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Serra, Alessandra ; Mozgunov, Pavel ; Davies, Geraint ; Jaki, Thomas

Determining the minimum duration of treatment in tuberculosis: An order restricted non‐inferiority trial design

Serra, Alessandra , Mozgunov, Pavel, Davies, Geraint und Jaki, Thomas (2023) Determining the minimum duration of treatment in tuberculosis: An order restricted non‐inferiority trial design. Pharmaceutical Statistics 22 (5), S. 938-962.

Veröffentlichungsdatum dieses Volltextes: 18 Mrz 2025 10:05
Artikel
DOI zum Zitieren dieses Dokuments: 10.5283/epub.75773


Zusammenfassung

Tuberculosis (TB) is one of the biggest killers among infectious diseases worldwide. Together with the identification of drugs that can provide benefits to patients, the challenge in TB is also the optimisation of the duration of these treatments. While conventional duration of treatment in TB is 6 months, there is evidence that shorter durations might be as effective but could be associated with ...

Tuberculosis (TB) is one of the biggest killers among infectious diseases worldwide. Together with the identification of drugs that can provide benefits to patients, the challenge in TB is also the optimisation of the duration of these treatments. While conventional duration of treatment in TB is 6 months, there is evidence that shorter durations might be as effective but could be associated with fewer side effects and may be associated with better adherence. Based on a recent proposal of an adaptive order-restricted superiority design that employs the ordering assumptions within various duration of the same drug, we propose a non-inferiority (typically used in TB trials) adaptive design that effectively uses the order assumption. Together with the general construction of the hypothesis testing and expression for type I and type II errors, we focus on how the novel design was proposed for a TB trial concept. We consider a number of practical aspects such as choice of the design parameters, randomisation ratios, and timings of the interim analyses, and how these were discussed with the clinical team.



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Details

DokumentenartArtikel
Titel eines Journals oder einer ZeitschriftPharmaceutical Statistics
Verlag:Wiley
Ort der Veröffentlichung:HOBOKEN
Band:22
Nummer des Zeitschriftenheftes oder des Kapitels:5
Seitenbereich:S. 938-962
Datum6 Juli 2023
InstitutionenInformatik und Data Science > Fachbereich Maschinelles Lernen und Data Science > Chair for Computational Statistics (Prof. Dr. Thomas Jaki)
Identifikationsnummer
WertTyp
10.1002/pst.2320DOI
Stichwörter / KeywordsMOXIFLOXACIN; RIFAPENTINE; REGIMENS; MULTIARM; ISSUES; adaptive designs; infectious diseases; multi-arm multi-stage; non-inferiority; order restriction
Dewey-Dezimal-Klassifikation000 Informatik, Informationswissenschaft, allgemeine Werke > 004 Informatik
600 Technik, Medizin, angewandte Wissenschaften > 615 Pharmazie
StatusVeröffentlicht
BegutachtetJa, diese Version wurde begutachtet
An der Universität Regensburg entstandenZum Teil
URN der UB Regensburgurn:nbn:de:bvb:355-epub-757737
Dokumenten-ID75773

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