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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 Mol Ther Oncol · 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 Link to item 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 · March 4, 2026 The ability of IL12 to stimulate production of IFNγ suggested it might improve the efficacy of low-dose IFNα. In this phase II trial, patients with metastatic malignant melanoma were administered recombinant human (rh) IL12 followed by IFNα2b. Primary endp ... Full text Link to item Cite

Toxicity of Ablative Radiation Therapy in the Management of Patients with Child-Pugh B/C Liver Function and Unresectable Hepatocellular Carcinoma (HCC).

Journal Article Cancers (Basel) · February 19, 2026 BACKGROUND/OBJECTIVES: Hypofractionated ablative radiation is an increasingly popular option for patients with hepatocellular carcinoma (HCC). However, concern remains about the risk for radiation-induced liver toxicity in patients with decompensated liver ... 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


Yale University · 1984 Ph.D.