quirements are often strict and many patients have concerns about sharing personal information with researchers.

As described throughout this report, individuals with spinal cord injuries are presented with countless challenges in their everyday lives that make it difficult for them to travel. Depending on the severity of the injury and the resources available in their communities, an individual’s ability to travel independently may be further limited. Furthermore, for some individuals the travel necessary for participation in a clinical trial would be a significant expense. These challenges may limit the number of individuals available for a clinical trial, although there are opportunities to use existing regional patient care centers to facilitate access to clinical trials.

To increase the number of individuals with spinal cord injuries as potential clinical trial participants, health care professionals must be aware of ongoing clinical trials so that they can educate their patients about the available options and the benefits of participating in clinical trials. Efforts to increase the dissemination of information to both health care professionals and individuals with spinal cord injuries are needed.

Spontaneous Recovery Can Complicate Interpretation of Results

As discussed in Chapter 1, a small number of patients with incomplete injuries and paraplegia recover some function, particularly bowel and bladder function, usually within the first year after the injury (Maynard et al., 1979; Ditunno et al., 2000). Thus, the potential for the recovery of function that is not due to the intervention complicates the interpretation of clinical trial results and necessitates careful attention to the matching of a control group and the population receiving the intervention.

NEXT STEPS IN DESIGNING AND CONDUCTING CLINICAL TRIALS

Although investigators performing clinical trials of interventions for spinal cord injuries are presented with unique challenges, many tools and techniques can be used to maximize participation and improve data analysis.

Utilize Statistical Methodologies for Addressing Small Numbers of Patients and Heterogeneity of Outcomes

The limited number of individuals who qualify for clinical trials of interventions for spinal cord injuries and the heterogeneity of the nature and the severity of their injuries make it difficult to conduct multiple large-scale, randomized, controlled clinical trials. Furthermore, for studies that



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