Grant Number:	1R01CA193878-01A1 Interpret this number
Primary Investigator:	Ning, Jing
Organization:	University Of Tx Md Anderson Can Ctr
Project Title:	Comparative Effectiveness of Cancer Research: Use Data From Multiple Sources
Fiscal Year:	2016

¿ DESCRIPTION (provided by applicant): Although comparative effectiveness research (CER) in oncology has attracted substantial attention to provide timely treatment comparisons and improve health outcomes, considerable methodological gaps remain for utilizing multiple sources of data together with efficient statistical methods to assemble evidence in CER. The proposed study is directly motivated by our collaborations with breast cancer medical oncologists and surgeons in the investigation of inflammatory breast cancer (IBC), a rare but aggressive form of breast cancer. The primary objective of this proposal is to develop statistical methods and risk prediction models by combining cohort data containing detailed tumor biology variables with aggregate information with or without sampling error from population-based registry databases. In this project, (Aim 1) we propose statistical methods to utilize aggregate information from external data when analyzing primary cohort data with individual patient level data under both parametric and semiparametric models for survival data, and to provide a test procedure to evaluate the comparability of the information from primary cohort data and that from external data. We will further generalize the approaches to account for uncertainty of the aggregate information in the estimation and inference procedures for survival data (Aim 2). Furthermore, (Aim 3) we will link the primary cohort data with detailed risk profiles to external data without detailed risk factors to develop a novel comprehensive IBC-specific mortality risk prediction model, and provide an estimating approach to evaluate the performance of the established risk prediction model. From an application perspective, our proposed methods of maximizing the use of existing IBC cohort data by combining them with external registry databases is cost-effective and may directly improve evidence-based treatment guidelines for IBC patients. Although motivated by IBC research, the statistical methods will be useful for addressing the challenges of CER in any chronic disease, especially for rare diseases. All software for analytical and statistical tools developed in this project, once validated, will be made available to the broader research community.




Conditional Independence Test of Failure and Truncation Times: Essential Tool for Method Selection.
Authors: Ning J. , Pak D. , Zhu H. , Qin J. .
Source: Computational Statistics & Data Analysis, 2022 Apr; 168, .
EPub date: 2021-11-19 00:00:00.0.
PMID: 34898770
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Estimation and inference of predictive discrimination for survival outcome risk prediction models.
Authors: Li R. , Ning J. , Feng Z. .
Source: Lifetime Data Analysis, 2022 04; 28(2), p. 219-240.
EPub date: 2022-01-21 00:00:00.0.
PMID: 35061146
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Estimation and inference of predictive discrimination for survival outcome risk prediction models.
Authors: Li R. , Ning J. , Feng Z. .
Source: Lifetime Data Analysis, 2022 04; 28(2), p. 219-240.
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PMID: 35061146
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Regression modeling of restricted mean survival time for left-truncated right-censored data.
Authors: Rong R. , Ning J. , Zhu H. .
Source: Statistics In Medicine, 2022-03-28 00:00:00.0; , .
EPub date: 2022-03-28 00:00:00.0.
PMID: 35708238
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Semiparametric copula-based regression modeling of semi-competing risks data.
Authors: Zhu H. , Lan Y. , Ning J. , Shen Y. .
Source: Communications In Statistics: Theory And Methods, 2022; 51(22), p. 7830-7845.
EPub date: 2021-02-09 00:00:00.0.
PMID: 36353187
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Semiparametric isotonic regression modelling and estimation for group testing data.
Authors: Yuan A. , Piao J. , Ning J. , Qin J. .
Source: The Canadian Journal Of Statistics = Revue Canadienne De Statistique, 2021 Sep; 49(3), p. 659-677.
EPub date: 2020-10-28 00:00:00.0.
PMID: 34690407
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Evaluation of competing risks prediction models using polytomous discrimination index.
Authors: Ding M. , Ning J. , Li R. .
Source: The Canadian Journal Of Statistics = Revue Canadienne De Statistique, 2021 Sep; 49(3), p. 731-753.
EPub date: 2020-11-20 00:00:00.0.
PMID: 34707327
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ESTROGEN RECEPTOR EXPRESSION ON BREAST CANCER PATIENTS' SURVIVAL UNDER SHAPE RESTRICTED COX REGRESSION MODEL.
Authors: Qin J. , Deng G. , Ning J. , Yuan A. , Shen Y. .
Source: The Annals Of Applied Statistics, 2021 Sep; 15(3), p. 1291-1307.
PMID: 34745408
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Addressing patient heterogeneity in disease predictive model development.
Authors: Gao X. , Shen W. , Ning J. , Feng Z. , Hu J. .
Source: Biometrics, 2021-06-28 00:00:00.0; , .
EPub date: 2021-06-28 00:00:00.0.
PMID: 34184256
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A Bayesian hierarchical monitoring design for phase II cancer clinical trials: Incorporating information on response duration into monitoring rules.
Authors: Wang J. , Ma J. , Cai C. , Daver N. , Ning J. .
Source: Statistics In Medicine, 2021-06-07 00:00:00.0; , .
EPub date: 2021-06-07 00:00:00.0.
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EMBRACE: An EM-based bias reduction approach through Copas-model estimation for quantifying the evidence of selective publishing in network meta-analysis.
Authors: Marks-Anglin A. , Luo C. , Piao J. , Gibbons M.B.C. , Schmid C.H. , Ning J. , Chen Y. .
Source: Biometrics, 2021-02-09 00:00:00.0; , .
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Mediation model with a categorical exposure and a censored mediator with application to a genetic study.
Authors: Wang J. , Ning J. , Shete S. .
Source: Plos One, 2021; 16(10), p. e0257628.
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PMID: 34637449
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Analyzing left-truncated and right-censored infectious disease cohort data with interval-censored infection onset.
Authors: Pak D. , Liu J. , Ning J. , Gómez G. , Shen Y. .
Source: Statistics In Medicine, 2020-10-21 00:00:00.0; , .
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Combining primary cohort data with external aggregate information without assuming comparability.
Authors: Chen Z. , Ning J. , Shen Y. , Qin J. .
Source: Biometrics, 2020-08-21 00:00:00.0; , .
EPub date: 2020-08-21 00:00:00.0.
PMID: 32827153
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CoxPhLb: An R Package for Analyzing Length Biased Data under Cox Model.
Authors: Lee C.H. , Zhou H. , Ning J. , Liu D.D. , Shen Y. .
Source: The R Journal, 2020 Jun; 12(1), p. 118-130.
PMID: 33133648
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Semiparametric modelling and estimation of covariate-adjusted dependence between bivariate recurrent events.
Authors: Ning J. , Cai C. , Chen Y. , Huang X. , Wang M.C. .
Source: Biometrics, 2020-01-28 00:00:00.0; , .
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Penetrance Estimates Over Time to First and Second Primary Cancer Diagnosis in Families with Li-Fraumeni Syndrome: A Single Institution Perspective.
Authors: Shin S.J. , Dodd-Eaton E.B. , Gao F. , Bojadzieva J. , Chen J. , Kong X. , Amos C.I. , Ning J. , Strong L.C. , Wang W. .
Source: Cancer Research, 2020-01-15 00:00:00.0; 80(2), p. 347-353.
EPub date: 2019-11-12 00:00:00.0.
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Semiparametric isotonic regression analysis for risk assessment under nested case-control and case-cohort designs.
Authors: Li W. , Li R. , Feng Z. , Ning J. .
Source: Statistical Methods In Medical Research, 2019-12-22 00:00:00.0; , p. 962280219893389.
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Two-sample test for correlated data under outcome-dependent sampling with an application to self-reported weight loss data.
Authors: Cai Y. , Huang J. , Ning J. , Lee M.T. , Rosner B. , Chen Y. .
Source: Statistics In Medicine, 2019-09-05 00:00:00.0; , .
EPub date: 2019-09-05 00:00:00.0.
PMID: 31489699
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Regression analysis of longitudinal data with outcome-dependent sampling and informative censoring.
Authors: Shen W. , Liu S. , Chen Y. , Ning J. .
Source: Scandinavian Journal Of Statistics, Theory And Applications, 2019 Sep; 46(3), p. 831-847.
EPub date: 2018-12-26 00:00:00.0.
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Analysis of combined incident and prevalent cohort data under a proportional mean residual life model.
Authors: Lee C.H. , Ning J. , Kryscio R.J. , Shen Y. .
Source: Statistics In Medicine, 2019-05-30 00:00:00.0; 38(12), p. 2103-2114.
EPub date: 2019-01-24 00:00:00.0.
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Estimation of the distribution of longitudinal biomarker trajectories prior to disease progression.
Authors: Huang X. , Liu L. , Ning J. , Li L. , Shen Y. .
Source: Statistics In Medicine, 2019-05-20 00:00:00.0; 38(11), p. 2030-2046.
EPub date: 2019-01-06 00:00:00.0.
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A flexible and robust method for assessing conditional association and conditional concordance.
Authors: Liu X. , Ning J. , Cheng Y. , Huang X. , Li R. .
Source: Statistics In Medicine, 2019-05-09 00:00:00.0; , .
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Semiparametric Model for Bivariate Survival Data Subject to Biased Sampling.
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Comparative efficacy of adjuvant trastuzumab-containing chemotherapies for patients with early HER2-positive primary breast cancer: a network meta-analysis.
Authors: Shen Y. , Fujii T. , Ueno N.T. , Tripathy D. , Fu N. , Zhou H. , Ning J. , Xiao L. .
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The impact of Ki-67 in the context of multidisciplinary care in primary inflammatory breast cancer.
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Mediation analysis in a case-control study when the mediator is a censored variable.
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Copas-like selection model to correct publication bias in systematic review of diagnostic test studies.
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Efficient two-stage designs and proper inference for animal studies.
Authors: Cai C. , Piao J. , Ning J. , Huang X. .
Source: Statistics In Biosciences, 2018 Apr; 10(1), p. 217-232.
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Model diagnostics for the proportional hazards model with length-biased data.
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Semiparametric model and inference for spontaneous abortion data with a cured proportion and biased sampling.
Authors: Piao J. , Ning J. , Chambers C.D. , Xu R. .
Source: Biostatistics (oxford, England), 2018-01-01 00:00:00.0; 19(1), p. 54-70.
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Analysis of restricted mean survival time for length-biased data.
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Model-free scoring system for risk prediction with application to hepatocellular carcinoma study.
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Maximum likelihood estimation and EM algorithm of Copas-like selection model for publication bias correction.
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Source: Biostatistics (oxford, England), 2017-07-01 00:00:00.0; 18(3), p. 495-504.
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Estimating treatment effects in observational studies with both prevalent and incident cohorts.
Authors: Ning J. , Hong C. , Li L. , Huang X. , Shen Y. .
Source: The Canadian Journal Of Statistics = Revue Canadienne De Statistique, 2017 Jun; 45(2), p. 202-219.
EPub date: 2017-04-13 00:00:00.0.
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Analyzing Semi-competing Risks Data With Missing Cause Of Informative Terminal Event
Authors: Zhou R. , Zhu H. , Bondy M. , Ning J. .
Source: Statistics In Medicine, 2017-02-28 00:00:00.0; 36(5), p. 738-753.
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Semiparametric Density Ratio Modeling Of Survival Data From A Prevalent Cohort
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Source: Biostatistics (oxford, England), 2017 Jan; 18(1), p. 62-75.
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A Response-adaptive Design Of Initial Therapy For Emergency Department Patients With Heart Failure
Authors: Wen S. , Ning J. , Collins S. , Berry D. .
Source: Contemporary Clinical Trials, 2017 Jan; 52, p. 46-53.
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Conditional independence test by generalized Kendall's tau with generalized odds ratio.
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A Bayesian Multi-stage Cost-effectiveness Design For Animal Studies In Stroke Research
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