Estimands for clinical endpoints in tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial.

Publication Year: 2024

DOI:
10.1186/s13063-024-07999-w

PMCID:
PMC10929173

PMID:
38468320

Journal Information

Full Title: Trials

Abbreviation: Trials

Country: Unknown

Publisher: Unknown

Language: N/A

Publication Details

Subject Category: Therapeutics

Available in Europe PMC: Yes

Available in PMC: Yes

PDF Available: No

Transparency Score
5/6
83.3% Transparent
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Core Indicators
Evidence found in paper:

"availability of data and materials the estimand specification material is available publicly (10 17605/osf io/4a7cq). availability of data and materials the estimand specification material is available publicly (10 17605/osf"

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Evidence found in paper:

"Declarations Ethics approval and consent to participateParticipants in the REMoxTB trial all provided written or witnessed oral informed consent. The ethics committee at University College London and all national and local ethics committees approved the study. The Food and Drug Administration, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), and the national regulatory authorities of the countries in which the trial was conducted reviewed and approved the protocol. Consent for publicationNot applicable. Competing interestsThe authors declare that they have no competing interests. Competing interests The authors declare that they have no competing interests."

Evidence found in paper:

"Funding This work was supported by the Statistical and Data Management Center of the AIDS Clinical Trials Group at Harvard University (National Institute of Allergy and Infectious Diseases UM1-AI068634). This work was supported, in whole or in part, by the Bill & Melinda Gates Foundation (INV-002039). Under the grant conditions of the Foundation, a Creative Commons Attribution 4.0 Generic License has already been assigned to the Author Accepted Manuscript version that might arise from this submission."

Evidence found in paper:

"Trial registration ClinicalTrials.gov NCT00864383. Registered on March 2009"

Open Access
Paper is freely available to read
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Last Updated: Aug 05, 2025