NIAID Clinical Trials

NIAID supports both infrastructure and clinical trial networks through a variety of targeted funding opportunities. NIAID's clinical research infrastructure includes coordinating centers, statistical units, data centers, central laboratories, clinical centers, Data and Safety Monitoring Boards (DSMBs), drug procurement and pharmacy support, regulatory support, site monitoring and other specialized resources. Clinical trial networks have defined structure and components, as well as specific submission deadlines.  Applicants should review the relevant NOFO requirements as application deadlines, clinical trial network application requirements, and availability of infrastructure support can vary amongst funding opportunities.

In addition to these targeted opportunities, NIAID is also interested in supporting investigator-initiated clinical trials. NIAID does not fund investigator-initiated research that is duplicative of work funded through clinical research infrastructure and network funding opportunities. Early consultation with NIAID scientific contacts can provide guidance in preparing applications that are appropriate to the intended program. This process also aids applicants to delineate the detailed plans, processes, and documentation needed to conduct a clinical trial. If the trial requires an investigational device exemption (IDE) or investigational new drug (IND), NIAID reserves the right to specify the entity (NIAID, primary recipient, etc.) who will hold the IND/IDE. Principal investigators (PIs) can discuss options with the appropriate NIAID program staff. Applicants may refer to the Research Methods Resources website for information about developing statistical methods and study designs for their clinical trials.

NIAID accepts applications for all phases, a range of intervention types, and multiple trial methods within its mission areas. Innovative trial designs and methods, as well as novel intervention modalities, are encouraged.

• Phases — early- through later-phase large-scale efficacy and implementation studies, supporting the full path from proof of concept, initial safety and dose-finding testing to real-world delivery.
• Intervention types — therapeutics (small molecules, antibodies, antimicrobials, gene and cellular therapies, microbiome-based therapies, and other novel modalities), vaccines and immune-based prevention approaches, adjuvants, diagnostics (including point-of-care and biomarker-based tools), non-pharmaceutical and behavioral interventions including environmental or dietary.
• Trial methods — prevention, treatment, and diagnostic trials; superiority, non-inferiority, or estimation trials; parallel-group or crossover trials; platform studies; adaptive designs; enrichment designs including enrollment based on endotypes or relevant biomarkers; natural history and epidemiological studies tracking disease progression, transmission, or risk factors; and implementation science studies evaluating how evidence-based interventions are delivered, scaled, or adopted in real-world settings.

The decision to support a given trial depends on several factors including technical merit, relative program priority, budget sufficiency, and available funds. For allergy, transplantation, and immune-mediated diseases, additional consideration will be given to clinical trials that include hypothesis driven research using biologic samples from trial participants aimed at understanding the mechanisms of these conditions or the mode of action of the treatment(s) under investigation. Applicants should review the relevant NOFO for phase, design, and documentation requirements specific to their study.