­­­­Using evidence when planning for trial recruitment: An international perspective from time-poor trialists

Heidi Gardner* (Corresponding Author), Shaun Treweek, Katie Gillies

*Corresponding author for this work

Research output: Contribution to journalArticle

Abstract

Introduction
Recruiting participants to trials is challenging. To date, research has focussed on improving recruitment once the trial is underway, rather than planning strategies to support it, e.g. developing trial information leaflets together with people like those to be recruited. We explored whether people involved with participant recruitment have explicit planning strategies; if so, how these are developed, and if not, what prevents effective planning.

Methods
Design: Individual qualitative semi-structured interviews. Data were analysed using a Framework approach, and themes linked through comparison of data within and across stakeholder groups.

Participants: 23 international trialists (UK, Canada, South Africa, Italy, the Netherlands); 11 self-identifying as ‘Designers’; those who design recruitment methods, and 12 self-identifying as ‘Recruiters’; those who recruit participants. Interviewees’ had recruitment experience spanning diverse interventions and clinical areas.

Setting: Primary, secondary and tertiary-care sites involved in trials, academic institutions, and contract research organisations supporting pharmaceutical companies.

Results
To varying degrees, respondents had prospective strategies for recruitment. These were seldom based on rigorous evidence.

When describing their recruitment planning experiences, interviewees identified a range of influences that they believe impacted success:

The timing of recruitment strategy development relative to the trial start date, and who is responsible for recruitment planning.
The methods used to develop trialists’ recruitment strategy design and implementation skills, and when these skills are gained (i.e. before the trial or throughout).
The perceived barriers and facilitators to successful recruitment planning; and how trialists modify practice when recruitment is poor.
Conclusions
Respondents from all countries considered limited time and disproportionate approvals processes as major challenges to recruitment planning. Poor planning is a mistake that trialists live with throughout the trial. The experiences of our participants suggest that effective recruitment requires strategies to increase the time for trial planning, as well as access to easily implementable evidence-based strategies.
Original languageEnglish
Article number0226081
JournalPloS ONE
Volume14
Issue number12
DOIs
Publication statusPublished - 10 Dec 2019

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Internationality
planning
Planning
Secondary Care
Tertiary Healthcare
Contracts
South Africa
Research
Netherlands
Italy
Canada
Organizations
Interviews
Pharmaceutical Preparations
educational institutions
research institutions
stakeholders
Surveys and Questionnaires
interviews

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • General
  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

@article{fe05484ea72b4ca3b1d28fda9a03b595,
title = "­­­­Using evidence when planning for trial recruitment: An international perspective from time-poor trialists",
abstract = "IntroductionRecruiting participants to trials is challenging. To date, research has focussed on improving recruitment once the trial is underway, rather than planning strategies to support it, e.g. developing trial information leaflets together with people like those to be recruited. We explored whether people involved with participant recruitment have explicit planning strategies; if so, how these are developed, and if not, what prevents effective planning.MethodsDesign: Individual qualitative semi-structured interviews. Data were analysed using a Framework approach, and themes linked through comparison of data within and across stakeholder groups.Participants: 23 international trialists (UK, Canada, South Africa, Italy, the Netherlands); 11 self-identifying as ‘Designers’; those who design recruitment methods, and 12 self-identifying as ‘Recruiters’; those who recruit participants. Interviewees’ had recruitment experience spanning diverse interventions and clinical areas.Setting: Primary, secondary and tertiary-care sites involved in trials, academic institutions, and contract research organisations supporting pharmaceutical companies.ResultsTo varying degrees, respondents had prospective strategies for recruitment. These were seldom based on rigorous evidence.When describing their recruitment planning experiences, interviewees identified a range of influences that they believe impacted success:The timing of recruitment strategy development relative to the trial start date, and who is responsible for recruitment planning.The methods used to develop trialists’ recruitment strategy design and implementation skills, and when these skills are gained (i.e. before the trial or throughout).The perceived barriers and facilitators to successful recruitment planning; and how trialists modify practice when recruitment is poor.ConclusionsRespondents from all countries considered limited time and disproportionate approvals processes as major challenges to recruitment planning. Poor planning is a mistake that trialists live with throughout the trial. The experiences of our participants suggest that effective recruitment requires strategies to increase the time for trial planning, as well as access to easily implementable evidence-based strategies.",
author = "Heidi Gardner and Shaun Treweek and Katie Gillies",
note = "Funding: This study was funded by the Chief Scientist Office of Scotland’s Health Improvement, Protection and Services Research Committee (project reference HIPS/16/07 - https://www.cso.scot.nhs.uk/outputs/cso-funded-research/hips16/). HRG was supported by a scholarship from Aberdeen Development Trust which funded her PhD fees and stipend, KG was supported by an MRC Methodology Research Fellowship (MR/L01193X/1), and ST was supported by core funding from the University of Aberdeen. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.",
year = "2019",
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AU - Gardner, Heidi

AU - Treweek, Shaun

AU - Gillies, Katie

N1 - Funding: This study was funded by the Chief Scientist Office of Scotland’s Health Improvement, Protection and Services Research Committee (project reference HIPS/16/07 - https://www.cso.scot.nhs.uk/outputs/cso-funded-research/hips16/). HRG was supported by a scholarship from Aberdeen Development Trust which funded her PhD fees and stipend, KG was supported by an MRC Methodology Research Fellowship (MR/L01193X/1), and ST was supported by core funding from the University of Aberdeen. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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N2 - IntroductionRecruiting participants to trials is challenging. To date, research has focussed on improving recruitment once the trial is underway, rather than planning strategies to support it, e.g. developing trial information leaflets together with people like those to be recruited. We explored whether people involved with participant recruitment have explicit planning strategies; if so, how these are developed, and if not, what prevents effective planning.MethodsDesign: Individual qualitative semi-structured interviews. Data were analysed using a Framework approach, and themes linked through comparison of data within and across stakeholder groups.Participants: 23 international trialists (UK, Canada, South Africa, Italy, the Netherlands); 11 self-identifying as ‘Designers’; those who design recruitment methods, and 12 self-identifying as ‘Recruiters’; those who recruit participants. Interviewees’ had recruitment experience spanning diverse interventions and clinical areas.Setting: Primary, secondary and tertiary-care sites involved in trials, academic institutions, and contract research organisations supporting pharmaceutical companies.ResultsTo varying degrees, respondents had prospective strategies for recruitment. These were seldom based on rigorous evidence.When describing their recruitment planning experiences, interviewees identified a range of influences that they believe impacted success:The timing of recruitment strategy development relative to the trial start date, and who is responsible for recruitment planning.The methods used to develop trialists’ recruitment strategy design and implementation skills, and when these skills are gained (i.e. before the trial or throughout).The perceived barriers and facilitators to successful recruitment planning; and how trialists modify practice when recruitment is poor.ConclusionsRespondents from all countries considered limited time and disproportionate approvals processes as major challenges to recruitment planning. Poor planning is a mistake that trialists live with throughout the trial. The experiences of our participants suggest that effective recruitment requires strategies to increase the time for trial planning, as well as access to easily implementable evidence-based strategies.

AB - IntroductionRecruiting participants to trials is challenging. To date, research has focussed on improving recruitment once the trial is underway, rather than planning strategies to support it, e.g. developing trial information leaflets together with people like those to be recruited. We explored whether people involved with participant recruitment have explicit planning strategies; if so, how these are developed, and if not, what prevents effective planning.MethodsDesign: Individual qualitative semi-structured interviews. Data were analysed using a Framework approach, and themes linked through comparison of data within and across stakeholder groups.Participants: 23 international trialists (UK, Canada, South Africa, Italy, the Netherlands); 11 self-identifying as ‘Designers’; those who design recruitment methods, and 12 self-identifying as ‘Recruiters’; those who recruit participants. Interviewees’ had recruitment experience spanning diverse interventions and clinical areas.Setting: Primary, secondary and tertiary-care sites involved in trials, academic institutions, and contract research organisations supporting pharmaceutical companies.ResultsTo varying degrees, respondents had prospective strategies for recruitment. These were seldom based on rigorous evidence.When describing their recruitment planning experiences, interviewees identified a range of influences that they believe impacted success:The timing of recruitment strategy development relative to the trial start date, and who is responsible for recruitment planning.The methods used to develop trialists’ recruitment strategy design and implementation skills, and when these skills are gained (i.e. before the trial or throughout).The perceived barriers and facilitators to successful recruitment planning; and how trialists modify practice when recruitment is poor.ConclusionsRespondents from all countries considered limited time and disproportionate approvals processes as major challenges to recruitment planning. Poor planning is a mistake that trialists live with throughout the trial. The experiences of our participants suggest that effective recruitment requires strategies to increase the time for trial planning, as well as access to easily implementable evidence-based strategies.

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