Clinical Trials Overview
A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. The NIDCD is committed to building and expanding its clinical trials program to promote the development of interventions to treat or prevent communication and other disorders in the areas of hearing, balance, taste, smell, voice, speech, and language. The NIDCD has a longstanding history of funding research in the basic sciences in all of these areas and encourages the transition from basic science discoveries to clinical trials and other patient-oriented research.
The NIDCD recognizes that the body of work necessary to fully develop an intervention—especially a new intervention—is an extensive, long-term endeavor. Support is needed at every step, from basic science discovery to early stage translational research, culminating in clinical trials to establish safety and efficacy of the intervention, as well as late stage translational research to optimize proven interventions or the development of treatment guidelines for widespread clinical practice.
Clinical research supported by the NIDCD must meet high standards of scientific rigor in both how the study is designed and how it is carried out and maintained. The safety of volunteer participants is the highest priority.
Both the NIDCD Phase I/II/III Clinical Trials in Communication Disorders and NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders use a U cooperative agreement mechanism. This mechanism enables the NIDCD program official to have substantial scientific and programmatic involvement, combined with routine stewardship, both before application submission and after award (see Terms and Conditions for Cooperative Agreements).