the Context of Current Industry Models

Dennis W. Choi, Merck & Company, Inc.

9:55

Challenges of Conducting Clinical Trials on Spinal Cord Injury in Industry

Andrew R. Blight, Acorda Therapeutics, Inc.

Session III: Translational Research

10:45

The Reeve-Irvine Research Center for Spinal Cord Injury

Oswald Steward, University of California, Irvine

11:05

Translational and Clinical Research in a Related Disorder (Amyotrophic Lateral Sclerosis)

Jeffrey D. Rothstein, Johns Hopkins University

11:40

General Discussion

Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
×

BOX A-2
Institute of Medicine Committee on Spinal Cord Injury Workshop

May 24, 2004

8:25

Welcome and Introductions

Richard T. Johnson, Johns Hopkins University

Session I: Emerging Therapies and Evaluation of Their Potential

8:30

Cell Death and Plasticity: Identifying Therapeutic Targets for the Treatment of Spinal Cord Injuries

Alan Faden, Georgetown University

8:55

Oxidative Stress and Cell Death: An Overview of Stroke Research and Lessons for Spinal Cord Injuries

Pak Chan, Stanford University

9:20

Developing Animal Models for Spinal Cord Injuries

Michael Beattie, Ohio State University

Session II: Stem and Olfactory Ensheathing Cells

10:20

Potentials and Pitfalls of Stem Cell Therapies: Lessons Learned from the Treatment of Cancer

Irving Weissman, Stanford University

10:45

Is There a Role for Stem Cell Treatments for Patients with Spinal Cord Injuries?

Evan Snyder, Burnham Institute, San Diego

11:10

Olfactory Ensheathing Cell Transplants as a Treatment for Spinal Cord Injuries

Geoff Raisman, National Institute for Medical Research, London, United Kingdom

Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
×

Session III: Neuropathic Pain

1:00

Potential Therapies to Treat Pain Syndromes in Spinal Cord Injuries

Claire Hulsebosch, University of Texas Medical Branch

Session IV: Robotics and Physical Therapy

1:35

Developing Neural Prostheses

William Heetderks, National Institute of Biomedical Imaging and Bioengineering

2:00

Physical Therapies and Electrical Stimulation as Treatments for Spinal Cord Injuries

V. Reggie Edgerton, University of California, Los Angeles

Session V: Clinical Research Methods

2:55

Statistical Methods and Patient Registries as Tools for Clinical Spinal Cord Injury Research

Ralph Frankowski, University of Texas at Houston

3:20

Registries as Clinical Research Tools: A Case Study of the Bone Marrow Transplant Registries

Fausto Loberiza, Jr., Medical College of Wisconsin

3:45

Alternatives to Large-Scale, Randomized Controlled Trials

Curtis Meinert, Johns Hopkins University

Session VI: Discussion of Overarching Themes

4:30

General Discussion

5:00

Adjourn

Tuesday, May 25, 2004

10:45

NIH Programs That Facilitate Clinical Research on Spinal Cord Injuries

Naomi Kleitman, Program Director, Repair and Plasticity, National Institute of Neurological Disorders and Stroke

Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
×

BOX A-3
Institute of Medicine Committee on Spinal Cord Injury Workshop

September 27, 2004

9:30

Welcome and Introductions

Richard T. Johnson, Johns Hopkins University

 

Review of State-Sponsored Spinal Cord Injury Research Programs

Mary Bunge, Miami Project to Cure Paralysis

Marie Filbin, Hunter College of the City University of New York

Rajiv Ratan, Burke/Cornell Medical Research Institute

Christopher Shields, Kentucky Spinal Cord Injury Research Center

10:00

Discussion: How Can State-Run Programs Maximize Their Impact?

11:00

Spinal Cord Injury Therapeutics—Regulatory Challenges

Cynthia Rask, Director, Division of Clinical Evaluation and Pharmacology/Toxicology, Food and Drug Administration

11:20

Discussion: How to Overcome the Challenges in Getting Drug Therapies and Devices Approved by the FDA?

September 28, 2004

Community Perspectives

11:00

Welcome and Introductions

Richard T. Johnson, Johns Hopkins University

 

Community Perspectives Session

John Bollinger, Paralyzed Veterans of America

Paul J. Tobin, United Spinal Association

Z. Alexander Gentle, an individual with arachnoiditis

11:30

Discussion of Community Needs and Priorities

2:30

Community Perspectives (continued)

Congressman James Langevin,

2nd Congressional District, Rhode Island

Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
×
Page 243
Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
×
Page 244
Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
×
Page 245
Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
×
Page 246
Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
×
Page 247
Suggested Citation:"Appendix A Study Process." Institute of Medicine. 2005. Spinal Cord Injury: Progress, Promise, and Priorities. Washington, DC: The National Academies Press. doi: 10.17226/11253.
×
Page 248
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An estimated 11,000 spinal cord injuries occur each year in the United States and more than 200,000 Americans suffer from maladies associated with spinal cord injury. This includes paralysis, bowel and bladder dysfunction, sexual dysfunction, respiratory impairment, temperature regulation problems, and chronic pain. During the last two decades, longstanding beliefs about the inability of the adult central nervous system to heal itself have been eroded by the flood of new information from research in the neurosciences and related fields. However, there are still no cures and the challenge of restoring function in the wake of spinal cord injuries remains extremely complex.

Spinal Cord Injury examines the future directions for research with the goal to accelerate the development of cures for spinal cord injuries. While many of the recommendations are framed within the context of the specific needs articulated by the New York Spinal Cord Injury Research Board, the Institute of Medicine’s panel of experts looked very broadly at research priorities relating to future directions for the field in general and make recommendations to strengthen and coordinate the existing infrastructure. Funders at federal and state agencies, academic organizations, pharmaceutical and device companies, and non-profit organizations will all find this book to be an essential resource as they examine their opportunities.

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