To change the way clinical research is done so that treatments that positively impact the lives of patients can be discovered and advanced.
We have established that a well-performing early-phase design can have a substantial impact on drug development, increasing the chances that an effective therapy will be identified and put forward for therapeutic use.
How
Empower and educate clinical investigators through team science, including refining study objectives and tailoring designs to meet those objectives.
Create early phase designs for targeted agents, immunotherapies and multi-drug combinations, incorporating patient heterogeneity, delayed toxicities, and personalized dosing.
Develop free user-friendly web applications for designing and conducting early-phase clinical trials, which facilitates efficient team science.
Current Members
Mark R. Conaway, Ph.D. (Director)
Gina R. Petroni, Ph.D. (Co-Director)
Bethany J. Horton, Ph.D.
Nikole Varhegyi, M.S.
Shiyi Shen, M.A.
David Brighton, M.S.
Cherie Miner, B.A.
Affiliate Members
Nolan A. Wages, Ph.D. (Department of Biostatistics, VCU, Richmond VA – since May 2022)
Evan Bagley, Ph.D. (Department of Public Health Sciences, MUSC, Charleston SC – since May 2024)
Dunbar, S. Order Restricted Inference with Applications to Phase I Clinical Trials in Oncology. Department of Statistics, University of Virginia. Advisors: Mark Conaway and Shyamal Peddada. May 2000.
Xue, Y. Biomarkers in Phase I Clinical Trials. Department of Statistics, University of Virginia. Advisors: Mark Conaway and Feifang Hu. May 2014.
Tait, C. Early-phase dose-finding for bivariate outcomes. Department of Statistics, University of Virginia. Advisor: Nolan Wages. May 2015.
Helman, JE. Dose Modifications in Phase I trials. Department of Statistics, University of Virginia. Advisors: Mark Conaway and Karen Kafadar. May 2023.
Bagley, E. Phase I cancer clinical trial designs for adoptive cell therapies. Department of Statistics, University of Virginia. Advisors: Nolan Wages and Karen Kafadar. May 2023.
Celum, C. Patient Heterogeneity in Phase I trials. Department of Statistics, University of Virginia. Advisors: Mark Conaway and Karen Kafadar. May 2025.
Conaway MR, Petroni GR “Dose-Finding and Dose-ranging Studies”Principles and Practice of Clinical Trials. 2021; eds. Steven Piantadosi and Curtis L. Meinert (Eds). Springer Nature.
Conaway MR “Dose-Finding Using the Continual Reassessment Method”Oncology Clinical Trials: Successful Design, Conduct, and Analysis, 2nd edition. 2018; eds. WK Kelly, DO, S Halabi, PhD, Springer Publishing Company
Wages, NA “Innovative Phase I Clinical Trials”Oncology Clinical Trials: Successful Design, Conduct, and Analysis, 2nd edition. 2018; eds. WK Kelly, DO, S Halabi, PhD, Springer Publishing Company
Wang H, Petroni GR “Design of Phase II Trials’Oncology Clinical Trials: Successful Design, Conduct, and Analysis, 2nd edition. 2018; eds. WK Kelly, DO, S Halabi, PhD, Springer Publishing Company
Conaway MR “Patient Heterogeneity in Dose-Finding Trials” Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials. 2017; eds. John O’Quigley, Alexia Iasonos, Björn Bornkamp. CRC Press
Conaway MR, Wages NA “Phase I Trials and Dose Finding”Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis. 2016; eds. Stephen L. George, Xiaofei Wang, Herbert Pang. CRC Press
Petroni GR, Conaway, MR “Phase II trials with combined response and toxicity endpoints” Handbook of Statistics in Clinical Oncology, 3nd edition. 2011; ed. Crowley, J. Marcel Dekker
Wang H, Conaway MR, Petroni, GR “Phase II Trial Design”Oncology Clinical Trials: Successful Design, Conduct, and Analysis, 1st edition. 2010; eds. Halabi, S. and Kelly, W. Springer Publishing Company
Petroni, GR “Design Issues for Early-Stage Clinical Trials for Cancer Vaccines”Immunotherapy of Cancer. 2006; ed. Nora Disis. Humana Press
Petroni GR, Conaway, MR “Phase II trials with combined response and toxicity endpoints”Handbook of Statistics in Clinical Oncology, 2nd edition. 2004; ed. Crowley, J. Marcel Dekker
Petroni GR, Conaway, MR “Phase II trials with combined response and toxicity endpoints”Handbook of Statistics in Clinical Oncology. 2001; ed. Crowley, J. Marcel Dekker
Implementation
Jones DR, Phase I Trial of Induction Histone Deacetylase and Proteasome Inhibition Followed by Surgery in Clinical Stage T2-3N0/1M0 Non-small Cell Lung Cancer (Lung 5), NCT00731952, 2006
Slingluff CL, A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients (MEL58), NCT01585350, 2012
Read PW, Phase 1/2 Study to Determine Optimal Dose for Treating Bone Metastases Using Novel STAT-RT Workflow, NCT02145286, 2014
Slingluff CL, A phase I/II trial of long peptide vaccine plus TLR agonists (Mel 60), NCT02126579, 2014
Portell C, Optimal dose finding study of ABT-199 and ibrutinib in MCL (ABT-199), NCT02419560, 2015
Slingluff CL, Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma (Mel63), NCT02425306, 2015
Lau C, Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation, NCT03072589, 2017
Dillon P, A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy (Breast49), NCT03473639, 2018
Douvas M, Phase I study of inotuzumab with augmented BFM re-Induction for younger adults with relapsed/refractory B-cell ALL, NCT03962465, 2019
Slingluff CL, Melanoma vaccine against neoantigen and shared antigens by CD40 activation and TLR agonists in patients with melanoma (Mel66), NCT04364230, 2020
Ballen K, Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MF and CMML (HSCT 002), NCT05233618, 2022
Marchi E, Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL (PTCL 002), NCT03240211, 2024
