Guidance to optimise pilot study design and conduct: a joint HTMR and NIHR HTA 'research on research' proposal


To provide clear guidance for trialists to inform the selection and design of pilot work prior to a definitive/main randomised controlled trial assessing the effect of an intervention, and to provide guidance for selection of progression in RCTs with an internal pilot design.


There are a growing number of studies described as pilot or feasibility studies by their authors.. Research has indicated that many of these pilot and feasibility studies are poorly designed, conducted, and reported. This builds on a programme of work that Pat Hoddinott collaborated on including the development of a CONSORT extension guideline, and work on the role of qualitative research in these studies. In addition, Pat Hoddinott is an associate editor of the new BMC journal, “Pilot and Feasibility Studies”, which is becoming established. There are several key unanswered questions in this field. In particular there has been no work focusing on when researchers should use internal or external pilot study design, and when qualitative research or non-randomised work is required before a main trial. Also, for studies with an internal pilot phase little is known about the selection and reporting of key progression criteria and this is critical to determine main trial success and funding.

NIHR HTA funded internal pilot studies will be analysed to explore their decision making in relation to progression criteria, qualitative interviews will be undertaken and a two-day event will be held in spring 2018.  The first meeting day will consist of presentations by the team and discussion.   Day two will consist of a smaller working group who will together will write guidance on how to optimise pilot study design and how to select an external pilot RCT, internal pilot design and/or non-randomised feasibility work.

Principal Investigator: University of Bristol

NMAHP Research Unit Collaborators: Pat Hoddinott

External Collaborators: Avery K - University of Bristol, Blatch-Jones (nee Young) A - University of Southampton, Bond C - Univeristy of Aberdeen, Coleman C - Queen Mary University London, Duley L - University of Nottingham, Eldridge S - Queen Mary University of London, Gamble C - University of Liverpool, Hopewell S - University of Oxford, Lancaster G - Lancaster University, O'Cathain A - University of Sheffield, Thabane L - McMaster University Ontario, Williamson P - University of Liverpool.

Funder:  Medical Research Council