- Designs and some critical issues of Phase I, II, and III clinical trials
- Dose-Toxicity Bayesian models in cancer Phase I clinical trials
- A novel toxicity score system to measure the multiple toxicities per patient quantitatively and comprehensively in Phase I clinical trials
- Methods treating disease response as a continuous variable instead of using RECIST in Phase II clinical trials
Areas of Interest
- Bayesian Analysis
- Cancer Prevention
- Clinical Trials
- HIV/AIDS Prevention
Affiliations & Activities
1. ID-NETS (Isotonic Design using Normalized Equivalence Toxicity Score).
ID-NETS is a novel semi-parametric Phase I design which is developed by integration of original isotonic design and my NETS system. ID-NETS can substantially improve the accuracy of MTD determination and trial efficiency by fully utilizing all toxicities of each patient and treating toxicity response as a quasi-continuous variable instead of a binary indicator of DLT. ID-NETS is also very robust because it only assumes a monotonically increasing dose toxicity relationship instead of any parametric model. ID-NETS is particularly appropriate for clinical trials which have no reliable parametric model for dose toxicity relationship and the target toxicity level is outside the range of 18-33% of DLT. ID-NETS©TM is an interactive and user-friendly statistical software to implement the design ID-NETS in Phase I clinical trials. The standalone version of the software can be downloaded freely from the website: https://winshipbbisr.emory.edu/IDNETS.html
2. EWOC-NETS (Escalation with Overdose Control using Normalized Equivalence Toxicity Score).
EWOC-NETS is a novel Bayesian adaptive design which is a combination of EWOC and my NETS system. EWOC-NETS not only retains all the advantages of EWOC, but also treats toxicity response as a quasi-continuous variable instead of a binary indicator of DLT, fully utilizes all toxicity information, and improves the accuracy of MTD estimation and the efficiency of Phase I trials. EWOC-NETS©TM is an interactive and user-friendly statistical software to implement the design EWOC-NETS in Phase I clinical trials. The standalone version of the software can be downloaded freely from the website: https://winshipbbisr.emory.edu/EWOCNETS.html
3. Standard 3+3 Design simulator
Standard 3+3 with or without dose de-escalation designs are still most widely used in cancer Phase I clinical trials for their simplicity and robustness. In clinical practice and grant applications, it is necessary to provide the operating characteristics of Phase I clinical trials at the planning stage. Therefore I have developed an interactive and user-friendly software called Standard-3+3-design©TM to estimate the operating characteristics of Phase I clinical trials using Standard 3+3 designs. The standalone version of the software is available for free download and the web-based version can be directly used online at the website: https://winshipbbisr.emory.edu/3_3.html
4. Matlab Codes (http://web1.sph.emory.edu/users/zchen38/MATLABCode.pdf ) for the Publication
(Chen Z, Chen X. Exact Calculation of Minimum Sample Size for Estimating a Possion Parameter, Communication in Statistics - Theory and Methods. 2014, In press)
5. Development of an interactive statistical software for calculation of the operating characteristics of Phase I clinical trials using standard 3+3 design. (Using R shiny).
6. Development of an interactive statistical software for Phase I clinical trials using EWOC-NETS design. (Using R shiny).
- Harvey RD, Zhang C, Lonial S, Kaufman JL, Chen Z., 2019, Reply to African American patients may or may not have poorer response rates after monoclonal antibody treatment: Overreliance on P values in underpowered studies., Cancer, In Press,
- Chen Z, Zheng Y, Wang Z, Kutner M, Curran WJ, Kowalski J., 2018, Interactive calculator for operating characteristics of phase I cancer clinical trials using standard 3+3 designs., Contemporary Clinical Trials Communication, 7, 145-153
- Chen Z, Li Z, Zhuang R, Yuan Y, Kutner M, Owonikoko T, Curran WJ, Kowalski J, 2017, Adaptive Estimation of Personalized Maximum Tolerated Dose in Cancer Phase I Clinical Trials Based on All Toxicities and Individual Genomic Profile, PLOS one, 12, e0170187. doi:10.1371/journal.pone.0170187
- Chen Z, Chen X. , 2016, Exact Calculation of Minimum Sample Size for Estimating a Poisson Parameter., Communications in Statistics – Theory and Methods. , 45, 4692-4715
- Chen Z, Yuan Y, Li Z, Kutner M, Owonikoko TK, Curran W, Khuri F, Kowalski J. , 2015, Dose Escalation with Over Dose and Under Dose Control for Phase I/II Clinical Trials, Contemporary Clinical Trials, 43, 133-141
- Chen Z, Chen X, 2015, Rigorous Error Control Methods for Estimating Means of Bounded Random Variables, Journal of Statistical Planning and Inference , 157-158, 54-76
- Chen Z, Cui Y, Owonikoko TK, Wang Z, Li Z, Luo R, Kutner M, Khuri FR, Kowalski J., 2014, Escalation with overdose control using all toxicities and time to event toxicity data in cancer Phase I clinical trials., Contemporary Clinical Trials, 37(2), 322-32
- Zhao Y, Chen Z, Huang X, Tighiouart M, 2013, Editorial: Adaptive and Sequential Methods for Clinical Trials, Journal of Probability and Statistics, , DOI:10.1155/2013/386058
- Chen Z, Chen X, 2013, Exact Group Sequential Methods for Estimating a Binomial Proportion, Journal of Probability and Statistics, , DOI:10.1155/2013/603297
- Chen Z, Wang Z, Wang H, Owonikoko T, Kowalski J, Khuri F, 2013, Interactive Software “Isotonic Design using Normalized Equivalent Toxicity Score (ID-NETS©TM)” for Cancer Phase I Clinical Trials, The Open Medical Informatics Journal, 7, 8-17
- Chen Z, Tighiouart M, Kowalski J. , 2012, Dose Escalation with Overdose Control using a Quasi-Continuous Toxicity Score in Cancer Phase I Clinical Trials, Contemporary Clinical Trials, 33(5), 949-58
- Chen Z, Zhao Y, Cui Y, Kowalski J, 2012, Methodology and Application of Adaptive and Sequential Approaches in Contemporary Clinical Trials, Journal of Probability and Statistics, , DOI:10.1155/2012/527351
- Chen Z, Krailo MD, Azen SP, Tighiouart M., 2010, A Novel Toxicity Scoring System Treating Toxicity Response as a Quasi-Continuous Variable in Phase I Clinical Trials, Contemporary Clinical Trials, 31, 473-482
- Chen Z, Krailo MD, Sun J, Azen SP, 2009, Range and trend of expected toxicity level (ETL) in standard A+B designs: A report from the children's oncology group, Contemporary Clinical Trials, 30(2), 123-8.
- Chen Z, Wu AH, Gauderman J, Bernstein L, Ma H, Pike MC, Ursin G. , 2004, Does mammographic density reflect ethnic differences in breast cancer incidence rates?, American Journal of Epidemiology, 159, 140-147