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).
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.
BOX A-1
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BOX A-2
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BOX A-3
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