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Donna Niedzwiecki

Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
Duke Box 2717, Durham, NC 27710
2424 Erwin Rd, Hock Plaza, Suite 802, Rm 8040, Durham, NC 27705

Overview


Primary interests include clinical trials design and the design and analysis of biomarker and imaging studies especially in the areas of GI cancer, lymphoma, melanoma, transplant and cancer immunotherapy.

Current Appointments & Affiliations


Professor of Biostatistics & Bioinformatics · 2022 - Present Biostatistics & Bioinformatics, Division of Biostatistics, Biostatistics & Bioinformatics
Director, DCI Biostatistics · 2020 - Present Biostatistics & Bioinformatics, Basic Science Departments
Member of the Duke Cancer Institute · 1997 - Present Duke Cancer Institute, Institutes and Centers

Recent Publications


Safety and feasibility of talimogene laherparepvec in peritoneal surface malignancies: Results from the TEMPO trial

Journal Article Molecular Therapy Oncology · March 19, 2026 Peritoneal surface malignancies (PSMs) remain a therapeutic challenge, particularly in patients with unresectable disease who cannot benefit from cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. The Talimogene Laherparepvec for the Trea ... Full text Cite

Phase II trial of interleukin-12 followed by interferon alfa-2b in patients with metastatic malignant melanoma: Results from CALGB 500001 (Alliance).

Journal Article Cancer Immunol Res · January 8, 2026 The ability of interleukin-12 (IL-12) to stimulate production of interferon gamma (IFN-γ) suggested it might improve the efficacy of low dose interferon alpha (IFN-α). In this phase II trial, patients with metastatic malignant melanoma were administered re ... Full text Link to item Cite

Care Coordination for Patients Admitted With Alcohol-Associated Liver Disease: An Assessment of Appropriate Follow-up and Treatment at Time of Discharge.

Journal Article Gastro Hep Adv · 2026 BACKGROUND AND AIMS: The prevalence of alcohol-associated liver disease (ALD) is on the rise in the United States, and effective management requires multidisciplinary care and coordination of services across specialties. The aim of this study is to assess ... Full text Link to item Cite
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Recent Grants


Serum pro-N-cadherin as an early biomarker of radiation-induced heart disease

ResearchStatistician · Awarded by National Institutes of Health · 2025 - 2030

Project 2: Inflammation and Submucosal Glands During Esophageal Injury and Repair

ResearchCo Investigator · Awarded by Case Western Reserve University · 2023 - 2028

Biomarker validation for intraductal papillary mucinous neoplasms of the pancreas

ResearchCo Investigator · Awarded by National Cancer Institute · 2018 - 2028

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Education, Training & Certifications


Yale University · 1984 Ph.D.