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  1. Book ; Online ; E-Book: Statistical design, monitoring, and analysis of clinical trials

    Shih, Weichung Joe / Aisner, Joseph

    principles and methods

    (Chapman and Hall/CRC biostatistics series)

    2022  

    Author's details Weichung Joe Shih, Joseph Aisner
    Series title Chapman and Hall/CRC biostatistics series
    Keywords Electronic books
    Language English
    Size 1 Online-Ressource (xxiii, 380 Seiten), Diagramme
    Edition Second edition
    Publisher CRC Press, Taylor & Francis Group
    Publishing place Boca Raton ; London ; New York
    Publishing country United States
    Document type Book ; Online ; E-Book
    Remark Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
    HBZ-ID HT021094604
    ISBN 978-1-00-046281-4 ; 978-1-00-317652-7 ; 9780367772444 ; 9781032009599 ; 1-00-046281-1 ; 1-00-317652-6 ; 0367772442 ; 1032009594
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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  2. Article ; Online: Two-stage stratified designs with survival outcomes and adjustment for misclassification in predictive biomarkers.

    Chen, Yanping / Lin, Yong / Lu, Shou-En / Shih, Weichung J / Quan, Hui

    Statistics in medicine

    2024  Volume 43, Issue 10, Page(s) 1883–1904

    Abstract: Biomarker stratified clinical trial designs are versatile tools to assess biomarker clinical utility and address its relationship with clinical endpoints. Due to imperfect assays and/or classification rules, biomarker status is prone to errors. To ... ...

    Abstract Biomarker stratified clinical trial designs are versatile tools to assess biomarker clinical utility and address its relationship with clinical endpoints. Due to imperfect assays and/or classification rules, biomarker status is prone to errors. To account for biomarker misclassification, we consider a two-stage stratified design for survival outcomes with an adjustment for misclassification in predictive biomarkers. Compared to continuous and/or binary outcomes, the test statistics for survival outcomes with an adjustment for biomarker misclassification is much more complicated and needs to take special care. We propose to use the information from the observed biomarker status strata to construct adjusted log-rank statistics for true biomarker status strata. These adjusted log-rank statistics are then used to develop sequential tests for the global (composite) hypothesis and component-wise hypothesis. We discuss the power analysis with the control of the type-I error rate by using the correlations between the adjusted log-rank statistics within and between the design stages. Our method is illustrated with examples of the recent successful development of immunotherapy in nonsmall-cell lung cancer.
    MeSH term(s) Humans ; Biomarkers/analysis ; Carcinoma, Non-Small-Cell Lung ; Lung Neoplasms ; Research Design ; Clinical Trials as Topic
    Chemical Substances Biomarkers
    Language English
    Publishing date 2024-02-26
    Publishing country England
    Document type Journal Article
    ZDB-ID 843037-8
    ISSN 1097-0258 ; 0277-6715
    ISSN (online) 1097-0258
    ISSN 0277-6715
    DOI 10.1002/sim.10048
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  3. Article ; Online: Editor's Note: Activator Protein-1 Transcription Factors Are Associated with Progression and Recurrence of Prostate Cancer.

    Ouyang, Xuesong / Jessen, Walter J / Al-Ahmadie, Hikmat / Serio, Angel M / Lin, Yong / Shih, Weichung-Joseph / Reuter, Victor E / Scardino, Peter T / Shen, Michael M / Aronow, Bruce J / Vickers, Andrew J / Gerald, William L / Abate-Shen, Cory

    Cancer research

    2023  Volume 83, Issue 7, Page(s) 1161

    Language English
    Publishing date 2023-04-04
    Publishing country United States
    Document type Published Erratum
    ZDB-ID 1432-1
    ISSN 1538-7445 ; 0008-5472
    ISSN (online) 1538-7445
    ISSN 0008-5472
    DOI 10.1158/0008-5472.CAN-23-0515
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  4. Article ; Online: Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis.

    Shih, Weichung J / Yao, Chen / Xie, Tai

    Therapeutic innovation & regulatory science

    2020  Volume 54, Issue 5, Page(s) 1236–1255

    Abstract: Two phase-III, double-blind, randomized clinical trials of remdesivir plus SOC (standard of care) versus placebo plus SOC have been conducted in Wuhan hospitals by Chinese investigators during the urgent COVID-19 epidemic [ClincalTrials.gov NCT04257656 ... ...

    Abstract Two phase-III, double-blind, randomized clinical trials of remdesivir plus SOC (standard of care) versus placebo plus SOC have been conducted in Wuhan hospitals by Chinese investigators during the urgent COVID-19 epidemic [ClincalTrials.gov NCT04257656 and NCT04252664]. These trials have been highly anticipated worldwide. We expect investigators of the trials will soon report the clinical and laboratory findings from the medical perspective. This manuscript provides documentary style information on the process of monitoring key data and making recommendations to the sponsor and investigators based on analytical insights when dealing with the emergent situation from the statistical viewpoint. Having monitored data sequentially from 237 patients, we comment on the strength and weakness of the study design and suggest the treatment effect of remdesivir on severe COVID-19 cases. Our experience with using the Dynamic Data Monitoring (DDM) tool has demonstrated its efficiency and reliability in supporting DSMB's instantaneous review of essential data during the emergent situation. DDM, when used properly by disciplined statisticians, has shown its capability of exploring the trial data flexibly and, in the meantime, protecting the trial's scientific integrity.
    MeSH term(s) Adenosine Monophosphate/adverse effects ; Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/therapeutic use ; Alanine/adverse effects ; Alanine/analogs & derivatives ; Alanine/therapeutic use ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Betacoronavirus/drug effects ; Betacoronavirus/pathogenicity ; China ; Clinical Trials Data Monitoring Committees ; Clinical Trials, Phase III as Topic ; Coronavirus Infections/diagnosis ; Coronavirus Infections/drug therapy ; Coronavirus Infections/virology ; Data Accuracy ; Host Microbial Interactions ; Humans ; Pandemics ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/virology ; Randomized Controlled Trials as Topic ; Research Design ; Time Factors ; Treatment Outcome
    Chemical Substances Antiviral Agents ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
    Keywords covid19
    Language English
    Publishing date 2020-05-16
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2708397-4
    ISSN 2168-4804 ; 2168-4790
    ISSN (online) 2168-4804
    ISSN 2168-4790
    DOI 10.1007/s43441-020-00159-7
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  5. Article ; Online: Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis

    Shih, Weichung J. / Yao, Chen / Xie, Tai

    Therapeutic Innovation & Regulatory Science

    2020  Volume 54, Issue 5, Page(s) 1236–1255

    Keywords Public Health, Environmental and Occupational Health ; Pharmacology (medical) ; Pharmacology, Toxicology and Pharmaceutics (miscellaneous) ; covid19
    Language English
    Publisher Springer Science and Business Media LLC
    Publishing country us
    Document type Article ; Online
    ZDB-ID 2708397-4
    ISSN 2168-4804 ; 2168-4790
    ISSN (online) 2168-4804
    ISSN 2168-4790
    DOI 10.1007/s43441-020-00159-7
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  6. Article ; Online: Remdesivir is Effective for Moderately Severe Patients

    Shih, Weichung J / Shen, Xin / Zhang, Peng / Xie, Tai

    A Re-Analysis of the First Double-Blind, Placebo-Controlled, Randomized Trial on Remdesivir for Treatment of Severe COVID-19 Patients Conducted in Wuhan City

    2020  

    Abstract: Weichung J Shih,1 Xin Shen,2 Peng Zhang,2 Tai Xie2 1Rutgers University School of Public Health ... Piscataway, NJ 08854, USA; 2CIMS Global, Somerset, NJ 08873, USACorrespondence: Weichung J Shih Email shihwj ...

    Abstract Weichung J Shih,1 Xin Shen,2 Peng Zhang,2 Tai Xie2 1Rutgers University School of Public Health, Piscataway, NJ 08854, USA; 2CIMS Global, Somerset, NJ 08873, USACorrespondence: Weichung J Shih Email shihwj@sph.rutgers.eduIntroduction: The first clinical trial on remdesivir for treatment of severe COVID-19 conducted in China was terminated prematurely due to limited patient enrollment, which rendered the findings inconclusive. We re-analyzed the efficacy with a statistically more powerful and clinically meaningful method based on published data using the 6-point ordinal scale of patient’s disease severity.Methods: We defined response as patient’s point reached, either 2 (hospitalized, no requirement for supplementary oxygen therapy) or 1 (discharged or met discharge criterion), and then analyzed with logistic regression with baseline score, day of assessment, treatment group, baseline by treatment interaction, and day by treatment interaction as covariates. The binary endpoint was supported by the recent FDA’s guidance on COVID-19.Results: Eighty-two percent (82%) of the patients were in the disease severity point=3 (hospitalized, required supplemental oxygen (but not NIV/HFNC)) – the moderately severe category. The response rate was 85% for remdesivir-treated patients with baseline disease point=3 versus 70% response rate for likewise placebo-treated patients on Day 28 (OR=2.38, P=0.0012). On Day 14, the response rate for these patients was 43% for remdesivir versus 33% for placebo (OR=1.53, P=0.0022). For patients with baseline disease point=4 (critically severe category), no similar comparisons were statistically significant.Conclusion and Discussion: The Chinese trial was not really under-powered as previously perceived or portrayed by many opinions. This result supports the preliminary findings of ACTT that remdesivir is effective for patients who were not critically severe. This result also suggests that remdesivir should be given to hospitalized COVID-19 patients as soon as possible. There is no race difference in the treatment effect.Keywords: COVID-19, novel coronavirus, remdesivir
    Keywords Open Access Journal of Clinical Trials ; covid19
    Subject code 610
    Language English
    Publishing date 2020-07-30
    Publisher Dove Press
    Publishing country us
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: On study designs and hypotheses for clinical trials with predictive biomarkers.

    Shih, Weichung J / Lin, Yong

    Contemporary clinical trials

    2017  Volume 62, Page(s) 140–145

    Abstract: Recent interest in conducting clinical trials with predictive biomarkers has generated research in comparing relative efficiency of different trial designs. We find these comparisons of efficiency mostly misleading since they are based on different ... ...

    Abstract Recent interest in conducting clinical trials with predictive biomarkers has generated research in comparing relative efficiency of different trial designs. We find these comparisons of efficiency mostly misleading since they are based on different hypotheses. In this paper, we discuss several commonly used trial designs and consider the hypotheses that each design is capable to address. We first consider the ideal situation of no classification errors, then the more realistic situation where marker assay's sensitivity, specificity and the rule of classification are imperfect. We pay special attention to the differences between treatment utility versus absolute treatment effect, and marker by treatment interaction versus marker utility.
    MeSH term(s) Biomarkers ; Humans ; Precision Medicine/methods ; Precision Medicine/standards ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/standards ; Research Design ; Sensitivity and Specificity
    Chemical Substances Biomarkers
    Language English
    Publishing date 2017-08-31
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2182176-8
    ISSN 1559-2030 ; 1551-7144
    ISSN (online) 1559-2030
    ISSN 1551-7144
    DOI 10.1016/j.cct.2017.08.014
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  8. Article ; Online: Two-stage enrichment clinical trial design with adjustment for misclassification in predictive biomarkers.

    Lin, Yong / Shih, Weichung J / Lu, Shou-En

    Statistics in medicine

    2019  Volume 38, Issue 29, Page(s) 5445–5469

    Abstract: A two-stage enrichment design is a type of adaptive design, which extends a stratified design with a futility analysis on the marker negative cohort at the first stage, and the second stage can be either a targeted design with only the marker positive ... ...

    Abstract A two-stage enrichment design is a type of adaptive design, which extends a stratified design with a futility analysis on the marker negative cohort at the first stage, and the second stage can be either a targeted design with only the marker positive stratum, or still the stratified design with both marker strata, depending on the result of the interim futility analysis. In this paper, we consider the situation where the marker assay and the classification rule are possibly subject to error. We derive the sequential tests for the global hypothesis as well as the component tests for the overall cohort and the marker-positive cohort. We discuss the power analysis with the control of the type I error rate and show the adverse impact of the misclassification on the powers. We also show the enhanced power of the two-stage enrichment over the one-stage design and illustrate with examples of the recent successful development of immunotherapy in non-small-cell lung cancer.
    MeSH term(s) Adaptive Clinical Trials as Topic/classification ; Adaptive Clinical Trials as Topic/methods ; Adaptive Clinical Trials as Topic/statistics & numerical data ; Antineoplastic Agents, Immunological/therapeutic use ; Biomarkers/analysis ; Biostatistics ; Carcinoma, Non-Small-Cell Lung/therapy ; Cohort Studies ; Humans ; Immunotherapy ; Lung Neoplasms/therapy ; Models, Statistical ; Progression-Free Survival ; Sample Size
    Chemical Substances Antineoplastic Agents, Immunological ; Biomarkers
    Language English
    Publishing date 2019-10-17
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 843037-8
    ISSN 1097-0258 ; 0277-6715
    ISSN (online) 1097-0258
    ISSN 0277-6715
    DOI 10.1002/sim.8370
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  9. Article ; Online: Ertugliflozin, renoprotection and potential confounding by muscle wasting. Reply to Groothof D, Post A, Gans ROB et al [letter].

    Cherney, David Z I / Charbonnel, Bernard / Cosentino, Francesco / Dagogo-Jack, Samuel / McGuire, Darren K / Pratley, Richard / Shih, Weichung J / Frederich, Robert / Maldonado, Mario / Pong, Annpey / Cannon, Christopher P

    Diabetologia

    2022  Volume 65, Issue 5, Page(s) 908–911

    MeSH term(s) Bridged Bicyclo Compounds, Heterocyclic ; Diabetes Mellitus, Type 2 ; Humans ; Hypoglycemic Agents ; Muscles ; Sodium-Glucose Transporter 2 Inhibitors/therapeutic use
    Chemical Substances Bridged Bicyclo Compounds, Heterocyclic ; Hypoglycemic Agents ; Sodium-Glucose Transporter 2 Inhibitors ; ertugliflozin (6C282481IP)
    Language English
    Publishing date 2022-03-03
    Publishing country Germany
    Document type Letter ; Research Support, Non-U.S. Gov't ; Comment
    ZDB-ID 1694-9
    ISSN 1432-0428 ; 0012-186X
    ISSN (online) 1432-0428
    ISSN 0012-186X
    DOI 10.1007/s00125-021-05623-z
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  10. Article ; Online: Remdesivir is Effective for Moderately Severe Patients

    Shih, Weichung J / Shen, Xin / Zhang, Peng / Xie, Tai

    Open Access Journal of Clinical Trials

    A Re-Analysis of the First Double-Blind, Placebo-Controlled, Randomized Trial on Remdesivir for Treatment of Severe COVID-19 Patients Conducted in Wuhan City

    2020  Volume Volume 12, Page(s) 15–21

    Keywords Pharmacology (medical) ; Pharmacology, Toxicology and Pharmaceutics (miscellaneous) ; covid19
    Language English
    Publisher Informa UK Limited
    Publishing country uk
    Document type Article ; Online
    ZDB-ID 2520705-2
    ISSN 1179-1519
    ISSN 1179-1519
    DOI 10.2147/oajct.s262606
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