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  1. Article ; Online: Power Considerations in Designing and Interpreting Adaptive Clinical Trials.

    Wang, Rui / Mehta, Cyrus

    NEJM evidence

    2023  Volume 3, Issue 1, Page(s) EVIDe2300309

    Abstract: Adaptive clinical trials allow researchers to make preplanned modifications based on accumulating data from an ongoing trial while preserving the trial's integrity and validity. These modifications may include early termination in cases of successes or ... ...

    Abstract Adaptive clinical trials allow researchers to make preplanned modifications based on accumulating data from an ongoing trial while preserving the trial's integrity and validity. These modifications may include early termination in cases of successes or lack of efficacy, refining the sample size, altering treatments or doses, or focusing recruitment efforts on individuals most likely to benefit. In this issue of
    MeSH term(s) Humans ; Aspirin/therapeutic use ; Risk Factors ; Stroke/drug therapy ; Adaptive Clinical Trials as Topic
    Chemical Substances Aspirin (R16CO5Y76E)
    Language English
    Publishing date 2023-12-26
    Publishing country United States
    Document type Editorial
    ISSN 2766-5526
    ISSN (online) 2766-5526
    DOI 10.1056/EVIDe2300309
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  2. Article ; Online: Commentary on Freidlin and Korn.

    Mehta, Cyrus

    Clinical trials (London, England)

    2017  Volume 14, Issue 6, Page(s) 605–608

    MeSH term(s) Research Design ; Sample Size
    Language English
    Publishing date 2017-08-04
    Publishing country England
    Document type Journal Article ; Comment
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/1740774517724747
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  3. Article ; Online: Optimal adaptive promising zone designs.

    Mehta, Cyrus / Bhingare, Apurva / Liu, Lingyun / Senchaudhuri, Pralay

    Statistics in medicine

    2022  Volume 41, Issue 11, Page(s) 1950–1970

    Abstract: We develop optimal decision rules for sample size re-estimation in two-stage adaptive group sequential clinical trials. It is usual for the initial sample size specification of such trials to be adequate to detect a realistic treatment ... ...

    Abstract We develop optimal decision rules for sample size re-estimation in two-stage adaptive group sequential clinical trials. It is usual for the initial sample size specification of such trials to be adequate to detect a realistic treatment effect
    MeSH term(s) Bayes Theorem ; Humans ; Research Design ; Sample Size
    Language English
    Publishing date 2022-02-14
    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.9339
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  4. Article ; Online: Comments on "Some Challenges with Statistical Inference in Adaptive Designs" by Hung, Wang, and Yang.

    Mehta, Cyrus R

    Journal of biopharmaceutical statistics

    2016  Volume 26, Issue 2, Page(s) 402–404

    MeSH term(s) Clinical Trials as Topic/statistics & numerical data ; Humans ; Models, Statistical ; Research Design
    Language English
    Publishing date 2016
    Publishing country England
    Document type Comment ; Journal Article
    ZDB-ID 1131763-2
    ISSN 1520-5711 ; 1054-3406
    ISSN (online) 1520-5711
    ISSN 1054-3406
    DOI 10.1080/10543406.2015.1099541
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  5. Article ; Online: A simulation-based comparison of estimation methods for adaptive and classical group sequential clinical trials.

    Nelson, Bryan S / Liu, Lingyun / Mehta, Cyrus

    Pharmaceutical statistics

    2021  Volume 21, Issue 3, Page(s) 599–611

    Abstract: Statistical methods for controlling the type-I error of hypothesis tests in adaptive group sequential clinical trials are well established and well understood. However, methods for obtaining statistically valid point estimates and confidence intervals ... ...

    Abstract Statistical methods for controlling the type-I error of hypothesis tests in adaptive group sequential clinical trials are well established and well understood. However, methods for obtaining statistically valid point estimates and confidence intervals for adaptive designs are not as well established or as well understood. At the end of an adaptive trial, one may calculate the repeated confidence interval (RCI), which provides conservative coverage of
    MeSH term(s) Bias ; Computer Simulation ; Humans ; Research Design ; Sample Size
    Language English
    Publishing date 2021-12-26
    Publishing country England
    Document type Journal Article
    ZDB-ID 2083706-9
    ISSN 1539-1612 ; 1539-1604
    ISSN (online) 1539-1612
    ISSN 1539-1604
    DOI 10.1002/pst.2188
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  6. Article ; Online: Adaptive clinical trial designs with pre-specified rules for modifying the sample size: a different perspective.

    Mehta, Cyrus R

    Statistics in medicine

    2013  Volume 32, Issue 8, Page(s) 1276–1279

    MeSH term(s) Data Interpretation, Statistical ; Humans ; Randomized Controlled Trials as Topic/methods ; Sample Size
    Language English
    Publishing date 2013-04-15
    Publishing country England
    Document type Comment ; Journal Article
    ZDB-ID 843037-8
    ISSN 1097-0258 ; 0277-6715
    ISSN (online) 1097-0258
    ISSN 0277-6715
    DOI 10.1002/sim.5720
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  7. Article ; Online: Adaptive multiarm multistage clinical trials.

    Ghosh, Pranab / Liu, Lingyun / Mehta, Cyrus

    Statistics in medicine

    2020  Volume 39, Issue 8, Page(s) 1084–1102

    Abstract: Two methods for designing adaptive multiarm multistage (MAMS) clinical trials, originating from conceptually different group sequential frameworks are presented, and their operating characteristics are compared. In both methods pairwise comparisons are ... ...

    Abstract Two methods for designing adaptive multiarm multistage (MAMS) clinical trials, originating from conceptually different group sequential frameworks are presented, and their operating characteristics are compared. In both methods pairwise comparisons are made, stage-by-stage, between each treatment arm and a common control arm with the goal of identifying active treatments and dropping inactive ones. At any stage one may alter the future course of the trial through adaptive changes to the prespecified decision rules for treatment selection and sample size reestimation, and notwithstanding such changes, both methods guarantee strong control of the family-wise error rate. The stage-wise MAMS approach was historically the first to be developed and remains the standard method for designing inferentially seamless phase 2-3 clinical trials. In this approach, at each stage, the data from each treatment comparison are summarized by a single multiplicity adjusted P-value. These stage-wise P-values are combined by a prespecified combination function and the resultant test statistic is monitored with respect to the classical two-arm group sequential efficacy boundaries. The cumulative MAMS approach is a more recent development in which a separate test statistic is constructed for each treatment comparison from the cumulative data at each stage. These statistics are then monitored with respect to multiplicity adjusted group sequential efficacy boundaries. We compared the powers of the two methods for designs with two and three active treatment arms, under commonly utilized decision rules for treatment selection, sample size reestimation and early stopping. In our investigations, which were carried out over a reasonably exhaustive exploration of the parameter space, the cumulative MAMS designs were more powerful than the stage-wise MAMS designs, except for the homogeneous case of equal treatment effects, where a small power advantage was discernable for the stage-wise MAMS designs.
    MeSH term(s) Research Design ; Sample Size
    Language English
    Publishing date 2020-02-11
    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.8464
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  8. Article ; Online: Smartphone goniometer has excellent reliability between novice and experienced physical therapists in assessing knee range of motion.

    Mehta, Saurabh P / Bremer, Hans / Cyrus, Hannah / Milligan, Ashely / Oliashirazi, Ali

    Journal of bodywork and movement therapies

    2020  Volume 25, Page(s) 67–74

    Abstract: Introduction: Smartphone app-based goniometer (SG) are emerging as an alternative to Universal Goniometers (UG) in assessing joint range of motion (ROM). This study examined whether the experience level of examiner affected the reliability of assessing ... ...

    Abstract Introduction: Smartphone app-based goniometer (SG) are emerging as an alternative to Universal Goniometers (UG) in assessing joint range of motion (ROM). This study examined whether the experience level of examiner affected the reliability of assessing knee flexion (KF) and knee extension (KE) ROM using UG and SG.
    Methods: Participants with osteoarthritis of the knee or following total knee replacement were recruited. KF and KE ROM using UG and SG were assessed twice by an experienced physical therapist (PT) and a student PT (SPT). Intraclass correlation coefficients (ICC) examined the interrater (experienced PT vs SPT) and intrarater reliabilities (for experienced PT and SPT) in assessing KF and KE ROM for UG and SG. Concurrent relationships were examined between the knee ROM with pain and physical function using Pearson Correlation Coefficient (r).
    Results: The interrater reliability in assessing KF and KE ROM was excellent (ICC>0.90) between novice and experienced examiners. The standard error of measurement (SEM) for novice examiner in assessing KF was 1° and 2° while using UG and SG respectively; whereas the SEM for experienced examiner in assessing KF was 1° irrespective of which device was used. The concurrent relationships between KF and KE ROM with measures of pain and function were divergent (moderate to low correlations; r <0.7; p > 0.05).
    Conclusion: Both UG and SG have smaller measurement error in assessing KF and KE ROM irrespective of experience level of examiner and therefore no one tool is superior than the other for assessing knee ROM in clinical practice.
    MeSH term(s) Arthrometry, Articular ; Humans ; Physical Therapists ; Range of Motion, Articular ; Reproducibility of Results ; Smartphone
    Language English
    Publishing date 2020-11-16
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2029441-4
    ISSN 1532-9283 ; 1360-8592
    ISSN (online) 1532-9283
    ISSN 1360-8592
    DOI 10.1016/j.jbmt.2020.11.021
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  9. Article ; Online: Adaptive Designs for Clinical Trials.

    Bhatt, Deepak L / Mehta, Cyrus

    The New England journal of medicine

    2016  Volume 375, Issue 1, Page(s) 65–74

    MeSH term(s) Biomarkers ; Clinical Trials as Topic/methods ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Government Regulation ; Humans ; Research Design ; Sample Size
    Chemical Substances Biomarkers
    Language English
    Publishing date 2016-07-07
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMra1510061
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  10. Article ; Online: External validation and extension of the TIMI risk score for heart failure in diabetes for patients with recent acute coronary syndrome: An analysis of the EXAMINE trial.

    Razaghizad, Amir / Sharma, Abhinav / Ni, Jiayi / Ferreira, João Pedro / White, William B / Mehta, Cyrus R / Bakris, George L / Zannad, Faiez

    Diabetes, obesity & metabolism

    2022  Volume 25, Issue 1, Page(s) 229–237

    Abstract: Aims: The Thrombolysis in Myocardial Infarction Risk Score for Heart Failure (HF) in Diabetes (TRS-HF: Materials and methods: The TRS-HF: Results: In total, HF hospitalization occurred in 193 (3.6%) patients. Based on the TRS-HF: Conclusion: ... ...

    Abstract Aims: The Thrombolysis in Myocardial Infarction Risk Score for Heart Failure (HF) in Diabetes (TRS-HF
    Materials and methods: The TRS-HF
    Results: In total, HF hospitalization occurred in 193 (3.6%) patients. Based on the TRS-HF
    Conclusion: The TRS-HF
    MeSH term(s) Humans ; Acute Coronary Syndrome/complications ; Acute Coronary Syndrome/diagnosis ; Acute Coronary Syndrome/epidemiology ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/epidemiology ; Risk Factors ; Heart Failure/complications ; Heart Failure/epidemiology
    Language English
    Publishing date 2022-09-29
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1454944-x
    ISSN 1463-1326 ; 1462-8902
    ISSN (online) 1463-1326
    ISSN 1462-8902
    DOI 10.1111/dom.14867
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