Office of the Director
The Office of the Director provides scientific and administrative leadership for the Institute, including policy guidance, strategic program development and evaluation, and overall operational and administrative coordination.
- Meet the Director – Dr. Rodgers’ and Dr. Germino’s biographies, Dr. Rodgers’ vision statement, the NIDDK annual budget and report, and the Director’s Update newsletter
- Office of the Director staff and contact information
The Office of the Director also manages the following research support staff and programs.
Senior Advisors
NIDDK leadership invites input from senior advisors on high-priority, Institute-wide initiatives.
- Dr. Matthew Portnoy, research innovation and entrepreneurship
Office of Clinical Research Support
The NIDDK Office of Clinical Research Support is responsible for overseeing and coordinating the development of policies and procedures to guide extramural NIDDK-funded clinical studies and clinical trials, to ensure that such research is compliant with all NIH and HHS human subjects research policies, and that planning for and management of clinical research is consistent, effective and efficient across all divisions. The Office includes specialists in Biostatistics, Regulatory Affairs, Clinical Trial support, Data and Biospecimen Repositories, and Technology Transfer.
Access Office of Clinical Research Support staff and contact information.
Biostatistics Program
The mission of the NIDDK Biostatistics Program is to collaborate with NIDDK intramural and extramural staff to ensure appropriate standard and novel methodological approaches to advance scientific discovery. As methodological experts, we are proficient in the latest methodologies and techniques for the research design, statistical design, and statistical analysis methods for clinical and observational studies. Examples for leveraging our expertise include:
- Expert statistical review of new protocols including study design, definition of endpoints and planning for appropriate statistical methodologies
- Development of sample size estimates based on precision, statistical power, and/or other research design operating characteristics
- Expert feasibility and/or methodological protocol review prior to submission for scientific review or IRB approval (including outcome measures, definitions, and data collection plans)
- Expert collaboration to develop a statistical analysis plan, including plans that leverage innovations in clinical research design/analysis (adaptive design, causal inference, clinical prediction algorithms, longitudinal/multilevel data, machine learning)
- Expert review of data management and data sharing plans, to include aligning study data curation plans with emerging standards for data interoperability and regulatory oversight, where applicable
- Planning and conducting formal statistical analyses, following statistical analysis plan (SAP) and adapting implementations to mitigate peer critique per current best practices, e.g., stress-testing findings per SAP assumptions unverifiable from data
- Developing materials for scientific dissemination to include visualizations, scientific/technical writing, and formal responses for peer review
- Developing training session for statistical topics and methodologies which are novel or of interest
Access Biostatistics Program staff and contact information.
Regulatory Support Program
The NIDDK Regulatory Support Program provides regulatory support for all NIDDK-sponsored trials that require a U.S. or Canadian regulatory application for the use of an investigational drug or device in a clinical trial. Specifically, regulatory consultation is provided to aid in the determination of the need for a regulatory application, protocol development, study drug issues, and other regulatory matters. Regulatory support staff work with the program officials and data coordinating centers (or intramural investigator) to
- initiate regulatory applications,
- maintain applications (e.g., annual reports, protocol amendments),
- assist with safety reporting to FDA and Health Canada, and
- ensure that the Institute is in compliance with any existing or new regulatory requirements.
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NIDDK Central Repository
The NIDDK Central Repository makes data and biospecimens from current and previously funded NIDDK studies available to the broader scientific community. The Repository enables scientists not involved in the original study to test new hypotheses without having to collect new data or biospecimens, and it provides the opportunity to pool data across several studies to increase the power of statistical analyses. The NIDDK Central Repository has two contract-supported components, the Biorepository and the Data Repository, featuring:
- An archive of clinical qualitative and quantitative data and associated documentation from select NIDDK-funded studies and non-funded studies within NIDDK research mission areas
- A collection of biospecimens and an inventory database that identifies specimens collected from ongoing and completed studies funded by NIDDK and links them to the associated clinical data
- A web portal, Resources for Research (R4R), that contains study-specific information within the Repository and a catalogue of federated resources outside the Repository, and supports the submission and request for access to data and biospecimens
A collection of genotyping data from GWAS and sequencing studies housed at the National Center for Biotechnology Information's (NCBI) database of Genotypes and Phenotypes (dbGaP).
Access NIDDK Central Repository staff and contact information.