Photo of Steven Piantadosi,  MD, PhD

Steven Piantadosi, MD, PhD

Brigham And Women's Hospital

Brigham And Women's Hospital
Phone: (617) 732-8727

Steven Piantadosi, MD, PhD

Brigham And Women's Hospital


  • Professor in Residence, Surgery, Harvard Medical School
  • Associate Senior Biostatistician, Surgical Oncology, Brigham And Women's Hospital


Research Abstract

I am an experienced clinical trial methodologist and scientist with 37 years in research and health care leadership. Innovative clinical trials are my special interest. My career has touched a very large number of clinical trials of all types, including multi-center and international trials, academic portfolios, and regulatory issues. Although much of my work has been in cancer, I have participated regularly in clinical trials in other disciplines such as neurodegenerative diseases, and cardiovascular disease. The constant theme is trial methodology.

From 2008-2017, I was Director of the Samuel Oschin Cancer Institute at Cedars Sinai Medical Center, a UCLA teaching hospital, and the largest hospital in the western U.S. The Cancer Center sees about 5500 new cases each year with a pluralistic faculty that is a mix of full time appointees, hospital-owned delivery network physicians, and private practitioners.

My personal research focus has always been in clinical trials methods. I have had a focus on translational and early developmental trials. In addition to collaborative work, I am a co-investigator on an NCI R01addressing designs for dose-finding with two or more agents simultaneously. I taught Clinical Trials in the Specialty Training and Research (STaR) program at UCLA for 7 years, and my textbook on clinical trials is recently published in its 3rd edition. It has become a standard in the field. I have also taught extensively in national workshops focused on training of clinical investigators in both cancer and neurologic disease, and I am a Fellow of the Society for Clinical Trials.

Prior to 2007, I was a division head in the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center where I founded and built the Biostatistics and Bioinformatics programs. I was Professor of Oncology in the School of Medicine as well as Professor of Biostatistics, and Epidemiology in the Hopkins School of Public Health. In 20 years at Hopkins I was funded on collaborative and original peer-reviewed research from dozens of NIH grants. There I also taught Clinical Trials in the Graduate Training Program in Clinical Research, mentored many clinical research fellows, and supervised doctoral research in biostatistics and epidemiology. I am a founding member of the New Approaches to Brian Tumor Therapy Consortium (now Adult Brain Tumor Group) which has had nearly 25 years of NCI funding.

Publications from Harvard Catalyst Profiles

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  • Singh K, Batich KA, Wen PY, Tan AC, Bagley SJ, Lim M, Platten M, Colman H, Ashley DM, Chang SM, Rahman R, Galanis E, Mansouri A, Puduvalli VK, Reardon DA, Sahebjam S, Sampson JH, Simes J, Berry DA, Zadeh G, Cloughesy TF, Mehta MP, Piantadosi S, Weller M, Heimberger AB, Khasraw M. Designing Clinical Trials for Combination Immunotherapy: A Framework for Glioblastoma. Clin Cancer Res 2021. PubMed
  • Isaacs J, Tan AC, Hanks BA, Wang X, Owzar K, Herndon JE, Antonia SJ, Piantadosi S, Khasraw M. Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage. Clin Cancer Res 2021. PubMed
  • Von Hoff DD, Clark GM, Coltman CA, Disis ML, Eckhardt SG, Ellis LM, Foti M, Garrett-Mayer E, Gonen M, Hidalgo M, Hilsenbeck SG, Littlefield JH, LoRusso PM, Lyerly HK, Meropol NJ, Patel JD, Piantadosi S, Post DA, Regan MM, Shyr Y, Tempero MA, Tepper JE, Von Roenn J, Weiner LM, Young DC, Vu NV. A grant-based experiment to train clinical investigators: the AACR/ASCO methods in clinical cancer research workshop. Clin Cancer Res 2021. PubMed
  • Wahl RL, Frey EC, Jacene HA, Kahl BS, Piantadosi S, Bianco JA, Hammes RJ, Jung M, Kasecamp W, He B, Sgouros G, Flinn IW, Swinnen LJ. Prospective SPECT-CT Organ Dosimetry-Driven Radiation-Absorbed Dose Escalation Using the In-111 (In)/Yttrium 90 (Y) Ibritumomab Tiuxetan (Zevalin) Theranostic Pair in Patients with Lymphoma at Myeloablative Dose Levels. Cancers (Basel) 2021. PubMed
  • Wang X, Piantadosi S, Le-Rademacher J, Mandrekar SJ. Statistical Considerations for Subgroup Analyses. J Thorac Oncol 2021; 16:375-380. PubMed
  • Bertagnolli MM, Anderson B, Quina A, Piantadosi S. The electronic health record as a clinical trials tool: Opportunities and challenges. Clin Trials 2020; 17:237-242. PubMed
  • Bertagnolli MM, Anderson B, Norsworthy K, Piantadosi S, Quina A, Schilsky RL, Miller RS, Khozin S. Status Update on Data Required to Build a Learning Health System. J Clin Oncol 2020. PubMed
  • Gresham G, Diniz MA, Razaee ZS, Luu M, Kim S, Hays RD, Piantadosi S, Tighiouart M, Yothers G, Ganz PA, Rogatko A. Evaluating Treatment Tolerability in Cancer Clinical Trials using the Toxicity Index. Journal of the National Cancer Institute 2020. PubMed
  • Nass SJ, Rothenberg ML, Pentz R, Hricak H, Abernethy A, Anderson K, Gee AW, Harvey RD, Piantadosi S, Bertagnolli MM, Schrag D, Schilsky RL. Accelerating anticancer drug development - opportunities and trade-offs. Nat Rev Clin Oncol 2018. PubMed
  • Walsh RR, Krismer F, Galpern WR, Wenning GK, Low PA, Halliday G, Koroshetz WJ, Holton J, Quinn NP, Rascol O, Shaw LM, Eidelberg D, Bower P, Cummings JL, Abler V, Biedenharn J, Bitan G, Brooks DJ, Brundin P, Fernandez H, Fortier P, Freeman R, Gasser T, Hewitt A, Höglinger GU, Huentelman MJ, Jensen PH, Jeromin A, Kang UJ, Kaufmann H, Kellerman L, Khurana V, Klockgether T, Kim WS, Langer C, LeWitt P, Masliah E, Meissner W, Melki R, Ostrowitzki S, Piantadosi S, Poewe W, Robertson D, Roemer C, Schenk D, Schlossmacher M, Schmahmann JD, Seppi K, Shih L, Siderowf A, Stebbins GT, Stefanova N, Tsuji S, Sutton S, Zhang J. Recommendations of the Global Multiple System Atrophy Research Roadmap Meeting. Neurology 2018; 90:74-82. PubMed
  • Gresham G, Hendifar AE, Spiegel B, Neeman E, Tuli R, Rimel BJ, Figlin RA, Meinert CL, Piantadosi S, Shinde AM. Wearable activity monitors to assess performance status and predict clinical outcomes in advanced cancer patients. NPJ Digit Med 2018; 1:27. PubMed
  • Gresham G, Schrack J, Gresham LM, Shinde AM, Hendifar AE, Tuli R, Rimel BJ, Figlin R, Meinert CL, Piantadosi S. Wearable activity monitors in oncology trials: Current use of an emerging technology. Contemp Clin Trials 2018; 64:13-21. PubMed
  • Yusen RD, Criner GJ, Sternberg AL, Au DH, Fuhlbrigge AL, Albert RK, Casaburi R, Stoller JK, Harrington KF, Cooper JAD, Diaz P, Gay S, Kanner R, MacIntyre N, Martinez FJ, Piantadosi S, Sciurba F, Shade D, Stibolt T, Tonascia J, Wise R, Bailey WC, , . The Long-Term Oxygen Treatment Trial for Chronic Obstructive Pulmonary Disease: Rationale, Design, and Lessons Learned. Ann Am Thorac Soc 2018; 15:89-101. PubMed
  • Piantadosi S. Three dimensional mathematical modeling of violin plate surfaces: An approach based on an ensemble of contour lines. PLoS ONE 2017; 12:e0171167. PubMed
  • Jacene H, Crandall J, Kasamon YL, Ambinder RF, Piantadosi S, Serena D, Kasecamp W, Wahl RL. Initial Experience with Tositumomab and I-131-Labeled Tositumomab for Treatment of Relapsed/Refractory Hodgkin Lymphoma. Mol Imaging Biol 2017; 19:429-436. PubMed
  • Daley GQ, Hyun I, Apperley JF, Barker RA, Benvenisty N, Bredenoord AL, Breuer CK, Caulfield T, Cedars MI, Frey-Vasconcells J, Heslop HE, Jin Y, Lee RT, McCabe C, Munsie M, Murry CE, Piantadosi S, Rao M, Rooke HM, Sipp D, Studer L, Sugarman J, Takahashi M, Zimmerman M, Kimmelman J. Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines. Stem Cell Reports 2016; 6:787-97. PubMed
  • Liu Z, Lin S, Deng N, McGovern DP, Piantadosi S. Sparse Inverse Covariance Estimation with L0 Penalty for Network Construction with Omics Data. J Comput Biol 2016; 23:192-202. PubMed
  • Tighiouart M, Li Q, Piantadosi S, Rogatko A. A Bayesian Adaptive Design for Combination of Three Drugs in Cancer Phase I Clinical Trials. Am J Biostat 2016; 6:1-11. PubMed
  • Biankin AV, Piantadosi S, Hollingsworth SJ. Patient-centric trials for therapeutic development in precision oncology. Nature 2015; 526:361-70. PubMed
  • Rogatko A, Cook-Wiens G, Tighiouart M, Piantadosi S. Escalation with Overdose Control is More Efficient and Safer than Accelerated Titration for Dose Finding. Entropy (Basel) 2015; 17:5288-5303. PubMed
  • Liu Z, Sun F, Braun J, McGovern DP, Piantadosi S. Multilevel regularized regression for simultaneous taxa selection and network construction with metagenomic count data. Bioinformatics 2015; 31:1067-74. PubMed
  • Liu Z, Lin S, Piantadosi S. Network construction and structure detection with metagenomic count data. BioData Min 2015; 8:40. PubMed
  • Huang P, Ou AH, Piantadosi S, Tan M. Formulating appropriate statistical hypotheses for treatment comparison in clinical trial design and analysis. Contemp Clin Trials 2014; 39:294-302. PubMed
  • Tighiouart M, Piantadosi S, Rogatko A. Dose finding with drug combinations in cancer phase I clinical trials using conditional escalation with overdose control. Stat Med 2014; 33:3815-29. PubMed