Patient and public involvement and engagement in the ASCEND PLUS trial: reflections from the design of a streamlined and decentralised clinical trial.

Muram El-NayirRohan S WijesurendraDavid PreissMarion MafhamLeandros TsiotosSadman IslamAnne WhitehouseSophia WilkinsonHannah FreemanRyonfa LeeWojciech BrudloGenna BobbyBryony JenkinsRobert HumphreyAmy MallorieAndrew ToalElnora C BarkerDianna MoylanGraeme ThomsonFiroza DaviesHameed KhanIan AlloteySusan DickieJohn Roberts

Published in: Trials (2024)

PPIE is integral in ASCEND PLUS and will continue throughout the trial. This involvement has been critical to optimising the trial design, successfully obtaining regulatory and ethical approval, and conducting the trial.

Keyphrases

clinical trial
phase iii
study protocol
phase ii
open label
randomized controlled trial
healthcare
mental health
double blind
case report
placebo controlled