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To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

To learn more about Triangle CERSI, join our mailing list for future communications.

Research

Research

Exploring and Understanding Regulatory Science

The Center leverages the breadth and depth of scientific expertise available across North Carolina's Research Triangle to conduct research, disseminate knowledge, catalyze action among stakeholders and advance regulatory decision making.

Request for Proposals

  • Innovative Technologies

    EXPIRED: Advancing pathogen reduction technologies for whole blood

    The Center for Biologics Evaluation and Research, Office of Blood Research and Review (OBRR) is inviting short proposals from CERSIs for potential regulatory research science projects to advance pathogen reduction technologies for whole blood.

  • Data Solutions

    EXPIRED: Real World Data Research in Hematologic Malignancies

    FDA Oncology Center of Excellence is interested in proposals that address: 1) Differentiation Syndrome for acute leukemia; 2) Efficacy of IDH inhibitors in different ethnic groups; 3) Real-world outcomes in patients with chronic myelomonocytic leukemia (CMML); and 4) Outcomes of patients with myelodysplastic syndrome in the real-world setting.

  • Data Solutions

    EXPIRED: Research to Improve the Health and Safety of Women

    The FDA Office of Women’s Health requests proposals addressing: 1) maternal morbidity and mortality with the goal of improving care and outcomes for diverse populations of women using real-world data or other innovative sources of data or 2) improving diagnostics, therapeutics and treatment utilization and identifying barriers for addressing chronic debilitating conditions in women.

  • Data Solutions

    EXPIRED: Using Real World Data to Supplement Clinical Trials to Explore Safety and Efficacy in Diverse Populations

    FDA Oncology Center of Excellence is interested in proposals exploring best practices and and novel methods for the design and analysis of studies based on real-world data for evaluating oncology medical products in diverse populations as part of a post-marketing requirement or post-marketing commitment.

Current Projects

  • Current Projects
    Statistical, AI & ML methodologies

    Triangle 001: Principal stratification methods and software for intercurrent events in clinical trials

    Intercurrent events that occur post randomization in randomized control trials (RCT), can alter the course of these trials and jeopardize comparative effectiveness evaluation and consequently decision making in regulatory science. The standard intention-to-treat analysis used for RCT does not account for intercurrent events, thus fails to capture treatment effect, heterogeneity, and causal mechanisms.

  • Current Projects
    Statistical, AI & ML methodologies

    Triangle 002: Utilizing the UNC Clinical Data Warehouse for Assessing Efficacy, Toxicity, and Dose-Response Relationships of Molecularly Targeted Therapies in Real-World Patients

    The FDA’s OCE launched 'Project Optimus' to emphasize the need for dosage optimization prior to drug approval. In collaboration with Project Optimus and the Oncology Real World Evidence program, this project harnesses the capabilities of statistical modeling, advanced data methods, and causal inference approaches using real-world data sourced from UNC-CH.

  • Current Projects
    Diversity, Equity and Inclusion in Clinical Trials

    Triangle 003: Enhancing the role of pharmacies in reducing opioid misuse and abuse in racial and ethnic minority and rural communities

    In the U.S., opioid overdose deaths have increased for those living in rural areas and among racial and ethnic minority communities. Access to support services for opioid misuse is lacking for these geographic regions and populations. This project aims to characterize the role community pharmacies play in decreasing harm from opioids by supporting safe use of opioid medications and access to medications for opioid use disorder treatment and overdose reversal.

  • Current Projects
    Drug Safety

    Triangle 004: Characterization of the impact of xylazine and dexmedetomidine: binding profile, addictive behaviors, physiology, and wound development

    The unregulated drug supply is an ever-changing chemical landscape with novel additives that are often unknown to end users, clinicians and public health officials. One such compound, xylazine, is now detected in the unregulated drug supply at alarming levels. This project uses pharmacological approaches to examine how xylazine and dexmedetomidine interact with receptors in the body, how they affect brain function, and influence fentanyl’s effects.

  • Current Projects
    Drug Safety

    Triangle 005: Developing a risk prediction engine for relapse in opioid use disorder

    Opioid Use Disorder (OUD) affects 2.7 million people in the U.S. and is responsible for 75% of opioid overdose deaths. Our project will generate a scientific plan to use digital health technologies (DHTs) and the data they collect to predict relapse and to inform early-intervention strategies for people living with OUD with the care they need, when they need it most.

  • Current Projects
    Clinical Areas of Focus

    Triangle 006: Recall of patient-reported symptoms and function in episodic disease/conditions, specifically temporomandibular disorders (TMDs)

    Patient-reported outcome (PRO) questionnaires ask patients about their symptoms and functions as input for medical device safety and effectiveness evaluation. The timeframe in these questionnaires needs to be long enough for completeness of recollections but also short enough for it to be easy to remember. This project aims to find the best ways to measure PRO for temporomandibular disorders, that present episodically or vary in frequency and intensity over time.

READDI for the next pandemic?

Watch UNC's Dr. Nat Moorman discuss READDI, a leading non-profit drug company dedicated to developing small molecule antiviral drugs aimed at combating the viruses responsible for global pandemics as part of the 2023 FDA CERSI Lecture Series.