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Statistics in Biopharmaceutical Research

Statistics in Biopharmaceutical Research

中文名称：生物制药研究统计

ISSN：1946-6315
出版周期：

发文量：144

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1.Analysis of Matched Studies With Dichotomous Outcomes Using Nonparametric Randomization-Based Analysis of Covariance
- 作者：Hussey Michael A.;Koch Gary G.;Preisser John S.Saville Benjamin R.
- 期刊名称：《statistics in biopharmaceutical research》 | 2013年第3期
- Binary outcome;
- Clinical trial;
- Matching;
- Nonparametric methods;
- Weighted least squares;
2.A General Framework for Treatment Effect Estimators Considering Patient Adherence
- 作者：Qu Yongming;Fu Haoda;Luo JunxiangRuberg Stephen J.
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第1期
3.A New Bayesian Dose-Finding Design for Drug Combination Trials
- 作者：Mu Rongji;Xu Jin
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第4期
- Adaptive modeling;
- Dose finding;
- Drug combination;
- Sequential design;
- I CLINICAL-TRIALS;
- COPULA REGRESSION;
- OVERDOSE CONTROL;
- 2 AGENTS;
- ONCOLOGY;
- ESCALATION;
- MODEL;
4.Regulatory Experience of Qualifying Total Kidney Volume as a Prognostic Biomarker for Clinical Trial Enrichment
- 作者：Lawrence John;Wang Sue-Jane;Hung H. M. James
- 期刊名称：《statistics in biopharmaceutical research》 | 2019年第3期
- Biomarker;
- Chronic kidney disease;
- Enrichment;
5.A Conditional t Suite of Tests for Identifying Differentially Expressed Genes in a DNA Microarray Experiment with Little Replication
- 作者：Amaratunga Dhammika;Cabrera Javier
- 期刊名称：《statistics in biopharmaceutical research》 | 2009年第1期
- Borrowing strength;
- Ct;
- Critical curve;
- Resampling;
- SAM;
- t test;
- Target estimation;
- Wedge effect;
6.Estimating the Treatment Effect in a Subgroup Defined by an Early Post-Baseline Biomarker Measurement in Randomized Clinical Trials With Time-To-Event Endpoint
- 作者：Bornkamp Bjoern;Bermann Georgina
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第1期
- Causal inference;
- Estimand;
- Principal stratification;
- Subgroup analysis;
- Weighting;
- CAUSAL INFERENCE;
- ASSUMPTION;
- SURVIVAL;
7.Meta-Analysis of Clinical Trials With Sparse Binary Outcomes Using Zero-Inflated Binomial (ZIB) Models
- 作者：Dong Cheng;Zhao Yueqin;Tiwari Ram
- 期刊名称：《statistics in biopharmaceutical research》 | 2019年第3期
- EM algorithm;
- Fixed-effects model;
- Rare events;
- 2 X-2 TABLES;
- MYOCARDIAL-INFARCTION;
- ROSIGLITAZONE;
- REGRESSION;
- POISSON;
- RISK;
8.Notes on Interval Estimation Under the AB/BA Design in Multicenter Trials With Binary Responses
- 作者：Lui Kung-Jong;Lin Chii-Dean
- 期刊名称：《statistics in biopharmaceutical research》 | 2019年第3期
- Conditional likelihood;
- Coverage probability;
- Exact interval estimator;
- Mantel-Haenszel method;
- Weighted-least-squares;
9.Optimal Interim Decision Rules Based on a Binary Surrogate Outcome for Adaptive Biomarker-Based Trials in Oncology
- 作者：Krisam Johannes;Kieser Meinhard
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第4期
10.Design and Analysis of Diabetes Prevention Trials for Glucose-Lowering Drugs
- 作者：Holzhauer Bjoern
- 期刊名称：《statistics in biopharmaceutical research》 | 2014年第1期
11.Family-Wise Error Rate Controlling Procedures for Discrete Data
- 作者：Zhu Yalin;Guo Wenge
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第1期
- CDF of p-values;
- Clinical safety study;
- Multiple testing;
- Step-wise procedure;
- FALSE DISCOVERY RATE;
- MULTIPLE TESTS;
- POWER;
12.Contributions of Robert T. O'Neill to the Evolution of Regulatory Statistical Science
- 作者：Anello Charles;Junod Suzanne
- 期刊名称：《statistics in biopharmaceutical research》 | 2013年第3期
- Adequate and well controlled studies;
- BEMAC;
- Clinical trials;
- DESI;
- ICH;
- Safety evaluation;
- CLINICAL-TRIALS;
- SAMPLE SIZES;
- HYPOTHESIS;
- APPROVAL;
- ISSUES;
- DRUGS;
13.Equivalence Test for Two Emax Response Curves
- 作者：Jin Bo;Barker Kerry B.
- 期刊名称：《statistics in biopharmaceutical research》 | 2016年第3期
- Biosimilarity;
- Emax model;
- Equivalence;
- DRUG DEVELOPMENT;
- METAANALYSIS;
14.Beginning of an Educational Avalanche in Medicine Development and Regulation
- 作者：Buehler Fritz
- 期刊名称：《statistics in biopharmaceutical research》 | 2013年第3期
15.Being Efficient About Efficacy Estimation
- 作者：Senn Stephen
- 期刊名称：《statistics in biopharmaceutical research》 | 2013年第3期
- Analysis of covariance;
- Flexible designs;
- Responder analysis;
- Patient-by-treatment interaction;
- Pharmacogentics;
- Dichotomies;
- CLINICAL-TRIALS;
- DESIGNS;
- STATISTICIANS;
- WORKING;
16.The Effects of Herd Immunity on the Power of Vaccine Trials
- 作者：Charvat Blake;Brookmeyer Ron;Herson Jay
- 期刊名称：《statistics in biopharmaceutical research》 | 2009年第1期
- Clinical trial;
- Power;
- Simulation;
- EFFICACY;
- MODEL;
17.Identifying a Subpopulation for a Tailored Therapy: Bridging Clinical Efficacy From a Laboratory-Developed Assay to a Validated In Vitro Diagnostic Test Kit
- 作者：Denne Jonathan S.;Pennello Gene;Zhao LupingChang Shao-ChunAlthouse Sandra
- 期刊名称：《statistics in biopharmaceutical research》 | 2014年第1期
- Agreement;
- Companion diagnostic;
- Concordance;
- Oncology;
- Pharmacogenomics;
- Predictive biomarker;
- MISSING DATA;
- TRIALS;
- CHALLENGES;
- IMPUTATION;
18.Multivariate Shared-Parameter Mixed-Effects Location Scale Model for Analysis of Intensive Longitudinal Data
- 作者：Lin Xiaolei;Xun Xiaolei
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第2期
- Intensive longitudinal data;
- Missing data;
- Mixed-effects model;
- INTRAINDIVIDUAL VARIABILITY;
- MISSING DATA;
- ISSUES;
19.Confidence Intervals of Interaction Index for Assessing Multiple Drug Interaction
- 作者：Lee J. Jack;Kong Maiying
- 期刊名称：《statistics in biopharmaceutical research》 | 2009年第1期
- Antagonism;
- Loewe additivity model;
- Synergy;
20.Statistical Considerations for Cardiovascular Outcome Trials in Patients with Type. Diabetes Mellitus
- 作者：Marchenko Olga;Jiang Qi;Chuang-Stein ChristyMehta CyrusLevenson MarkRussek-Cohen EstelleLiu LingyunSanchez-Kam MatildeZink RichardKe ChunleiMa HaijunMaca JeffPark Soomin
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第4期
- Cardiovascular risk;
- CVOT;
- Diabetes mellitus;
- Event window;
- Missing data;
- Multiplicity;
- Subgroup analysis;
- CLINICAL-TRIALS;
- SUBGROUP ANALYSIS;
- SAFETY;
- CONSISTENCY;
- RISK;
- DRUG;
21.Univariate Versus Multivariate Surrogates in the Single-Trial Setting
- 作者：Van der Elst Wim;Alonso Ariel Abad;Geys HelenaMeyvisch PaulBijnens LucSengupta RudradevMolenberghs Geert
- 期刊名称：《statistics in biopharmaceutical research》 | 2019年第3期
- Causal inference;
- Information theory;
- Multivariate surrogate endpoints;
- END-POINTS;
- CAUSAL-INFERENCE;
- METAANALYTIC PARADIGMS;
- CLINICAL-TRIALS;
- VALIDATION;
- STATISTICS;
22.Statistical Methods for Selecting Maximum Effective Dose and Evaluating Treatment Effect When Dose-Response is Monotonic
- 作者：Kong Maiying;Rai Shesh N.;Bolli Roberto
- 期刊名称：《statistics in biopharmaceutical research》 | 2014年第1期
- O'Brien and Fleming's repeated significance test;
- Two-stage design;
- Williams' test;
- MULTIPLE COMPARISONS;
23.An Adaptive Phase. Trial for Evaluating Two Monoclonal Antibodies and the Combination for Prevention of Recurrence of C. difficile Infection
- 作者：Koury Kenneth J.;Tipping Robert W.
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第4期
- Adaptive design;
- Family-wise error rate;
- Food and Drug Administration;
- Phase III trial;
- CLOSTRIDIUM-DIFFICILE;
- OUTBREAK;
- DISEASE;
24.Methods for Missing Data Handling in Phase III Clinical Trials with Nonnormal Endpoints and Nonnormal Covariates
- 作者：Fan Chunpeng;Wei Lynn;Koch Gary G.
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第1期
- MAR;
- Missing at random;
- Missing not at random;
- MNAR;
- Nonparametric;
- Rank;
25.AICc for Calibration Model Selection in Assay Validation
- 作者：Zhang Lanju;Tan Charles;LeBlond David
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第4期
- AICc;
- Akaike weight;
- Assay procedure;
- Bayesian;
- Calibration model;
- Linearity test;
- Power;
- Type I error rate;
26.Adjusting for Unknown Bias in Noninferiority Clinical Trials
- 作者：Odem-Davis Katherine;Fleming Thomas R.
- 期刊名称：《statistics in biopharmaceutical research》 | 2013年第3期
- Active control;
- Constancy;
- Delta;
- Equivalence;
- Margin;
- NON-INFERIORITY TRIALS;
- DESIGN;
27.Semiparametric Regression Modeling of Incomplete Longitudinal Outcomes: Stratifying on Informative Missingness Predictors
- 作者：Javaras Kristin N.;Fitzmaurice Garrett M.
- 期刊名称：《statistics in biopharmaceutical research》 | 2009年第1期
- Informative covariates;
- Missing outcomes;
- Missingness mechanism;
- Generalized estimating equations;
- Marginal models;
28.The Evaluation of Proof-of-Concept Trial Design for Compound Selection
- 作者：Lu Jiandong;Dong Bin
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第4期
29.Statistics in Biopharmaceutical Research Best Papers Award
- 作者：Hamasaki Toshimitsu;Bretz Frank
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第2期
30.Comparison of Isotonic Designs for Dose-Finding
- 作者：Ivanova Anastasia;Flournoy Nancy
- 期刊名称：《statistics in biopharmaceutical research》 | 2009年第1期
- Isotonic estimate;
- Phase I trial;
- Up-and-down designs;
- PHASE-I TRIALS;
31.Model Averaging Using Likelihoods That Reflect Poor Outcomes for Clinical Trial Dropouts
- 作者：Liu G. Frank;Liu Fang;Mehrotra Devan V.
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第1期
- Dropout;
- Model averaging;
- Quantile regression;
- Trimmed means;
- MISSING DATA;
- ESTIMANDS;
- MIXTURE;
- POINTS;
32.Sensitivity Analysis for Withdrawals in Grouped Time-to-Event Data
- 作者：Zhao Yue;Preisser John S.;Koch Gary G.
- 期刊名称：《statistics in biopharmaceutical research》 | 2014年第1期
33.Estimands in a Chronic Pain Trial: Challenges and Opportunities
- 作者：Callegari Francesca;Akacha Mouna;Quarg PeterPandhi Shaloovon Raison FlorianZuber Emmanuel
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第1期
- Chronic pain;
- Estimand;
- ICH E9 (R1) guideline;
- Numerical rating scale;
- SENSITIVITY;
34.Causal Inference and Estimands in Clinical Trials
- 作者：Lipkovich Ilya;Ratitch Bohdana;Mallinckrodt Craig H.
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第1期
- Causal inference;
- Estimands;
- Intercurrent events;
- Potential outcomes;
- PROPENSITY-SCORE;
- PRINCIPAL STRATIFICATION;
- RANDOMIZED EXPERIMENTS;
- BAYESIAN-INFERENCE;
- MISSING DATA;
- SURVIVAL;
- OUTCOMES;
- DURATION;
35.Divergence Effect Analysis in Disease-Modifying Trials
- 作者：Li Jianjun (David);Barlas Suna
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第4期
- Delayed-start trial;
- Disease-modifying treatment;
- Divergence effect;
- Slope analysis;
- PARKINSONS-DISEASE;
- ALZHEIMER-DISEASE;
- DELAYED-START;
- DESIGN;
36.Extended Rank Tests for Analyzing Recurrent Event Data
- 作者：Zhao Qiang;Zhang Bin;LaValley Michael P.Massaro Joseph M.Lunetta Kathryn L.Chang Mark
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第1期
- Bias;
- Informative number of events;
- Intra-subject correlation;
- Rank tests;
- Recurrent events;
- FAILURE TIME DATA;
- REGRESSION-ANALYSIS;
- NONPARAMETRIC-ESTIMATION;
- MODEL;
37.A New Principal Stratum Estimand Investigating the Treatment Effect in Patients Who Would Comply, If Treated With a Specific Treatment
- 作者：Larsen Klaus Groes;Josiassen Mette Krog
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第1期
- Adherence;
- Causal inference;
- Compliance;
- ICH E9 (R1);
- Principal stratification;
- CAUSAL INFERENCE;
- IDENTIFICATION;
- MEDIATION;
38.On Identifying Minimum Efficacious Doses in Combination Drug Trials
- 作者：Soulakova Julia N.;Sampson Allan R.
- 期刊名称：《statistics in biopharmaceutical research》 | 2009年第1期
- Average test;
- Closed testing;
- Dose-response;
- Minimum effective dose;
- Step-down procedure;
39.A Bayesian Framework Allowing Incorporation of Retrospective Information in Prospective Diagnostic Biomarker-Validation Designs
- 作者：Barrado Leandro Garcia;Coart Els;Burzykowski Tomasz
- 期刊名称：《statistics in biopharmaceutical research》 | 2019年第3期
40.Regression Analysis of Fold-Increase Endpoints Using a Distributional Approach for Paired Interval-Censored Antibody Data
- 作者：Cheung Yin Bun;Ma Xiangmei;Lam K. F.
- 期刊名称：《statistics in biopharmaceutical research》 | 2019年第3期
- Antibody titers;
- Covariate adjustment;
- Dichotomization;
- Distributional approach;
- Interval-censoring;
- Risk ratio;
- RISK-FACTORS;
- OBESITY;
- OUTCOMES;
- MODELS;
41.Nonproportional Hazards and the Power of Sequential Trials
- 作者：Jiang Qi;Snapinn Steven
- 期刊名称：《statistics in biopharmaceutical research》 | 2009年第1期
- Clinical trial simulation;
- Data monitoring;
- Futility;
- Lag;
- Noncompliance;
42.Current Practices, Challenges, and Statistical Issues With Product Safety Labeling
- 作者：Crowe Brenda;Brueckner Andreas;Beasley CharlesKulkarni Pandurang
- 期刊名称：《statistics in biopharmaceutical research》 | 2013年第3期
- Adverse reaction;
- Causation;
- Core data sheet;
- Summary of product characteristics;
- United States package insert;
- ADVERSE EVENTS;
43.Incorporating Biomarkers to Improve Statistical Power of Immunotherapeutic Neoadjuvant Clinical Trials in Patients with Triple-Negative Breast Cancer
- 作者：Gao Feng;Wang Guoqiao;Luo JingqinLiu JingxiaChen LingXiong Chengjie
- 期刊名称：《statistics in biopharmaceutical research》 | 2019年第3期
44.Homogeneity Test of Ratio of Two Proportions in Stratified Bilateral Data
- 作者：Zhuang Tingting;Tian Guo-Liang;Ma Chang-Xing
- 期刊名称：《statistics in biopharmaceutical research》 | 2019年第3期
45.Do Covariates Change the Estimand?
- 作者：Permutt Thomas
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第1期
- Causal inference;
- Clinical trials;
- Double robust;
- CLINICAL-TRIALS;
46.Two-Stage Sample Size Reassessment Using Perturbed Unblinding
- 作者：Shih Weichung Joe
- 期刊名称：《statistics in biopharmaceutical research》 | 2009年第1期
- Adaptive designs;
- Double-blind clinical trials;
- ICH;
- Sample size re-estimation;
- ADAPTIVE DESIGNS;
- REESTIMATION;
- VARIANCE;
- TRIALS;
47.A General AUC-Type Measure and Biomarker Selection
- 作者：Wang Zhanfeng;Chang Yuan-Chin Ivan
- 期刊名称：《statistics in biopharmaceutical research》 | 2014年第1期
- Area under curve;
- Classification;
- Continuous gold standard;
- ROC curve;
- GOLD STANDARD;
- ACCURACY;
48.Statistical Issues and Controversies in Active-Controlled, 'Noninferiority' Trials
- 作者：Carroll Kevin J.
- 期刊名称：《statistics in biopharmaceutical research》 | 2013年第3期
- Fixed margin;
- Percent preservation;
- Putative placebo;
- Standard of evidence;
- Synthesis;
- INFERIORITY MORTALITY TRIALS;
- CLINICAL-TRIALS;
- ONCOLOGY;
- DESIGN;
- EFFICACY;
49.On Analysis of Changes in Rates and Averaged Correlated Rates
- 作者：Fan Chunpeng;Kuang Chensheng;Lu XinZhang Mei
- 期刊名称：《statistics in biopharmaceutical research》 | 2019年第3期
- GEE;
- Generalized linear model;
- MMRM;
- Odds ratio;
- Rate difference;
- Rate ratio;
- BINARY RESPONSE DATA;
- ODDS RATIO;
- CONFIDENCE-INTERVALS;
- BINOMIAL REGRESSION;
- RISK;
50.A Quantitative Process for Enhancing End of Phase 2 Decisions
- 作者：Sabin Tony;Matcham James;Bray SarahCopas AndrewParmar Mahesh K. B.
- 期刊名称：《statistics in biopharmaceutical research》 | 2014年第1期
- Decision making;
- Pancreatic cancer;
- Probability of success;
- CLINICAL-TRIAL;
- DRUG DEVELOPMENT;
- SURVIVAL;
51.Noninferiority Trials in Regulatory Guidance and Marketing Authorization Applications: Huge Advances Over the Last 20 Years but Problems Still to be Solved
- 作者：Brown David
- 期刊名称：《statistics in biopharmaceutical research》 | 2013年第3期
- CHMP;
- Clinical trials;
- FDA;
- ICH E9;
- Noninferiority margin;
- Statistics;
52.Group Sequential Design With Change of Endpoint
- 作者：Wang Lulu;Li Qing;Li ZiliangKaur Amarjot
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第4期
- Bonferroni;
- Group sequential tests;
- Logistic model;
- Rheumatoid arthritis;
- CLINICAL-TRIALS;
- RHEUMATOID-ARTHRITIS;
- TESTS;
53.Estimating and Testing the Variation of a Binary Treatment Effect Over Clusters in a Proportional Hazard Frailty Model
- 作者：Feng Shibao;Nie Lei
- 期刊名称：《statistics in biopharmaceutical research》 | 2014年第1期
54.Concepts, Methods, and Practical Considerations of Meta-Analysis in Drug Development
- 作者：Shun Zhenming;Lei Gao;Liu QianyingZheng WeiQuan HuiHitier Simon
- 期刊名称：《statistics in biopharmaceutical research》 | 2016年第3期
- Aflibercept;
- Integrated summaries;
- TREATMENT-RELATED MORTALITY;
- PHASE-II;
- DOUBLE-BLIND;
- OVARIAN-CANCER;
- SAFETY DATA;
- AFLIBERCEPT;
- RECURRENT;
- PLACEBO;
- DOCETAXEL;
- TRIAL;
55.Statistical Considerations for Noninferiority Trial Designs Without Placebo
- 作者：Hung H. M. James;Wang Sue-Jane
- 期刊名称：《statistics in biopharmaceutical research》 | 2013年第3期
- Across-trial;
- As-treated;
- Bayesian;
- Intention-to-treat;
- Likelihood;
- Noninferiority margin;
- On-treatment;
- Perprotocol;
- Synthesis method;
- TEAM WHITE PAPER;
- INTENT-TO-TREAT;
- NON-INFERIORITY;
- CONSISTENT STANDARD;
- ISSUES;
- CHOICE;
- EFFICACY;
- MARGIN;
- DELTA;
- CHALLENGES;
56.Exact Methods for Testing the Equality of Proportions for Binary Clustered Data From Otolaryngologic Studies
- 作者：Shan Guogen;Ma Changxing
- 期刊名称：《statistics in biopharmaceutical research》 | 2014年第1期
- Conditional test;
- E plus M p-value;
- Exact test;
- Otolaryngology;
- Unconditional test;
- UNCONDITIONAL TESTS;
- DETECTING TRENDS;
- MATCHED-PAIRS;
- STATISTICS;
- EFFICIENT;
- RESPONSES;
57.Methods for Using Aggregate Historical Control Data in Meta-Analyses of Clinical Trials With Time-to-Event Endpoints
- 作者：Holzhauer Bjorn
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第1期
58.Methods for Assessing Improvement in Specificity When a Biomarker is Combined With a Standard Screening Test
- 作者：Shaw Pamela A.;Pepe Margaret S.;Alonzo Todd A.Etzioni Ruth
- 期刊名称：《statistics in biopharmaceutical research》 | 2009年第1期
- Diagnostic tests;
- Relative accuracy;
- ROC curve;
- Specificity;
- Study design;
59.Simultaneous Evaluation of the Magnitude and Breadth of a Left- and Right-Censored Multivariate Response, With Application to HIV Vaccine Development
- 作者：Huang Yunda;Gilbert Peter B.;Montefiori David C.Self Steve G.
- 期刊名称：《statistics in biopharmaceutical research》 | 2009年第1期
60.Analysis and Design of Clinical Trials Using Additive Hazards Survival Endpoints
- 作者：McDaniel Lee S.;Yu Menggang;Chappell Rick
- 期刊名称：《statistics in biopharmaceutical research》 | 2019年第3期
- Analysis scale;
- Clinical trials;
- Goodness of fit;
- Margin;
- Noninferiority;
- SAMPLE-SIZE;
- ADJUVANT THERAPY;
- NONINFERIORITY;
- FLUOROURACIL;
- LEVAMISOLE;
- MODEL;
61.Learning From Epidemiology: Interpreting Observational Database Studies for the Effects of Medical Products
- 作者：Ryan Patrick;Suchard Marc A.;Schuemie MartijnMadigan David
- 期刊名称：《statistics in biopharmaceutical research》 | 2013年第3期
- Adverse drug reaction;
- Bayesian analysis;
- Causality;
- Electronic health record;
- Epidemiologic method;
- Pharmacoepidemiology;
- DESIGN;
62.Considerations on Testing Secondary Endpoints in Group Sequential Design
- 作者：Li Xiaoming;Wulfsohn Michael S.;Koch Gary G.
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第4期
- Group sequential;
- Hierarchical testing;
- Interim analysis;
- Primary endpoint;
- Secondary endpoint;
- Type I error;
- CLINICAL-TRIALS;
- BOUNDARIES;
63.A Versatile Adaptive Dose-Finding Design Based on Multiple Endpoints
- 作者：Baayen Corine;Hougaard Philip;Pipper C. B.
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第3期
- Adaptive trial;
- D-optimality;
- Multiple outcomes;
- Penalty function;
- Therapeutic window;
- CONTINUAL REASSESSMENT METHOD;
- CLINICAL-TRIALS;
- EFFICACY;
- TOXICITY;
- SAFETY;
64.Cancer Clinical Trials beyond Pandemic: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion
- 作者：Sridhara Rajeshwari;Barksdale Elizabeth;Marchenko OlgaJiang QiAndo YukiBloomquist ErickCoory MichaelCrouse MelissaDegtyarev EvgenyFramke TheodorFreidlin BorisGerber David E.Gwise ThomasJosephson FilipHess LorenzoKluetz PaulLi DanielMandrekar SumithraPosch MartinRantell KhadijaRatitch BohdanaRaven AndrewRoes KitRufibach KasparSarac Sinan B.Simon RichardSingh HarpreetTheoret MarcThomson AndrewZuber EmmanuelLi Shen YuanPazdur Richard
- 期刊名称：《statistics in biopharmaceutical research》 | 2023年第2期
- COVID-19 pandemic;
- Decentralized trials;
- Oncology drug development;
- Telemedicine;
65.Comment on 'Non-Proportional Hazards - an Evaluation of the MaxCombo Test in Cancer Clinical Trials' by the Cross-Pharma Non-Proportional Hazards Working Group
- 作者：Lin Ray;Mukhopadhyay Pralay;Roychoudhury Satrajit M.Anderson KeavenHu TianleHuang Bo F.Leon LarryLiao Jason J. Z.Lin JiLiu RongLuo XiaodongMai YabingQin RuiTatsuoka KayWang YangYe JiabuZhu JianChen Tai-TsangIacona Renee
- 期刊名称：《statistics in biopharmaceutical research》 | 2023年第2期
66.Evaluation of an Adaptive Seamless Design for a Phase II/III Clinical Trial in Recurrent Events Data to Demonstrate Reduction in Number of Acute Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- 作者：Casula Daniela;Callegaro Andrea;Nakanwagi PhoebeWeynants VincentArora Ashwani Kumar
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第3期
- Fixed design;
- Group sequential design;
- Interim analysis;
- Sample size reassessment;
- Study design;
- Vaccine efficacy;
- SAMPLE-SIZE;
- DOUBLE-BLIND;
- POWER;
67.Penalized Logistic Regression Likelihood Ratio Test Analysis to Detect Signals of Adverse Events From Interactions in Postmarket Safety Surveillance
- 作者：Nam Kijoeng;Henderson Nicholas C.;Rohan PatriciaRussek-Cohen Estelle
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第4期
- Adverse event;
- Signal detection;
- Vaccine safety;
- Vaccine-vaccine interactions;
- FEBRILE SEIZURES;
- RISK;
- VACCINATION;
- PERTUSSIS;
- MEASLES;
- MUMPS;
68.Sample Size Determination for Stratified Phase II Cancer Trials With Monotone Order Constraints
- 作者：Xu Menghao;Ye Ting;Zhao Jun-junYu Menggang
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第4期
69.Statistical Inference Based on Accelerated Failure Time Models Under Model Misspecification and Small Samples
- 作者：Ishii Ryota;Maruo Kazushi;Noma HisashiGosho Masahiko
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第4期
- Bartlett adjustment;
- Bootstrap method;
- Likelihood ratio test;
- Test size;
- PROPORTIONAL HAZARDS;
- BARTLETT ADJUSTMENT;
- LIKELIHOOD;
- REGRESSION;
- ADULTS;
- LIFE;
70.Sample Size Calculation for 'Gold-Standard' Noninferiority Trials With Fixed Margins and Negative Binomial Endpoints
- 作者：Homma Gosuke;Daimon Takashi
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第4期
71.Optimal Designs for Estimating the ED50 When Response Functions Have a Downturn
- 作者：Hyun Seung Won
- 期刊名称：《statistics in biopharmaceutical research》 | 2014年第1期
- c-Optimality;
- Dose Range;
- Experimental Design;
- Peak Dose;
72.Exact Tests for Disease Prevalence Studies With Partially Validated Data
- 作者：Shan Guogen
- 期刊名称：《statistics in biopharmaceutical research》 | 2019年第3期
73.Efficiency Comparison of Analysis Methods for Recurrent Event and Time-to-First Event Endpoints in the Presence of Terminal Events-Application to Clinical Trials in Chronic Heart Failure
- 作者：Fritsch Arno;Schloemer Patrick;Mendolia FrancoMutze TobiasJahn-Eimermacher Antje
- 期刊名称：《statistics in biopharmaceutical research》 | 2023年第2期
74.Assessing Agreement Between Two Methods of Quantitative Measurements: Exact Test Procedure and Sample Size Calculation
- 作者：Shieh Gwowen
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第3期
- Equivalence trials;
- Limits of agreement;
- Method comparison;
- Percentile;
- Tolerance interval;
- EQUIVALENCE TESTS;
- PERFORMANCE;
- HYPOTHESIS;
- LIMITS;
- INDEX;
- RANGE;
75.Target Population Statistical Inference With Data Integration Across Multiple Sources-An Approach to Mitigate Information Shortage in Rare Disease Clinical Trials
- 作者：Li Xihao;Song Yang
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第3期
- Causal inference;
- Historical control;
- Rare disease;
- Real world evidence;
- Statistical learning;
- HISTORICAL CONTROL DATA;
- METAANALYSIS;
76.Rejoinder to Letter to the Editor on 'A New Principal Stratum Estimand Investigating the Treatment Effect in Patients Who Would Comply, If Treated With a Specific Treatment'
- 作者：Larsen Klaus Groes;Josiassen Mette Krog
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第4期
77.A Tolerance Interval Approach to Assessing the Biosimilarity of Follow-On Biologics
- 作者：Chen Chi-Tian;Tsou Hsiao-Hui;Hsiao Chin-FuLai Yi-HsuanChang Wan-JungLiu Jung-Tzu
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第3期
- Biosimilar;
- Biosimilarity index;
- Innovator biologic;
- Probability-based method;
- Tolerance interval;
- HIGHLY VARIABLE DRUGS;
- STATISTICAL ASSESSMENT;
- PRODUCTS;
- VARIABILITY;
- BIOEQUIVALENCE;
- PROBABILITY;
- EFFICACY;
- SAFETY;
- LIMITS;
78.The Strong Null Hypothesis and the MaxCombo Test: Comment on 'Robust Design and Analysis of Clinical Trials with Nonproportional Hazards: A Straw Man Guidance form a Cross-Pharma Working Group.'
- 作者：Magirr Dominic;Burman Carl-Fredrik
- 期刊名称：《statistics in biopharmaceutical research》 | 2023年第2期
79.Current Issues in Analytical Similarity Assessment
- 作者：Chow Shein-Chung;Lee Sang Joon
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第2期
- Equivalence test;
- Extrapolation;
- Flexible margin;
- mQR method;
- QR method;
- Reference product change;
80.Combined Tests Based on Restricted Mean Time Lost for Competing Risks Data
- 作者：Lyu Jingjing;Hou Yawen;Chen Zheng
- 期刊名称：《statistics in biopharmaceutical research》 | 2023年第2期
- Combined test;
- Competing risks;
- Nonproportional subdistribution hazards;
- Restricted mean time lost;
- SURVIVAL-TIME;
- CUMULATIVE INCIDENCE;
- LIFE;
- TRIALS;
81.Editor's Note
- 作者：Hamasaki Toshimitsu
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第4期
82.Bayesian Approaches on Borrowing Historical Data for Vaccine Efficacy Trials
- 作者：Jin Man;Feng Dai;Liu Guanghan
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第3期
- Bayesian approach;
- Beta prior;
- Hierarchical models;
- Power prior;
- Sample size calculations;
- Vaccine efficacy trials;
- POWER PRIOR;
- INFORMATION;
83.An Alternative Implementation of Reference-Based Controlled Imputation Procedures
- 作者：Lu Kaifeng
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第4期
84.Imbalanced Randomization in Vaccine Clinical Safety Trials
- 作者：Patterson Scott;Bailleux Fabrice;Chen JoshZhu Ming
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第3期
- Binary;
- Imbalance;
- Randomization;
- Vaccine;
- SAMPLE-SIZE;
- DIFFERENCE;
- RISK;
85.Comment on 'Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group': The Test Statistic Should Estimate Some Reasonable Measure of Treatment Benefit
- 作者：Snapinn Steven;Jiang Qi;Ke Chunlei
- 期刊名称：《statistics in biopharmaceutical research》 | 2023年第2期
86.Survey and Recommendations on the Use of P-Values Driving Decisions in Nonclinical Pharmaceutical Applications
- 作者：Altan Stan;Amaratunga Dhammika;Cabrera JavierGarren JeoniferGeys HelenaKolassa JohnLeBlond DavidLi DingzhouLiao JasonLiu JiaLubomirski MariuszMiro-Quesada GuillermoNovick StevenOtava MartinPeterson JohnReckermann KatharinaSchofield TimTan CharlesTatikola KanakaTekle FeteneThomas JenniferVukovinsky Kim
- 期刊名称：《statistics in biopharmaceutical research》 | 2023年第2期
- SIMULTANEOUS CONFIDENCE-INTERVALS;
- ICH Q8 DEFINITION;
- DESIGN SPACE;
- COMPUTER EXPERIMENTS;
- TESTS;
- CARCINOGENICITY;
- EQUIVALENCE;
- DISCOVERY;
- SYSTEM;
- SAFETY;
87.Properties of Two While-Alive Estimands for Recurrent Events and Their Potential Estimators
- 作者：Wei Jiawei;Muetze Tobias;Jahn-Eimermacher AntjeRoger James
- 期刊名称：《statistics in biopharmaceutical research》 | 2023年第2期
- Estimand;
- Intercurrent events;
- LWYY;
- Quasi-Poisson;
- SEMIPARAMETRIC REGRESSION;
- HEART-FAILURE;
- TIME;
88.Comment on 'Estimands for Recurrent Event Endpoints in the Presence of a Terminal Event'
- 作者：Hung H. M. James;Wang Sue-Jane
- 期刊名称：《statistics in biopharmaceutical research》 | 2023年第2期
89.Utility-Based Interim Decision Rule Planning in Adaptive Population Selection Designs With Survival Endpoints
- 作者：Uozumi Ryuji;Hamada Chikuma
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第3期
90.Randomization-Based Methods for Treatment Comparisons for Dichotomous Outcomes for Multiple Anatomical Regions
- 作者：Yu Jing;Koch Gary
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第4期
91.Introduction to the 2020 Special Issue on Vaccines and Biologics
- 作者：Altan Stan;Liu Frank
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第3asi期
92.Editor's Note: Special Section on Estimands, Design and Analysis of Clinical Trials with Time-to-Event Outcomes
- 作者：Hamasaki Toshimitsu
- 期刊名称：《statistics in biopharmaceutical research》 | 2023年第2期
93.Noninferiority Clinical Trials With Binary Outcome: Statistical Methods Used in Practice
- 作者：Sidi Yulia;Harel Ofer
- 期刊名称：《statistics in biopharmaceutical research》 | 2021年第4期
- Noninferiority design;
- Replicability;
- Reproducibility;
- Review;
- EQUIVALENCE RANDOMIZED-TRIALS;
- CONFIDENCE-INTERVALS;
- NULL HYPOTHESIS;
- DIFFERENCE;
- PROPORTIONS;
- PREVENTION;
- EXTENSION;
- TESTS;
94.Centered Isotonic Regression: Point and Interval Estimation for Dose-Response Studies
- 作者：Oron Assaf P.;Flournoy Nancy
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第3期
- Binary data analysis;
- Dose-finding;
- Nonparametric regression;
- Nonparametric statistics;
- Small-sample methods;
- Up-and-down;
- DOWN DESIGN;
- PHASE-I;
- CONFIDENCE-INTERVALS;
- QUANTAL BIOASSAY;
- TOXICITY;
- CURVES;
- LIMITS;
95.Notes on Exact Power Calculations for t Tests and Analysis of Covariance
- 作者：Tang Yongqiang
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第3期
- Gold standard noninferiority trial;
- Linear contrast;
- Multi-arm randomized trial;
- Pre-stratification factor;
96.The Choice of a Randomization Procedure in Survival Studies with Nonproportional Hazards
- 作者：Rueckbeil Marcia Viviane;Manolov Martin;Hilgers Ralf-Dieter
- 期刊名称：《statistics in biopharmaceutical research》 | 2023年第2期
- Allocation bias;
- Fleming-Harrington test;
- Log-rank test;
- Max-combo test;
- Selection bias;
- SELECTION BIAS;
- COVARIATE IMBALANCES;
- TEST DECISIONS;
- TRIALS;
- WEIGHTS;
- CURVES;
- SAMPLE;
- IMPACT;
- TESTS;
97.On the Extended Welch Test for Assessing Equivalence of Standardized Means
- 作者：Jan Show-Li;Shieh Gwowen
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第3期
- Equivalence;
- Power;
- Sample size;
- Variance heterogeneity;
- Welch test;
- EFFECT SIZE;
- STATISTICAL SIGNIFICANCE;
- APPROXIMATE DEGREES;
- FREEDOM TESTS;
- HYPOTHESIS;
- VARIANCES;
- INTERPRET;
- POWER;
98.Improved Statistical Methods for Evaluation of Stability of In Vitro Diagnostic Reagents
- 作者：Holland Mark;Kraght Paul;Akbas NevalBudd JeffreyKlee George
- 期刊名称：《statistics in biopharmaceutical research》 | 2017年第3期
- Equivalence testing;
- Regression analysis;
- Stability testing;
99.On Incremental Incidence Rates in Long-Term Cohort Safety Studies
- 作者：Aras Girish;Yang Jingyuan;Shao Yongwu
- 期刊名称：《statistics in biopharmaceutical research》 | 2013年第3期
100.Hierarchical Linear Models for Multiregional Clinical Trials
- 作者：Kim Saemina;Kang Seung-Ho
- 期刊名称：《statistics in biopharmaceutical research》 | 2020年第3期
- Between-cluster variability;
- Mixed effect model;
- Permutation test;
- Random coefficient model;
- SAMPLE-SIZE;
- CONSISTENCY ASSESSMENT;
- JAPANESE PATIENTS;
- DESIGN;
- REGIONS;

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