Human Studies Consultation
Core

Co-Director
Til Stürmer, MD, PhD sturmer@unc.edu

Co-Director
Anna Kahkoska, MD, PhD anna_kahkoska@med.unc.edu

Navigator
TBD

Request Core Service

New Opportunity to Connect in 2026:

Join us the second Wednesday of each month from 5:00 - 6:00 PM and bring your research related questions! In-person and virtual attendance options.

In-Person: Carolina Square, Room 4002, 133 W Franklin St, Chapel Hill, NC

Virtual: Zoom Link (Password: rxdiabetes)

An innovative consultative service to facilitate partnerships between preclinical and clinical investigators, promote rigorous human subjects research, and generate clinically relevant evidence for people with diabetes

 

The HSCC aims to help NCDRC members:
1) adapt preclinical and translational discoveries into practice; and 2) expand their diabetes research portfolios in the clinical and epidemiologic realm, leveraging training and expertise between basic scientists, population health scientists, methodologists, and clinicians across the NCDRC.

The core is intended to serve all members, irrespective of their current stage in study ideation or planning. Consultations may encompass preliminary study concepts as well as more advanced considerations such as study design, data sources, defining suitable target populations, statistical methodology, regulatory compliance, and developing rigorous, inclusive research protocols.

For basic scientists, this core can support the extension of new research findings into a tangible clinical implementation.

For clinicians, clinician scientists, and other diabetes researchers (health services, epidemiology), this core can provide guidance on inclusion of technical topics such as the integration of continuous glucose monitoring data into research, big data and real-world evidence approaches using claims data, recruiting underrepresented research subjects, and advanced methods and study design.

With sufficient lead time and a well-defined research question, this core can assist diabetes researchers by extracting key metrics for grant proposals from large healthcare data sources, such as Medicare claims or MarketScan data, including counts of patients who meet specific study eligibility criteria.

National initiatives in which we are involved, including
- NIH Collaboratory,
- Clinical Trials Transformation Initiative,
- National Patient-Centered Clinical Research Network (PCORnet), and its Diabetes & Obesity Collaborative Research Group.

We invite all members (trainees, staff, and faculty) to join, regardless of where you are in study ideation and planning, and we welcome the discussion of new study concepts alongside more specific questions regarding study design, data sources, statistical methods, and regulatory considerations.

To schedule an individual consultation, please use the “Request Core Service” button. The Core should be contacted in the early stages of any research project and can help with all aspects of human subject’s research, including:

  • Developing and refining scientific objectives and specific aims

  • Grant writing and grantsmanship

  • Study design considerations

  • Data collection and/or selection of data sources

  • Selection of key outcomes

  • Extraction of key metrics for grant proposals from large healthcare data source (pending sufficient lead time and analyst availability)

  • Understanding and navigating requisite regulatory and administrative approvals

  • Advanced pharmacoepidemiology methods, including causal inference and target trial emulation

Consultative

Services

Request Core Service

Example Questions for the Core:

  • What study designs are appropriate for addressing my research question?

  • Do my specific aims have a logical and testable hypothesis?

  • Can you help me define a target population within in Medicare claims data for my research question?

  • How should I define the target population to match my study aims? How can inclusion/exclusion criteria be optimized to ensure both internal validity and generalizability?

  • Can you help me estimate basic numbers or metrics I need for a grant proposal—for example, the number of patients using a specific diabetes medication—from Medicare fee-for-service claims and MarketScan claims data?

  • What approvals (IRB, data use agreements, HIPAA considerations) will I need for this project?

  • What strategies of recruitment would be most effective for reaching my target population? Are my proposed research aims feasible from a recruitment and retention perspective?

  • What strategies can I use to address confounding, selection bias, or immortal time bias in a study that analyzes existing healthcare data at my institution?

  • How can target trial emulation or other causal inference methods improve the rigor and interpretability of my study?

  • Should I consider surrogate, composite, or patient-centered outcomes?

  • What are the logistics of integrating CGM data into my study design?

  • What budget considerations are critical for studies requiring specialized data or analytic methods?