Spinal Cord Injury Trust, to develop a set of outcome measures for spinal cord injury.
Investigator bias, either deliberate or unintended, can also significantly affect the interpretation of the results and analysis of the outcomes of clinical trials. Although independent peer review is designed to address these concerns, not every study, especially early-phase trials, enters peer review. Furthermore, reviewers are rarely given access to patients so that the reviewers can conduct their own evaluations, and the reviewers do not usually have access to the raw data from the study. Because of potential conflicts, it is important that evaluation of the findings from the trial be performed by unbiased coinvestigators or others researchers who were not part of the study. In response to concerns regarding patient safety, the policy of the National Institutes of Health requires that multisite clinical trials of interventions that may involve a risk to the participant establish a data safety monitoring board that is independent of IRBs and that is responsible for ensuring that the clinical trial is conducted with the highest regard for patient safety and ethical standards and to ensure the credibility of the clinical trial and the validity of the study results.
The level of investment in research and development on interventions for spinal cord injuries by the pharmaceutical and medical device industries is difficult to determine. A number of clinical trials of medications have focused on improving bowel, bladder, and sexual function (see Appendix G); and the Pharmaceutical Research and Manufacturers of America’s New Medications in Development database indicates that a number of medications for alleviating neuropathic pain are in phase I and phase II clinical trials (PhRMA, 2004a).
The potential financial incentives for industry to invest in the research and development of interventions to treat spinal cord injuries may be limited for a number of reasons, including the following:
Further research is needed on the basic mechanisms of neuronal injury and repair to target therapeutic approaches.
Only recently have the science and experimental methodology reached the stage at which the screening of large numbers of candidate drugs and compounds is possible.
Spinal cord injury is not a single outcome; rather, the types of