Lorenzo Trippa, PhD

Lorenzo Trippa, PhD

Contact Information

Office Phone Number

617-582-9133

Biography

Lorenzo Trippa, PhD

Lorenzo Trippa, PhD, is a Professor in the Department of Biostatistics and Computational Biology at Dana-Farber, and a Professor in the Department of Biostatistics at the Harvard T.H. Chan School of Public Health. His research interests include clinical trials design; Bayesian nonparametrics; the development of prediction models in personalized medicine; computational methods for Bayesian adaptive designs; computational methods for Bayesian inference; and meta-analyses in personalized medicine. Trippa is a winner of the Savage PhD Thesis Award from the International Society for Bayesian Analysis. He holds a PhD in Statistics from Bocconi University, Milan, Italy, and an MS in Statistics (cum laude) from Milan’s Bicocca University.

Researcher

Physician

Professor, Harvard University
Co-Director, Program in Regulatory Science

Research

    My research is focused on the following topics: Clinical Trials Design, Bayesian Nonparametrics, Development of Prediction Models in Personalized Medicine, Computational Methods for Bayesian Inference, Meta Analyses in Personalized Medicine

    Research Departments

    Publications

      • Uncertainty directed factorial clinical trials. Biostatistics. 2024 Feb 08. View in: Pubmed

      • Response-guided neoadjuvant sacituzumab govitecan for localized triple-negative breast cancer: results from the NeoSTAR trial. Ann Oncol. 2024 Mar; 35(3):293-301. View in: Pubmed

      • Clinical trials that leverage external data: Do we need more transparent protocols and statistical plans? Eur J Cancer. 2024 Jan; 196:113443. View in: Pubmed

      • Inaugural Results of the Individualized Screening Trial of Innovative Glioblastoma Therapy: A Phase II Platform Trial for Newly Diagnosed Glioblastoma Using Bayesian Adaptive Randomization. J Clin Oncol. 2023 Dec 20; 41(36):5524-5535. View in: Pubmed

      • Bayesian combinatorial MultiStudy factor analysis. Ann Appl Stat. 2023 Sep; 17(3):2212-2235. View in: Pubmed

      • External Control Arms and Data Analysis Methods in Nonrandomized Trial of Patients With Glioblastoma. JAMA Oncol. 2023 07 01; 9(7):1006-1007. View in: Pubmed

      • Looking ahead in early-phase trial design to improve the drug development process: examples in oncology. BMC Med Res Methodol. 2023 06 29; 23(1):151. View in: Pubmed

      • Accessible Data Collections for Improved Decision Making in Neuro-Oncology Clinical Trials. Clin Cancer Res. 2023 06 13; 29(12):2194-2198. View in: Pubmed

      • Comment: Advancing Clinical Trials with Novel Designs and Implementations. Stat Sci. 2023 May; 38(2):216-218. View in: Pubmed

      • Personalised progression prediction in patients with monoclonal gammopathy of undetermined significance or smouldering multiple myeloma (PANGEA): a retrospective, multicohort study. Lancet Haematol. 2023 Mar; 10(3):e203-e212. View in: Pubmed

      • Combining Breast Cancer Risk Prediction Models. Cancers (Basel). 2023 Feb 08; 15(4). View in: Pubmed

      • Cross-Study Replicability in Cluster Analysis. Stat Sci. 2023 May; 38(2):303-316. View in: Pubmed

      • Validation of Predictive Analyses for Interim Decisions in Clinical Trials. JCO Precis Oncol. 2023 02; 7:e2200606. View in: Pubmed

      • Prospectively shared control data across concurrent randomised clinical trials. Eur J Cancer. 2023 03; 181:18-20. View in: Pubmed

      • Immune biomarkers of response to immunotherapy in patients with high-risk smoldering myeloma. Cancer Cell. 2022 11 14; 40(11):1358-1373.e8. View in: Pubmed

      • The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 10 02; 13(1):5783. View in: Pubmed

      • A validation of models for prediction of pathogenic variants in mismatch repair genes. Genet Med. 2022 10; 24(10):2155-2166. View in: Pubmed

      • Novel Clinical Trial Designs in Neuro-Oncology. Neurotherapeutics. 2022 10; 19(6):1844-1854. View in: Pubmed

      • Designing and conducting adaptive trials to evaluate interventions in health services and implementation research: practical considerations. BMJ Med. 2022; 1(1). View in: Pubmed

      • Genetic subtypes of smoldering multiple myeloma are associated with distinct pathogenic phenotypes and clinical outcomes. Nat Commun. 2022 06 15; 13(1):3449. View in: Pubmed

      • Empirical Evaluations of Clinical Trial Designs. JAMA Netw Open. 2022 05 02; 5(5):e2211620. View in: Pubmed

      • Clonal hematopoiesis is associated with increased risk of progression of asymptomatic Waldenström macroglobulinemia. Blood Adv. 2022 04 12; 6(7):2230-2235. View in: Pubmed

      • PREDICTION OF HEREDITARY CANCERS USING NEURAL NETWORKS. Ann Appl Stat. 2022 Mar; 16(1):495-520. View in: Pubmed

      • Prevalence of monoclonal gammopathies and clinical outcomes in a high-risk US population screened by mass spectrometry: a multicentre cohort study. Lancet Haematol. 2022 May; 9(5):e340-e349. View in: Pubmed

      • Approximating the Operating Characteristics of Bayesian Uncertainty Directed Trial Designs. J Stat Plan Inference. 2022 Dec; 221:90-99. View in: Pubmed

      • A Bayesian Multi-Outcome Analysis of Fine Particulate Matter and Cardiorespiratory Hospitalizations. Epidemiology. 2022 03 01; 33(2):176-184. View in: Pubmed

      • Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial. NPJ Breast Cancer. 2022 Feb 16; 8(1):18. View in: Pubmed

      • The use of external control data for predictions and futility interim analyses in clinical trials. Neuro Oncol. 2022 02 01; 24(2):247-256. View in: Pubmed

      • Attenuated response to SARS-CoV-2 vaccine in patients with asymptomatic precursor stages of multiple myeloma and Waldenstrom macroglobulinemia. Cancer Cell. 2022 01 10; 40(1):6-8. View in: Pubmed

      • Inference in response-adaptive clinical trials when the enrolled population varies over time. Biometrics. 2023 03; 79(1):381-393. View in: Pubmed

      • Leveraging external data in the design and analysis of clinical trials in neuro-oncology. Lancet Oncol. 2021 10; 22(10):e456-e465. View in: Pubmed

      • Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial. Trials. 2021 Sep 25; 22(1):651. View in: Pubmed

      • Prospective Study Testing a Simplified Paclitaxel Premedication Regimen in Patients with Early Breast Cancer. Oncologist. 2021 11; 26(11):927-933. View in: Pubmed

      • Nivolumab in combination with cabozantinib for metastatic triple-negative breast cancer: a phase II and biomarker study. NPJ Breast Cancer. 2021 Aug 25; 7(1):110. View in: Pubmed

      • Integration of survival data from multiple studies. Biometrics. 2021 Jun 30. View in: Pubmed

      • KMDATA: a curated database of reconstructed individual patient-level data from 153 oncology clinical trials. Database (Oxford). 2021 06 26; 2021. View in: Pubmed

      • Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. J Clin Oncol. 2021 07 20; 39(21):2375-2385. View in: Pubmed

      • Impact of HER2 Heterogeneity on Treatment Response of Early-Stage HER2-Positive Breast Cancer: Phase II Neoadjuvant Clinical Trial of T-DM1 Combined with Pertuzumab. Cancer Discov. 2021 10; 11(10):2474-2487. View in: Pubmed

      • Perfect Sampling of the Posterior in the Hierarchical Pitman-Yor Process. Bayesian Anal. 2022 Sep; 17(3):685-709. View in: Pubmed

      • Assessment of Simulated SARS-CoV-2 Infection and Mortality Risk Associated With Radiation Therapy Among Patients in 8 Randomized Clinical Trials. JAMA Netw Open. 2021 03 01; 4(3):e213304. View in: Pubmed

      • The effects of releasing early results from ongoing clinical trials. Nat Commun. 2021 02 05; 12(1):801. View in: Pubmed

      • Rationale and design of the Novel Uses of adaptive Designs to Guide provider Engagement in Electronic Health Records (NUDGE-EHR) pragmatic adaptive randomized trial: a trial protocol. Implement Sci. 2021 01 07; 16(1):9. View in: Pubmed

      • Reply to "Keynote 48: Is it really for everyone?" Oral Oncol. 2021 04; 115:105108. View in: Pubmed

      • Meta-Analysis of PD-L1 Expression As a Predictor of Survival After Checkpoint Blockade. JCO Precis Oncol. 2020 Nov; 4:1196-1206. View in: Pubmed

      • Effect of Eribulin With or Without Pembrolizumab on Progression-Free Survival for Patients With Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2020 10 01; 6(10):1598-1605. View in: Pubmed

      • Oncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center. Breast Cancer Res Treat. 2021 Jan; 185(1):215-227. View in: Pubmed

      • TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker. Ann Oncol. 2020 11; 31(11):1518-1525. View in: Pubmed

      • Shared and Usable Data From Phase 1 Oncology Trials-An Unmet Need. JAMA Oncol. 2020 07 01; 6(7):980-981. View in: Pubmed

      • Optimality of testing procedures for survival data in the nonproportional hazards setting. Biometrics. 2021 06; 77(2):587-598. View in: Pubmed

      • Clonal hematopoiesis is associated with adverse outcomes in multiple myeloma patients undergoing transplant. Nat Commun. 2020 06 12; 11(1):2996. View in: Pubmed

      • Phase I dose-escalation trial of tucatinib in combination with trastuzumab in patients with HER2-positive breast cancer brain metastases. Ann Oncol. 2020 09; 31(9):1231-1239. View in: Pubmed

      • Genomic Profiling of Smoldering Multiple Myeloma Identifies Patients at a High Risk of Disease Progression. J Clin Oncol. 2020 07 20; 38(21):2380-2389. View in: Pubmed

      • Prediction of Outcomes with a Computational Biology Model in Newly Diagnosed Glioblastoma Patients Treated with Radiation Therapy and Temozolomide. Int J Radiat Oncol Biol Phys. 2020 11 01; 108(3):716-724. View in: Pubmed

      • Keynote 48: Is it really for everyone? Oral Oncol. 2020 06; 105:104762. View in: Pubmed

      • A Quantitative Framework for Modeling COVID-19 Risk During Adjuvant Therapy Using Published Randomized Trials of Glioblastoma in the Elderly. Neuro Oncol. 2020 Apr 27. View in: Pubmed

      • Avoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study. J Clin Oncol. 2020 07 20; 38(21):2390-2397. View in: Pubmed

      • Sensitive Detection of Minimal Residual Disease in Patients Treated for Early-Stage Breast Cancer. Clin Cancer Res. 2020 06 01; 26(11):2556-2564. View in: Pubmed

      • Pathologic Complete Response after Neoadjuvant Chemotherapy and Impact on Breast Cancer Recurrence and Survival: A Comprehensive Meta-analysis. Clin Cancer Res. 2020 06 15; 26(12):2838-2848. View in: Pubmed

      • A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer. Clin Breast Cancer. 2020 06; 20(3):238-245. View in: Pubmed

      • Identifying ERBB2 Activating Mutations in HER2-Negative Breast Cancer: Clinical Impact of Institute-Wide Genomic Testing and Enrollment in Matched Therapy Trials. JCO Precis Oncol. 2019; 3. View in: Pubmed

      • To randomize, or not to randomize, that is the question: using data from prior clinical trials to guide future designs. Neuro Oncol. 2019 10 09; 21(10):1239-1249. View in: Pubmed

      • Phase I/II trial of the CXCR4 inhibitor plerixafor in combination with bortezomib as a chemosensitization strategy in relapsed/refractory multiple myeloma. Am J Hematol. 2019 11; 94(11):1244-1253. View in: Pubmed

      • A phase II study of cabozantinib alone or in combination with trastuzumab in breast cancer patients with brain metastases. Breast Cancer Res Treat. 2020 Jan; 179(1):113-123. View in: Pubmed

      • Lessons Learned from Deescalation Trials in Favorable Risk HPV-Associated Squamous Cell Head and Neck Cancer-A Perspective on Future Trial Designs. Clin Cancer Res. 2019 12 15; 25(24):7281-7286. View in: Pubmed

      • Deviation from the Proportional Hazards Assumption in Randomized Phase 3 Clinical Trials in Oncology: Prevalence, Associated Factors, and Implications. Clin Cancer Res. 2019 11 01; 25(21):6339-6345. View in: Pubmed

      • Frequentist operating characteristics of Bayesian optimal designs via simulation. Stat Med. 2019 09 20; 38(21):4026-4039. View in: Pubmed

      • Design and Evaluation of an External Control Arm Using Prior Clinical Trials and Real-World Data. Clin Cancer Res. 2019 08 15; 25(16):4993-5001. View in: Pubmed

      • Divining responder populations from survival data. Ann Oncol. 2019 06 01; 30(6):1005-1013. View in: Pubmed

      • Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial. Clin Breast Cancer. 2019 12; 19(6):399-404. View in: Pubmed

      • Progression Risk Stratification of Asymptomatic Waldenström Macroglobulinemia. J Clin Oncol. 2019 06 01; 37(16):1403-1411. View in: Pubmed

      • Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT): A Bayesian Adaptive Platform Trial to Develop Precision Medicines for Patients With Glioblastoma. JCO Precis Oncol. 2019; 3. View in: Pubmed

      • Multi-study factor analysis. Biometrics. 2019 03; 75(1):337-346. View in: Pubmed

      • Bayesian adaptive design: the future for regional anesthesia trials? Reg Anesth Pain Med. 2019 Mar 02. View in: Pubmed

      • Bayesian Adaptive Randomization in Dose-Finding Trials. JAMA Netw Open. 2018 12 07; 1(8):e186075. View in: Pubmed

      • Bortezomib overcomes the negative impact of CXCR4 mutations on survival of Waldenstrom macroglobulinemia patients. Blood. 2018 12 13; 132(24):2608-2612. View in: Pubmed

      • The clinical trials landscape for glioblastoma: is it adequate to develop new treatments? Neuro Oncol. 2018 07 05; 20(8):1034-1043. View in: Pubmed

      • Efficient computation of the joint probability of multiple inherited risk alleles from pedigree data. Genet Epidemiol. 2018 09; 42(6):528-538. View in: Pubmed

      • A phase 2 study of modified lenalidomide, bortezomib and dexamethasone in transplant-ineligible multiple myeloma. Br J Haematol. 2018 07; 182(2):222-230. View in: Pubmed

      • Adding experimental arms to platform clinical trials: randomization procedures and interim analyses. Biostatistics. 2018 04 01; 19(2):199-215. View in: Pubmed

      • Hazards of Hazard Ratios - Deviations from Model Assumptions in Immunotherapy. N Engl J Med. 2018 03 22; 378(12):1158-1159. View in: Pubmed

      • Leveraging molecular datasets for biomarker-based clinical trial design in glioblastoma. Neuro Oncol. 2017 Jul 01; 19(7):908-917. View in: Pubmed

      • Designing Clinical Trials That Accept New Arms: An Example in Metastatic Breast Cancer. J Clin Oncol. 2017 Sep 20; 35(27):3160-3168. View in: Pubmed

      • Feasibility of Ultra-High-Throughput Functional Screening of Melanoma Biopsies for Discovery of Novel Cancer Drug Combinations. Clin Cancer Res. 2017 Aug 15; 23(16):4680-4692. View in: Pubmed

      • Bayesian Nonparametric Ordination for the Analysis of Microbial Communities. J Am Stat Assoc. 2017; 112(520):1430-1442. View in: Pubmed

      • Bayesian response-adaptive designs for basket trials. Biometrics. 2017 09; 73(3):905-915. View in: Pubmed

      • Prognostic role of circulating exosomal miRNAs in multiple myeloma. Blood. 2017 04 27; 129(17):2429-2436. View in: Pubmed

      • Bayesian Baskets: A Novel Design for Biomarker-Based Clinical Trials. J Clin Oncol. 2017 Feb 20; 35(6):681-687. View in: Pubmed

      • Bayesian adaptive randomization in a clinical trial to identify new regimens for MDR-TB: the endTB trial. Int J Tuberc Lung Dis. 2016 12 01; 20(12):8-12. View in: Pubmed

      • A Bayesian response-adaptive trial in tuberculosis: The endTB trial. Clin Trials. 2017 Feb; 14(1):17-28. View in: Pubmed

      • Robust lineage reconstruction from high-dimensional single-cell data. Nucleic Acids Res. 2016 08 19; 44(14):e122. View in: Pubmed

      • Mitigating Bias in Generalized Linear Mixed Models: The Case for Bayesian Nonparametrics. Stat Sci. 2016 Feb; 31(1):80-95. View in: Pubmed

      • Optimal Bayesian adaptive trials when treatment efficacy depends on biomarkers. Biometrics. 2016 06; 72(2):414-21. View in: Pubmed

      • On the restricted mean survival time curve in survival analysis. Biometrics. 2016 Mar; 72(1):215-21. View in: Pubmed

      • Unbiased estimation for response adaptive clinical trials. Stat Methods Med Res. 2017 Oct; 26(5):2376-2388. View in: Pubmed

      • Getting it first versus getting it right: weighing the value of and evidence for progression-free survival as a surrogate endpoint for overall survival in glioblastoma. Neuro Oncol. 2015 May; 17(5):765-6. View in: Pubmed

      • Clinical implementation of integrated whole-genome copy number and mutation profiling for glioblastoma. Neuro Oncol. 2015 Oct; 17(10):1344-55. View in: Pubmed

      • Combining progression-free survival and overall survival as a novel composite endpoint for glioblastoma trials. Neuro Oncol. 2015 Aug; 17(8):1106-13. View in: Pubmed

      • Bifurcation analysis of single-cell gene expression data reveals epigenetic landscape. Proc Natl Acad Sci U S A. 2014 Dec 30; 111(52):E5643-50. View in: Pubmed

      • A toolbox for spatiotemporal analysis of voltage-sensitive dye imaging data in brain slices. PLoS One. 2014; 9(9):e108686. View in: Pubmed

      • Bayesian designs and the control of frequentist characteristics: a practical solution. Biometrics. 2015 Mar; 71(1):218-226. View in: Pubmed

      • Brain Malignancy Steering Committee clinical trials planning workshop: report from the Targeted Therapies Working Group. Neuro Oncol. 2015 Feb; 17(2):180-8. View in: Pubmed

      • Subgroup-Based Adaptive (SUBA) Designs for Multi-Arm Biomarker Trials. Stat Biosci. 2016 Jun; 8(1):159-180. View in: Pubmed

      • Cross-study validation for the assessment of prediction algorithms. Bioinformatics. 2014 Jun 15; 30(12):i105-12. View in: Pubmed

      • Progression-free survival: too much risk, not enough reward? Neuro Oncol. 2014 May; 16(5):615-6. View in: Pubmed

      • Risk prediction for late-stage ovarian cancer by meta-analysis of 1525 patient samples. J Natl Cancer Inst. 2014 Apr 03; 106(5). View in: Pubmed

      • A comparison of Bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials. Stat Med. 2014 Jun 15; 33(13):2206-21. View in: Pubmed

      • Statistical tools and R software for cancer driver probabilities. Methods Mol Biol. 2014; 1101:113-34. View in: Pubmed

      • Biomarker-based adaptive trials for patients with glioblastoma--lessons from I-SPY 2. Neuro Oncol. 2013 Aug; 15(8):972-8. View in: Pubmed

      • Reply to B. Freidlin et al. J Clin Oncol. 2013 Mar 01; 31(7):970-1. View in: Pubmed

      • Defining Predictive Probability Functions for Species Sampling Models. Stat Sci. 2013; 28(2):209-222. View in: Pubmed

      • Bayesian adaptive randomized trial design for patients with recurrent glioblastoma. J Clin Oncol. 2012 Sep 10; 30(26):3258-63. View in: Pubmed

      • Bayesian enrichment strategies for randomized discontinuation trials. Biometrics. 2012 Mar; 68(1):203-11. View in: Pubmed

      • The multivariate beta process and an extension of the Polya tree model. Biometrika. 2011 Mar; 98(1):17-34. View in: Pubmed

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      60 Longwood CLS 11017 Brooklinne, MA 02446
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      Dana-Farber Cancer Institute

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      Dana-Farber Cancer Institute

      60 Longwood CLS 11017 Brooklinne, MA 02446
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