Regulatory Support Services

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications, trials & patents

Abstract

The Office of Clinical Research Policy and Regulatory Operations (OCRPRO) supported the conduct of 171 active clinical trials in FY25 from 17 NIAID laboratories and other clinical research projects by providing an array of services to ensure that FDA and other DHHS regulations were fulfilled including; (1) appropriate management of investigational new drug sponsor responsibilities; (2) data and safety board management; (3) clinical safety reporting, and; (4) clinical trial monitoring for study compliance. Additionally, OCRPRO manages over 96 Investigational New Drugs Application, Investigational Devices exemptions, and Drug Master Files at various stages of development for studies conducted at the NIH Clinical Center, at academic medical centers throughout the US, and in 4 countries. These activities constitute a collective safety system to protect research participants and enhance the integrity of study conduct for NIAID sponsored research. OCRPRO staff continued to provide a comprehensive protocol development program to assist intramural clinical researchers in the launching of new studies. While many of these activities took place within the context of the traditional NIAID intramural program conducted at the NIH Clinical Center, several of the actions assisted in the accomplishment of larger NIAID actions conducted through NIAID ICERs (International Centers for Excellence in Research), and disease-specific networks, and programmatic networks such as the Partnership for Research on Ebola VACcination (PREVAC) and Partnership for Research on Vaccines and Infectious Diseases in Liberia (PREVAIL). Within these programs , OCRPRO supported four multicenter projects under the Cambodia ICER program, focusing on immune response characterization to various zoonotic viruses, including Zika, dengue, and chikungunya. Additionally, OCRPRO staff remained involved in supporting an extension of follow-up for the multi-sponsor/multi-partner PREVAC and PREVAIL studies, which focused on Ebola, COVID and retroviral infections in Mali and Liberia. In addition, OCPRO supported a measles virus infection study investigating the effect on pre-existing immunity in Guinea and Mali. Further, the PALM partnership in the Democratic Republic of Congo (DRC) was another project involving OCRPRO staff with the continuation of a monkeypox therapeutic study at two sites in DRC during this time period. All OCRPRO activities were conducted with a focus on coordination of activities by the respective regulatory functions in an effort to promote the timely and effective operation of the research enterprise to include the intramural research programs in HIV, biological defense, and emerging infectious diseases. OCRPRO acts as IND sponsor for COVID studies operationalized by the STRIVE network which is an international network of sites able to respond rapidly to emerging infectious disease (EID) outbreaks. OCRPRO continues to provide extended supports for the safety oversight and regulatory aspects, working closely with regulatory authorities to ensure timely report.