Shahrul Mt-Isa
Overview
Explore the profile of Shahrul Mt-Isa including associated specialties, affiliations and a list of published articles.
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37
Citations
1367
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Recent Articles
1.
Gorrod H, Mt-Isa S, Xuan J, Vandormael K, Malbecq W, Yorke-Edwards V, et al.
Stat Methods Med Res
. 2025 Jan;
34(2):322-335.
PMID: 39819221
Treatment switching is common in randomised controlled trials (RCTs). Participants may switch onto a variety of different treatments, all of which may have different treatment effects. Adjustment analyses that target...
2.
Xuan J, Mt-Isa S, Latimer N, Gorrod H, Malbecq W, Vandormael K, et al.
Stat Methods Med Res
. 2024 Dec;
34(2):286-306.
PMID: 39668583
Deviation from the treatment strategy under investigation occurs in many clinical trials. We term this intervention deviation. Per-protocol analyses are widely adopted to estimate a hypothetical estimand without the occurrence...
3.
Use of transportability methods for real-world evidence generation: a review of current applications
Levy N, Arena P, Jemielita T, Mt-Isa S, McElwee S, Lenis D, et al.
J Comp Eff Res
. 2024 Oct;
13(11):e240064.
PMID: 39364567
To evaluate how transportability methods are currently used for real-world evidence (RWE) generation to inform good practices and support adoption and acceptance of these methods in the RWE context. We...
4.
Pocock S, Owen R, Gregson J, Mt-Isa S, Baumgartner R, Ashby D, et al.
J Thromb Haemost
. 2024 Jan;
22(5):1399-1409.
PMID: 38280725
Background: A treatment's overall favorable benefit-risk profile does not imply that every individual patient will benefit from the treatment. Objectives: To describe a statistical methodology for quantifying the benefit-risk trade-off...
5.
Mt-Isa S, Chumbley J, Crawford E, Banniettis N, Buchwald U, Weaver J, et al.
Expert Rev Vaccines
. 2023 Oct;
22(1):906-917.
PMID: 37846456
Objectives: Immunogenicity between 15-valent V114 (PCV15) and 20-valent PCV20 pneumococcal conjugate vaccines in healthy infants is compared in an indirect treatment comparison and matching-adjusted indirect comparison. Hypotheses: immunogenicity of V114...
6.
Pinto C, Balantac Z, Mt-Isa S, Liu X, Bracco O, Clarke H, et al.
Drug Discov Today
. 2023 Jul;
28(10):103719.
PMID: 37467877
The European Medicines Agency (EMA) and FDA have policy goals of strengthening benefit-risk (B-R) capabilities; but how this has been translating into regulatory practice is unclear. A systematic review of...
7.
Seifu Y, Mt-Isa S, Duke K, Gamalo-Siebers M, Wang W, Dong G, et al.
J Biopharm Stat
. 2022 Dec;
33(6):696-707.
PMID: 36545791
A fundamental problem in the regulatory evaluation of a therapy is assessing whether the benefit outweighs the associated risks. This work proposes designing a trial that assesses a composite endpoint...
8.
Mt-Isa S, Abderhalden L, Musey L, Weiss T
Expert Rev Vaccines
. 2021 Oct;
21(1):115-123.
PMID: 34672224
Background: V114 (15-valent pneumococcal conjugate vaccine [PCV15]) and a 20-valent PCV (PCV20) are approved for adults (≥18 years) in the United States. We present methodologies to indirectly compare immune responses...
9.
Golan Y, Tang Y, Mt-Isa S, Wan H, Teal V, Badshah C, et al.
Pharmacoecon Open
. 2021 Apr;
5(3):469-473.
PMID: 33871830
Background: Allogeneic hematopoietic stem cell transplantation (HSCT) is associated with substantial healthcare resource use, particularly when recipients develop cytomegalovirus (CMV) infection. Letermovir reduced post-HSCT CMV infection risk compared with placebo...
10.
Ngo D, Baumgartner R, Mt-Isa S, Feng D, Chen J, Schnell P
PLoS One
. 2020 Feb;
15(2):e0229336.
PMID: 32101562
Due to differential treatment responses of patients to pharmacotherapy, drug development and practice in medicine are concerned with personalized medicine, which includes identifying subgroups of population that exhibit differential treatment...