Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial.
clinical trials
ethics committee/institutional review board
regulatory approval
trial activation timelines
Journal
Ecancermedicalscience
ISSN: 1754-6605
Titre abrégé: Ecancermedicalscience
Pays: England
ID NLM: 101392236
Informations de publication
Date de publication:
2022
2022
Historique:
received:
07
12
2021
entrez:
15
6
2022
pubmed:
16
6
2022
medline:
16
6
2022
Statut:
epublish
Résumé
Geographic location and national income may influence access to innovation in healthcare. We aimed to study if geographical location and national income influenced the timelines to activate the global phase III APHINITY trial, evaluating adjuvant pertuzumab in patients with HER2-positive early breast cancer. Time from regulatory authority (RA) submission to approval (RAA), time to Ethics Committee/Institutional Review Board (EC/IRB) approval, time from study approval by EC/IRB to first randomised patient and from first to last randomised patient were collected. Analyses were conducted grouping countries by geographical region or economic income classification. Forty-one countries (of 42) had data available regarding all relevant timelines. No statistical difference was observed between the time to RAA and geographical region ( Geographical location and income classification did not appear to be the major drivers influencing time for clinical trial activation. Wide variability in activation timelines within geographical regions and income groups exists and is worthy of further investigation.
Sections du résumé
Background
UNASSIGNED
Geographic location and national income may influence access to innovation in healthcare. We aimed to study if geographical location and national income influenced the timelines to activate the global phase III APHINITY trial, evaluating adjuvant pertuzumab in patients with HER2-positive early breast cancer.
Methods
UNASSIGNED
Time from regulatory authority (RA) submission to approval (RAA), time to Ethics Committee/Institutional Review Board (EC/IRB) approval, time from study approval by EC/IRB to first randomised patient and from first to last randomised patient were collected. Analyses were conducted grouping countries by geographical region or economic income classification.
Results
UNASSIGNED
Forty-one countries (of 42) had data available regarding all relevant timelines. No statistical difference was observed between the time to RAA and geographical region (
Conclusions
UNASSIGNED
Geographical location and income classification did not appear to be the major drivers influencing time for clinical trial activation. Wide variability in activation timelines within geographical regions and income groups exists and is worthy of further investigation.
Identifiants
pubmed: 35702414
doi: 10.3332/ecancer.2022.1379
pii: can-16-1379
pmc: PMC9116999
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1379Informations de copyright
© the authors; licensee ecancermedicalscience.
Déclaration de conflit d'intérêts
MAF, OE, DP, SG and LR: none. CT: Travel grant, Roche; advisory board: AstraZeneca, Eisai, Daiichi Sankyo, MSD. Speaker: Pfizer and Eisai. MP: MP’s institution received funding from Roche in respect of the APHINITY trial. NP: advisory board: Lilly; contracted research: Novartis, AstraZeneca, Daichii Sankyo, Roche and Pfizer; speaker: Novartis, Lilly, AstraZeneca and Roche. DE: funding for his research fellowship (2018–2019): Novartis; speaker fee: Janssen; salary paid by Roche. EA: honoraria and/or advisory board from Roche/GNE, Novartis, Seattle Genetics, Zodiac and Libbs; travel grants from Roche/GNE and GSK/Novartis; research grant to my institution from Roche/GNE, Astra-Zeneca, GSK/Novartis and Servier. JB: travel expenses: AstraZeneca and Roche; consultant: AstraZeneca, Daiichi Sankyo, Genomic Health, Libbs, Lilly MSD, Novartis, Pfizer and Roche. EC: employee of Roche Products Ltd; issued patent: Uses for and article of manufacture including HER2 dimerisation inhibitor pertuzumab, 13/649591.
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