The curious case of an internal pilot in a multicentre randomised trial-time for a rethink?

Jonathan Alistair Cook, David John Beard, Johanna Rosemary Cook, Graeme Stewart MacLennan

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)
7 Downloads (Pure)


Multicentre randomised trials are complex projects with many operational uncertainties. The embedding of a formal check upon study progress and viability at a pre-specified time point (sometimes referred to as an 'internal pilot') is becoming increasingly common within multicentre pragmatic randomised trials. However, it is worth considering this practice. We argue that most, if not all, multicentre trials have reassessment of the recruitment strategy and study processes whilst the study is running. Additionally, we propose discontinuation of the 'internal/external pilot study' terminology. Instead, we suggest for an alternative taxonomy along with greater recognition of the process of refinement which routinely occurs in trials and transparent reporting of it.

Original languageEnglish
Article number73
JournalPilot & Feasibility Studies
Publication statusPublished - 13 Dec 2016

Bibliographical note

The authors would like to acknowledge helpful discussions on this topic held with various colleagues in connection with a variety of projects.

No funding was received for this work.


  • Randomised trial
  • Pilot study
  • Recruitment
  • Monitoring
  • Multicentre
  • Feasibility


Dive into the research topics of 'The curious case of an internal pilot in a multicentre randomised trial-time for a rethink?'. Together they form a unique fingerprint.

Cite this