What are Clinical Trials?

To accelerate the translation of experimental therapies into "standards of care", Miami Project investigators conduct clinical trials. Clinical trials are organized studies conducted with people as research volunteers. The studies are designed to answer specific questions about new therapies or about new ways to use standard therapies. When new treatments are designed, researchers must demonstrate to colleagues and clinicians how the new treatment compares to standard treatment. Once clear results are obtained, researchers communicate their findings to medical and rehabilitation professionals through research reports and publications. 

A "protocol" is a set of rules for how the experiment will be conducted. Researchers design the protocol so that it will clearly answer a research question in a way that can be generalized to apply to other persons with SCI. Each clinical trial has a protocol that specifies the length of the study, the schedule of tests or interventions, how the results are to be measured, and inclusion criteria that define the type of people included in the study. Examples of inclusion criteria are type of injury, time since injury, age, gender, etc. For further information about how clinical trials are carried out, see www.clinicaltrials.gov