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

ABSTRACT:

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. N

SUBMITTER: Franzoi MA 

PROVIDER: S-EPMC9116999 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature