A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials.

ABSTRACT:

Background

Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of the specification and also the assessment of progression criteria. The aim of the review is to provide an overview of current practice.

Methods

A cohort of clinical trials with an internal pilot, funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (HTA), extracted in 2017 was reviewed. Data were extracted from: project descriptions; summary of changes from the first stage; feedback about the full application; monitoring notes; progress report history and protocols, for information

SUBMITTER: Rosala-Hallas A 

PROVIDER: S-EPMC6751663 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature