Methodological review of the design, objectives and sample size of Research for Patient Benefit (RfPB) applications that use an external randomised controlled pilot trial design: A protocol

Claire L.  Chan; Saskia  Eddy; Jennie Hejdenberg; Ben  Morgan; Heather Morgan; Gillian A Lancaster; Claire Robinson; Sandra  Eldridge

doi:10.1371/journal.pone.0343981

Methodological review of the design, objectives and sample size of Research for Patient Benefit (RfPB) applications that use an external randomised controlled pilot trial design: A protocol

Claire L. Chan^* (Corresponding Author)
, Saskia Eddy
, Jennie Hejdenberg
, Ben Morgan
, Heather Morgan^* (Corresponding Author)
, Gillian A Lancaster
, Claire Robinson
, Sandra Eldridge

^*Corresponding author for this work

Queen Mary University of London
National Institute for Health and Care Research
Keele University

Research output: Contribution to journal › Article › peer-review

Abstract

Background
The National Institute for Health and Care Research accepts applications for pilot and feasibility studies to their Research for Patient Benefit (RfPB) programme. There has been limited work describing the design practices of these applications and funding status. Knowing some of the qualities which may contribute towards a pilot or feasibility study application successfully gaining funding could help researchers improve the quality of their applications. Therefore, this study describes the protocol for a review looking at the characteristics of funded and non-funded external pilot trial applications. In particular, the primary objective is to describe the planned sample size and sample size justifications.

Methods
The study will be conducted on 100 applications from Competition 31–37 with a randomised feasibility design, identified and given access to us by RfPB where the lead applicant has consented. We will screen these applications to identify the external pilot trials, first looking through the titles and then the full text. Following this, we will extract data on information such as medical area, study design, objective(s), sample size, sample size justification, and funding outcome stage one and two. Validation will be performed on 20% of the data extracted; discrepancies will be resolved by discussion or a third reviewer will decide if there is no consensus. We will use descriptive statistics to summarise quantitative data, and will analyse qualitative data using thematic analysis. Findings will be summarised through discussion with the project contributors to produce a reader-friendly guidance document.

Discussion
This work will provide a more complete picture of RfPB external randomised pilot and feasibility trials. The findings will assist researchers when planning their pilot trials, and could help improve the quality of submitted applications.

Protocol Registration
Open Science Framework protocol registration DOI: https://doi.org/10.17605/OSF.IO/PYKVG

Original language	English
Article number	e0343981
Number of pages	11
Journal	PloS ONE
Volume	21
Issue number	3
DOIs	https://doi.org/10.1371/journal.pone.0343981
Publication status	Published - 3 Mar 2026

Data Availability Statement

It is not possible to share the funding applications publicly due to the confidential nature of the data. A Data Sharing Agreement was produced prior to this study which specified that the funding applications cannot be shared, in order to maintain anonymity of the researchers who gave permission for their funding applications to be included in this study. The Secretary of State for Health and Social Care is acknowledged as the source of the data. We accessed the funding applications from NIHR Central Commissioning Facility ([email protected]). Once the data extraction described in this protocol is complete, we plan to share a portion of our data extraction form at the end of the project upon requests to the QMUL PCTU Data Sharing Committee ([email protected]). This will include a random ID number alongside coded versions of items 4, 6, 7, 8, 9, 12, 13, 14, 15, 16, and 17 from Table 1.

Funding

SEd received a Doctor of Philosophy studentship from Queen Mary University of London (QMUL), funded by Barts Charity [MGU0531]. SEd received training from the Medical Research Council - National Institute for Health and Care Research Trials Methodology Research Partnership for her PhD. CC is employed by QMUL who received funding from Asthma UK Centre for Applied Research (AUKCAR) towards this work. AUKCAR is funded by Asthma + Lung UK and the award number is AUK-AC-2018-01. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Funders	Funder number
Queen Mary University of London	MGU0531
Asthma + Lung UK	AUK-AC-2018-01

Access to Document

10.1371/journal.pone.0343981Licence: CC BY

Chan_etal_PLOSO_Methodological_Review_of_VOR
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited https://creativecommons.org/licenses/by/4.0/
Final published version, 431 KBLicence: CC BY

Cite this

Chan, C. L., Eddy, S., Hejdenberg, J., Morgan, B., Morgan, H., Lancaster, G. A., Robinson, C., & Eldridge, S. (2026). Methodological review of the design, objectives and sample size of Research for Patient Benefit (RfPB) applications that use an external randomised controlled pilot trial design: A protocol. PloS ONE, 21(3), Article e0343981. https://doi.org/10.1371/journal.pone.0343981

Methodological review of the design, objectives and sample size of Research for Patient Benefit (RfPB) applications that use an external randomised controlled pilot trial design: A protocol. / Chan, Claire L. (Corresponding Author); Eddy, Saskia ; Hejdenberg, Jennie et al.
In: PloS ONE, Vol. 21, No. 3, e0343981, 03.03.2026.

Research output: Contribution to journal › Article › peer-review

Chan, CL, Eddy, S, Hejdenberg, J, Morgan, B, Morgan, H, Lancaster, GA, Robinson, C & Eldridge, S 2026, 'Methodological review of the design, objectives and sample size of Research for Patient Benefit (RfPB) applications that use an external randomised controlled pilot trial design: A protocol', PloS ONE, vol. 21, no. 3, e0343981. https://doi.org/10.1371/journal.pone.0343981

@article{21ab099be7e747fc8d90993c7096f198,

title = "Methodological review of the design, objectives and sample size of Research for Patient Benefit (RfPB) applications that use an external randomised controlled pilot trial design: A protocol",

abstract = "Background The National Institute for Health and Care Research accepts applications for pilot and feasibility studies to their Research for Patient Benefit (RfPB) programme. There has been limited work describing the design practices of these applications and funding status. Knowing some of the qualities which may contribute towards a pilot or feasibility study application successfully gaining funding could help researchers improve the quality of their applications. Therefore, this study describes the protocol for a review looking at the characteristics of funded and non-funded external pilot trial applications. In particular, the primary objective is to describe the planned sample size and sample size justifications. Methods The study will be conducted on 100 applications from Competition 31–37 with a randomised feasibility design, identified and given access to us by RfPB where the lead applicant has consented. We will screen these applications to identify the external pilot trials, first looking through the titles and then the full text. Following this, we will extract data on information such as medical area, study design, objective(s), sample size, sample size justification, and funding outcome stage one and two. Validation will be performed on 20\% of the data extracted; discrepancies will be resolved by discussion or a third reviewer will decide if there is no consensus. We will use descriptive statistics to summarise quantitative data, and will analyse qualitative data using thematic analysis. Findings will be summarised through discussion with the project contributors to produce a reader-friendly guidance document. Discussion This work will provide a more complete picture of RfPB external randomised pilot and feasibility trials. The findings will assist researchers when planning their pilot trials, and could help improve the quality of submitted applications. Protocol Registration Open Science Framework protocol registration DOI: https://doi.org/10.17605/OSF.IO/PYKVG",

author = "Chan, \{Claire L.\} and Saskia Eddy and Jennie Hejdenberg and Ben Morgan and Heather Morgan and Lancaster, \{Gillian A\} and Claire Robinson and Sandra Eldridge",

year = "2026",

month = mar,

day = "3",

doi = "10.1371/journal.pone.0343981",

language = "English",

volume = "21",

journal = "PloS ONE",

issn = "1932-6203",

publisher = "Public Library of Science",

number = "3",

}

TY - JOUR

T1 - Methodological review of the design, objectives and sample size of Research for Patient Benefit (RfPB) applications that use an external randomised controlled pilot trial design

T2 - A protocol

AU - Chan, Claire L.

AU - Eddy, Saskia

AU - Hejdenberg, Jennie

AU - Morgan, Ben

AU - Morgan, Heather

AU - Lancaster, Gillian A

AU - Robinson, Claire

AU - Eldridge, Sandra

PY - 2026/3/3

Y1 - 2026/3/3

N2 - Background The National Institute for Health and Care Research accepts applications for pilot and feasibility studies to their Research for Patient Benefit (RfPB) programme. There has been limited work describing the design practices of these applications and funding status. Knowing some of the qualities which may contribute towards a pilot or feasibility study application successfully gaining funding could help researchers improve the quality of their applications. Therefore, this study describes the protocol for a review looking at the characteristics of funded and non-funded external pilot trial applications. In particular, the primary objective is to describe the planned sample size and sample size justifications. Methods The study will be conducted on 100 applications from Competition 31–37 with a randomised feasibility design, identified and given access to us by RfPB where the lead applicant has consented. We will screen these applications to identify the external pilot trials, first looking through the titles and then the full text. Following this, we will extract data on information such as medical area, study design, objective(s), sample size, sample size justification, and funding outcome stage one and two. Validation will be performed on 20% of the data extracted; discrepancies will be resolved by discussion or a third reviewer will decide if there is no consensus. We will use descriptive statistics to summarise quantitative data, and will analyse qualitative data using thematic analysis. Findings will be summarised through discussion with the project contributors to produce a reader-friendly guidance document. Discussion This work will provide a more complete picture of RfPB external randomised pilot and feasibility trials. The findings will assist researchers when planning their pilot trials, and could help improve the quality of submitted applications. Protocol Registration Open Science Framework protocol registration DOI: https://doi.org/10.17605/OSF.IO/PYKVG

AB - Background The National Institute for Health and Care Research accepts applications for pilot and feasibility studies to their Research for Patient Benefit (RfPB) programme. There has been limited work describing the design practices of these applications and funding status. Knowing some of the qualities which may contribute towards a pilot or feasibility study application successfully gaining funding could help researchers improve the quality of their applications. Therefore, this study describes the protocol for a review looking at the characteristics of funded and non-funded external pilot trial applications. In particular, the primary objective is to describe the planned sample size and sample size justifications. Methods The study will be conducted on 100 applications from Competition 31–37 with a randomised feasibility design, identified and given access to us by RfPB where the lead applicant has consented. We will screen these applications to identify the external pilot trials, first looking through the titles and then the full text. Following this, we will extract data on information such as medical area, study design, objective(s), sample size, sample size justification, and funding outcome stage one and two. Validation will be performed on 20% of the data extracted; discrepancies will be resolved by discussion or a third reviewer will decide if there is no consensus. We will use descriptive statistics to summarise quantitative data, and will analyse qualitative data using thematic analysis. Findings will be summarised through discussion with the project contributors to produce a reader-friendly guidance document. Discussion This work will provide a more complete picture of RfPB external randomised pilot and feasibility trials. The findings will assist researchers when planning their pilot trials, and could help improve the quality of submitted applications. Protocol Registration Open Science Framework protocol registration DOI: https://doi.org/10.17605/OSF.IO/PYKVG

U2 - 10.1371/journal.pone.0343981

DO - 10.1371/journal.pone.0343981

M3 - Article

SN - 1932-6203

VL - 21

JO - PloS ONE

JF - PloS ONE

IS - 3

M1 - e0343981

ER -

Methodological review of the design, objectives and sample size of Research for Patient Benefit (RfPB) applications that use an external randomised controlled pilot trial design: A protocol

Abstract

Data Availability Statement

Funding

Access to Document

Fingerprint

Cite this