Trial Closure

This section contains the following:

Introduction
Things to consider
Illustrative example - the Magpie trial
Additional resources

Introduction

Early Termination

If for any reason a trial is terminated early or temporarily suspended the chief investigator should inform the appropriate regulatory authorities and the sponsor. They need to be made aware of why the study was terminated and if any participants are still receiving treatment your plan for their management. All investigators need to be informed immediately and clear reasons given for termination or suspension.

Planned Closure

The end of a trial date should always have been specified in the protocol. A letter from the chief investigator or trial manager should inform all investigators of trial closure. Each local investigator is responsible for informing local staff that the trial is closed.

Things to consider

Complete Human Resources requirements with staff employed for the trial
Put procedures in place for closure on capital items such as buildings, equipment and vehicles

Illustrative example - Magpie trial (audio)

Anticonvulsants are used for pre-eclampsia in the belief they prevent eclamptic convulsions, and so improve outcome. The Magpie trial (the full text is available from the Lancet website) recruited women in 33 countries to either magnesium sulphate (n=5071) or placebo (n=5070). Primary outcomes were eclampsia and, for women randomised before delivery, death of the baby. Follow up was until discharge from hospital after delivery. The trial was stopped early because of benefit. Lelia Duley, University of Leeds, UK, and the principal scientist for the trial, talks about what happened when this happened. Can't see video controller? Play it in your media player.

Additional resources

Stopping a trial early

Picture of Lelia Duley Lelia Duley, University of Leeds, UK, explains why a trial might be closed early (MP4, 32 seconds). Can't see the audio controller? Play it in your media player.

What are the immediate consequences of early trial closure and how should those working on the trial be told about the closure ? (MP4, 2 minutes 41 seconds) Can't see the audio controller? Play it in your media player.

What are the key things to think about with regard to early closure of a trial? (MP4, 41 seconds). Can't see the audio controller? Play it in your media player.

Informing investigators checklist

Checklist of what to include in a letter to investigators on trial closure. This has been contributed by Barbara Farrell who prepared it for the third version of the Trial Management Guide.