Human Studies Consultation
Core

Director
Morgana Mongraw-Chaffin, PhD, MPH mmongraw@wakehealth.edu

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

Navigator
Morgana Mongraw-Chaffin, PhD, MPH mmongraw@wakehealth.edu

An innovative approach focusing on consultative services to facilitate partnerships between preclinical and clinical investigators.

 

This core is a unique way to adapt preclinical and translational discoveries into practice. This core aims to merge training and expertise between basic scientists and clinicians for applying new science, defining appropriate target populations, and designing incisive research protocols. The core’s consultative services will support the extension of new research findings into a tangible clinical implementation. This will provide a potentially powerful approach to relieving the translational bottleneck.

Consultants will use their expertise and knowledge of available resources, especially those included in our Clinical and Translational Science Award sites, to provide guidance on inclusion of continuous glucose monitors in, big data and real world evidence approaches using claims, recruiting underrepresented research subjects, and advanced methods and study design to promote clinical translation for NCDRC investigators.

The consultative services will take advantage of other national initiatives in which we are involved, including the NIH Collaboratory, the Clinical Trials Transformation Initiative, the National Patient-Centered Clinical Research Network (PCORnet), and its Diabetes & Obesity Collaborative Research Group.

Consultative

Services

The NCDRC Human Studies Consultation Core resources include:

  • Inclusion of continuous glucose monitors into research including feasibility, appropriate device selection, statistical analysis of highly repeated data and measurable outcomes, integration with data from other devices, and logistics for remote data collection.

  •  Assistance with strategies for using claims data including Medicare and MarketScan.

  • Clinical studies methods including pharmacoepidemiology, comparative effectiveness research, and real world evidence.

  • Advanced study design and methods to reduce bias and threats to validity including addressing confounding, selection bias, information bias, immortal person time, and the use of propensity scores.

  • Effectively and appropriately accessing underrepresented populations in diabetes research.