Toward standardization in bladder cancer clinical trials: Guidance from the SITC-IBCG expert panel

Toward standardization in bladder cancer clinical trials: Guidance from the SITC-IBCG expert panel

[...]significant effort was placed on developing a standardized nomenclature to classify BCG failures and recurrences, to permit meaningful comparisons among patients and treatment outcomes.1 The therapeutic landscape of NMIBC began to shift after the US Food and Drug Administration (FDA) issued gui...

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Bibliographic Details
Published in:Journal for immunotherapy of cancer Vol. 12; no. 2; p. e008508
Main Authors: Myers, Amanda A, Kamat, Ashish M, Kilbert, Angela, Galsky, Matthew D
Format: Journal Article
Language:English
Published: England BMJ Publishing Group Ltd 02-02-2024
BMJ Publishing Group LTD
BMJ Publishing Group
Subjects:
Bladder cancer
Cancer therapies
Clinical trials
Clinical Trials as Topic
Collaboration
Commentary
Design
FDA approval
Guidelines as Topic
Humans
Immunotherapy
Medical research
Patients
Reference Standards
Regulatory approval
Standardization
Urinary Bladder Neoplasms
Urinary Bladder Neoplasms - drug therapy
United States > US
Guidelines as Topic
Clinical Trials as Topic
Urinary Bladder Neoplasms
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Summary:[...]significant effort was placed on developing a standardized nomenclature to classify BCG failures and recurrences, to permit meaningful comparisons among patients and treatment outcomes.1 The therapeutic landscape of NMIBC began to shift after the US Food and Drug Administration (FDA) issued guidance in 2018 that provided a much-needed framework for the design of clinical trials, referencing the sentinel publication by the International Bladder Cancer Group (IBCG) in 2016.1–3 This guidance engendered more uniform clinical trials, aiming to define a clear pathway for regulatory approval. Within this document, the expert panel also proposes primary and secondary endpoints and critical values for effect size or response rate thresholds to aid in sample size calculations. [...]standardization results in more comparable and robust datasets suitable for meta-analysis and reduces redundancy across trials.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:2051-1426
2051-1426
DOI:10.1136/jitc-2023-008508