Center for Early Phase Trials

Why

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.S.
David Brighton, M.S.

Affiliate Members

Nolan A. Wages, Ph.D. (Department of Biostatistics, VCU, Richmond – since May 2022)

Funding

NIH/NCI R01CA142859 (PI: Conaway). Designs for phase I trials of combinations of agents. 2010-2013.
NIH/NCI R01CA142859 (PI: Conaway). Designs for phase I trials in heterogeneous groups. 2014-2019.
NIH/NCI K25CA181638 (PI: Wages). Phase I designs for combined immunotherapies in cancer. 2014-2019.
NIH/NCI R03CA238966 (PI: Wages). Dose-finding designs for adoptive cell therapy trials. 2019-2021.
NIH/NCI R01CA247932 (PI: Wages). Dose finding designs for late-onset toxicities. 2021-2024.
NIH/NICHD R03HD111715 (PI: Conaway, mPI: Stevenson). An evaluation of composite endpoints using data from the EXCITE trial. 2023-2025.

Ph.D. Students

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. Current.

Design Publications

General Early-Phase Trial Design Patient Heterogeneity Immunotherapies & Targeted Agents Drug Combinations Multiple treatment schedules Book chapters

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, 2^nd 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, 2^nd 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, 2^nd 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, 3^nd 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, 1^st 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, 2^nd 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

Investigator-initiated clinical trials (single and multi-site) Clinical Trial Results:

Supplemental Materials

Supplementary files for Wages, Iasonos, O’Quigley, Conaway (Pharm Stat, 2020) Supplementary files for Conaway and Petroni (CCR, 2019)