Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting.

Katie MellorSaskia EddyNicholas PeckhamChristine M BondMichael Joseph CampbellGillian A LancasterLehana ThabaneSandra M EldridgeSusan J DuttonSally Hopewell

Published in: BMJ open (2021)

Many external randomised pilot trial publications did not adequately report or propose prespecified progression criteria to inform whether to proceed to a future definitive randomised controlled trial.

Keyphrases

study protocol
clinical trial
randomized controlled trial
open label
locally advanced
double blind
radiation therapy
placebo controlled
adverse drug
rectal cancer