Biomedical Clinical Trials of DOC Conditions Program
Overview
The Biomedical Clinical Trials of Dental, Oral, and Craniofacial (DOC) Conditions Program supports well-designed and well-executed clinical trials (Phase I, II, III, and IV) that test interventions and have the potential to improve DOC health. These trials should provide scientific evidence that can be used for establishing or changing the standard of care, or for consideration of a change in health care policy. To be eligible for NIH funding, all clinical research involving investigational drugs, biologics, devices, or other products regulated by the Food and Drug Administration (FDA) must comply with all applicable FDA requirements. Examples of supported research include:
- Clinical trials testing the safety, efficacy, or effectiveness of new preventive or treatment therapies for dental, oral, or craniofacial diseases (e.g., dental caries, periodontal diseases, head and neck cancer, orofacial pain conditions, salivary gland dysfunction)
- Conducting comparative safety and effectiveness studies of dental, oral, or craniofacial disease treatments
- Clinical trials testing the ability of diagnostic criteria, reliable markers, oral biosensors/biodevices, and/or imaging techniques to diagnose and assess the onset and progression of dental, oral, or craniofacial diseases
- Clinical trials testing the safety, efficacy, or effectiveness of tissue regeneration therapies to repair or replace dental, oral or craniofacial tissues
- Clinical trials testing the safety, efficacy, or effectiveness of therapies to prevent or treat dental, oral, or craniofacial sequelae of systemic treatments in individuals with chronic or medically complex conditions
Practice-based research describes clinical research conducted in a clinical care setting with consenting patients. Essentially, it is research done in the “real world” of daily clinical practice. Practice-based research can generate important and timely information to guide the delivery of health care and improve patient outcomes and has the following features:
- Collecting data from clinicians about factors contributing to decision-making and procedures performed, and separately, collecting data from a patient's perspective
- Enrolling patients from a variety of practice settings and types, with each clinician contributing a relatively small number of patients
- Potentially accelerating the dissemination and implementation of evidence-based treatments for use by dental clinicians to prevent and manage dental, oral, and craniofacial diseases
NIDCR supports practice-based research through the National Dental Practice-Based Research Network (PBRN), a nationally coordinated program committed to advancing knowledge of dental practice and ways to improve it, and the Practice-Based Research Integrating Multidisciplinary Experiences in Dental Schools (PRIMED) initiative, which supports opportunities to conduct practice-based research in dental school clinics and/or affiliated clinics to foster development of clinical and patient-oriented research skills in an educational setting.
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