James J. Dignam, PhD

Dr. Dignam's primary research involves the design, conduct, and analysis of cancer clinical trials, including early development (phase I), pilot efficacy and safety (phase II), and definitive evaluation (phase III) trials. He is the Executive Director of the Statistics and Data Management Center for NRG Oncology, a National Cancer Institute sponsored multi-center clinical trials group with over 500 recruitment sites in North America and beyond and over 100 active clinical trials. Dr. Dignam's methodology interests include trial monitoring and early stopping rules, competing risks, hazard function estimation, and prognostic modeling. He also has engaged in and led investigations into sociodemographic factors such as race/ethnicity and BMI/obesity on cancer prognosis and treatment response. Courses taught include introductory biostatistics, clinical trials, survival analysis, and regression modeling methods.

University of Pittsburgh, Graduate School of Public Health
Pittsburgh
PhD - Biostatistics
1994

Saint Xavier College
Chicago
BA - Mathematics
1986

Lumpectomy Margins and Local Recurrence in DCIS: Results From the NRG Oncology/NSABP B-35 Randomized Clinical Trial.
Lumpectomy Margins and Local Recurrence in DCIS: Results From the NRG Oncology/NSABP B-35 Randomized Clinical Trial. JAMA Surg. 2026 09 01; 161(9):861-869.
PMID: 42384406

Influence of Adverse Pathologic Features on Potential Benefit of Hormone Therapy Use with Postoperative Radiotherapy in Recurrent Prostate Cancer: An Individual Patient Data Meta-analysis.
Influence of Adverse Pathologic Features on Potential Benefit of Hormone Therapy Use with Postoperative Radiotherapy in Recurrent Prostate Cancer: An Individual Patient Data Meta-analysis. Eur Urol. 2026 Jul 28.
PMID: 42521517

Hormone therapy use and duration with postoperative radiotherapy for recurrent prostate cancer: an individual patient data meta-analysis.
Hormone therapy use and duration with postoperative radiotherapy for recurrent prostate cancer: an individual patient data meta-analysis. Lancet. 2026 03 14; 407(10533):1059-1071.
PMID: 41765025

Docetaxel with Androgen Deprivation and Radiotherapy in High-risk Localized Prostate Cancer: An ICECaP Individual Patient Data Meta-analysis.
Docetaxel with Androgen Deprivation and Radiotherapy in High-risk Localized Prostate Cancer: An ICECaP Individual Patient Data Meta-analysis. Eur Urol Oncol. 2025 Dec 17.
PMID: 41412841

Dual Immune Check Point Blockade in MGMT-Unmethylated Newly Diagnosed Glioblastoma: NRG Oncology BN007, a Randomized Phase II/III Clinical Trial.
Dual Immune Check Point Blockade in MGMT-Unmethylated Newly Diagnosed Glioblastoma: NRG Oncology BN007, a Randomized Phase II/III Clinical Trial. J Clin Oncol. 2025 09 20; 43(27):3032-3040.
PMID: 40779733

Validation of a Longitudinal Marker as a Surrogate Using Mediation Analysis and Joint Modeling: Evolution of the PSA as a Surrogate of the Disease-Free Survival.
Validation of a Longitudinal Marker as a Surrogate Using Mediation Analysis and Joint Modeling: Evolution of the PSA as a Surrogate of the Disease-Free Survival. Biom J. 2025 08; 67(4):e70064.
PMID: 40579808

Phase 3 Trial of Dose-Escalated Radiation Therapy and Standard Androgen Deprivation Therapy Versus Dose-Escalated Radiation Therapy and Enhanced Androgen Deprivation Therapy With Orteronel for Men With High-Risk Prostate Cancer (NRG/RTOG 1115).
Phase 3 Trial of Dose-Escalated Radiation Therapy and Standard Androgen Deprivation Therapy Versus Dose-Escalated Radiation Therapy and Enhanced Androgen Deprivation Therapy With Orteronel for Men With High-Risk Prostate Cancer (NRG/RTOG 1115). Int J Radiat Oncol Biol Phys. 2025 12 01; 123(5):1247-1258.
PMID: 40712984

Duration of Androgen Suppression with Postoperative Radiotherapy (DADSPORT) for Nonmetastatic Prostate Cancer: A Collaborative Systematic Review and Meta-analysis of Aggregate Data.
Duration of Androgen Suppression with Postoperative Radiotherapy (DADSPORT) for Nonmetastatic Prostate Cancer: A Collaborative Systematic Review and Meta-analysis of Aggregate Data. Eur Urol. 2025 Sep; 88(3):277-290.
PMID: 40571441

On the use of external controls in clinical trials.
On the use of external controls in clinical trials. J Natl Cancer Inst Monogr. 2025 03 01; 2025(68):30-34.
PMID: 39989040

Design and analysis considerations for investigating patient subgroups of interest within cancer clinical trials.
Design and analysis considerations for investigating patient subgroups of interest within cancer clinical trials. J Natl Cancer Inst Monogr. 2025 03 01; 2025(68):22-29.
PMID: 39989043

View All Publications

Co-recipient, Statistical Partnership Among Academe, Industry, and Government (SPAIG) Award
American Statistical Association
2021

Elected Fellow
Society for Clinical Trials
2019

Inducted Member
Delta Omega, National Public Health Honor Society
1991