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.”



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Spinal Cord Injury: Progress, Promise, and Priorities 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.”

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Spinal Cord Injury: Progress, Promise, and Priorities 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.

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Spinal Cord Injury: Progress, Promise, and Priorities 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

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Spinal Cord Injury: Progress, Promise, and Priorities 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

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Spinal Cord Injury: Progress, Promise, and Priorities 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

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Spinal Cord Injury: Progress, Promise, and Priorities 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