People

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

Multicenter Clinical Cancer Research After COVID-19: A Perspective From NRG Oncology.
Gensheimer MF, Yom SS, Soto N, Dignam JJ, Le QT, Machtay M, Curran WJ. Multicenter Clinical Cancer Research After COVID-19: A Perspective From NRG Oncology. Int J Radiat Oncol Biol Phys. 2020 10 01; 108(2):483-485.
PMID: 32890539

Disparities in Breast Cancer: Narrowing the Gap.
Dignam JJ. Disparities in Breast Cancer: Narrowing the Gap. J Natl Cancer Inst. 2020 Sep 28.
PMID: 32986842

Do reminder emails and past due notifications improve patient completion and institutional data submission for patient-reported outcome measures?
Pugh SL, Rodgers JP, Moughan J, Bonanni R, Boparai J, Chen RC, Dignam JJ, Bruner DW. Do reminder emails and past due notifications improve patient completion and institutional data submission for patient-reported outcome measures? Qual Life Res. 2020 Sep 07.
PMID: 32894431

Characteristics of Participation in Patient-Reported Outcomes and Electronic Data Capture Components of NRG Oncology Clinical Trials.
Pugh SL, Rodgers JP, Yeager KA, Chen RC, Movsas B, Bonanni R, Dignam J, Bruner DW. Characteristics of Participation in Patient-Reported Outcomes and Electronic Data Capture Components of NRG Oncology Clinical Trials. Int J Radiat Oncol Biol Phys. 2020 Nov 15; 108(4):950-959.
PMID: 32590048

Event-Free Survival, a Prostate-Specific Antigen-Based Composite End Point, Is Not a Surrogate for Overall Survival in Men With Localized Prostate Cancer Treated With Radiation.
Xie W, Regan MM, Buyse M, Halabi S, Kantoff PW, Sartor O, Soule H, Berry D, Clarke N, Collette L, D'Amico A, Lourenco RA, Dignam J, Eisenberger M, James N, Fizazi K, Gillessen S, Loriot Y, Mottet N, Parulekar W, Sandler H, Spratt DE, Sydes MR, Tombal B, Williams S, Sweeney CJ. Event-Free Survival, a Prostate-Specific Antigen-Based Composite End Point, Is Not a Surrogate for Overall Survival in Men With Localized Prostate Cancer Treated With Radiation. J Clin Oncol. 2020 Sep 10; 38(26):3032-3041.
PMID: 32552276

Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer.
Dess RT, Sun Y, Jackson WC, Jairath NK, Kishan AU, Wallington DG, Mahal BA, Stish BJ, Zumsteg ZS, Den RB, Hall WA, Gharzai LA, Jaworski EM, Reichert ZR, Morgan TM, Mehra R, Schaeffer EM, Sartor O, Nguyen PL, Lee WR, Rosenthal SA, Michalski JM, Schipper MJ, Dignam JJ, Pisansky TM, Zietman AL, Sandler HM, Efstathiou JA, Feng FY, Shipley WU, Spratt DE. Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer. JAMA Oncol. 2020 05 01; 6(5):735-743.
PMID: 32215583

Biomarker-Driven Oncology Clinical Trials: Key Design Elements, Types, Features, and Practical Considerations.
Hu C, Dignam JJ. Biomarker-Driven Oncology Clinical Trials: Key Design Elements, Types, Features, and Practical Considerations. JCO Precis Oncol. 2019; 3.
PMID: 32923854

Association of Black Race With Prostate Cancer-Specific and Other-Cause Mortality.
Dess RT, Hartman HE, Mahal BA, Soni PD, Jackson WC, Cooperberg MR, Amling CL, Aronson WJ, Kane CJ, Terris MK, Zumsteg ZS, Butler S, Osborne JR, Morgan TM, Mehra R, Salami SS, Kishan AU, Wang C, Schaeffer EM, Roach M, Pisansky TM, Shipley WU, Freedland SJ, Sandler HM, Halabi S, Feng FY, Dignam JJ, Nguyen PL, Schipper MJ, Spratt DE. Association of Black Race With Prostate Cancer-Specific and Other-Cause Mortality. JAMA Oncol. 2019 07 01; 5(7):975-983.
PMID: 31120534

Quality of Life in Patients With Low-Risk Prostate Cancer Treated With Hypofractionated vs Conventional Radiotherapy: A Phase 3 Randomized Clinical Trial.
Bruner DW, Pugh SL, Lee WR, Hall WA, Dignam JJ, Low D, Swanson GP, Shah AB, Malone S, Michalski JM, Dayes IS, Seaward SA, Nguyen PL, Pisansky TM, Chen Y, Sandler HM, Movsas B. Quality of Life in Patients With Low-Risk Prostate Cancer Treated With Hypofractionated vs Conventional Radiotherapy: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2019 May 01; 5(5):664-670.
PMID: 30763425

A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses.
Xie W, Halabi S, Tierney JF, Sydes MR, Collette L, Dignam JJ, Buyse M, Sweeney CJ, Regan MM. A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses. JNCI Cancer Spectr. 2019 Mar; 3(1):pkz002.
PMID: 31360890

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Elected Fellow
Society for Clinical Trials
2019

Inducted Member
Delta Omega, National Public Health Honor Society
1991