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Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial

BACKGROUND: 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...

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Autores principales: Franzoi, Maria Alice, Procter, Marion, Twelves, Chris, Ponde, Noam, Eiger, Daniel, Emond, Orianne, Clark, Emma, Parlier, Damien, Guillaume, Sébastien, Reaby, Linda, de Azambuja, Evandro, Bines, Jose
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cancer Intelligence 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9116999/
https://www.ncbi.nlm.nih.gov/pubmed/35702414
http://dx.doi.org/10.3332/ecancer.2022.1379
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author Franzoi, Maria Alice
Procter, Marion
Twelves, Chris
Ponde, Noam
Eiger, Daniel
Emond, Orianne
Clark, Emma
Parlier, Damien
Guillaume, Sébastien
Reaby, Linda
de Azambuja, Evandro
Bines, Jose
author_facet Franzoi, Maria Alice
Procter, Marion
Twelves, Chris
Ponde, Noam
Eiger, Daniel
Emond, Orianne
Clark, Emma
Parlier, Damien
Guillaume, Sébastien
Reaby, Linda
de Azambuja, Evandro
Bines, Jose
author_sort Franzoi, Maria Alice
collection PubMed
description BACKGROUND: 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: 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: 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 (p = 0.47), although there was a trend to longer time to RAA in upper middle-income economies (p = 0.07). Except for time from first to last patient randomised, there was wide variation in timelines overall and within geographical regions and economic income groups. CONCLUSIONS: 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.
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spelling pubmed-91169992022-06-13 Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial Franzoi, Maria Alice Procter, Marion Twelves, Chris Ponde, Noam Eiger, Daniel Emond, Orianne Clark, Emma Parlier, Damien Guillaume, Sébastien Reaby, Linda de Azambuja, Evandro Bines, Jose Ecancermedicalscience Research BACKGROUND: 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: 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: 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 (p = 0.47), although there was a trend to longer time to RAA in upper middle-income economies (p = 0.07). Except for time from first to last patient randomised, there was wide variation in timelines overall and within geographical regions and economic income groups. CONCLUSIONS: 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. Cancer Intelligence 2022-04-29 /pmc/articles/PMC9116999/ /pubmed/35702414 http://dx.doi.org/10.3332/ecancer.2022.1379 Text en © the authors; licensee ecancermedicalscience. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
Franzoi, Maria Alice
Procter, Marion
Twelves, Chris
Ponde, Noam
Eiger, Daniel
Emond, Orianne
Clark, Emma
Parlier, Damien
Guillaume, Sébastien
Reaby, Linda
de Azambuja, Evandro
Bines, Jose
Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial
title Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial
title_full Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial
title_fullStr Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial
title_full_unstemmed Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial
title_short Timelines to initiate a phase III trial across the globe: a sub-analysis of the APHINITY trial
title_sort timelines to initiate a phase iii trial across the globe: a sub-analysis of the aphinity trial
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9116999/
https://www.ncbi.nlm.nih.gov/pubmed/35702414
http://dx.doi.org/10.3332/ecancer.2022.1379
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