Abstract
Objectives: To explore trial site staff's perceptions regarding barriers and facilitators to local recruitment.
Design: Qualitative semi-structured interviews with a range of trial site staff from four trial sites in the UK. Interviews were analysed thematically to identify common themes across sites, barriers that could be addressed and facilitators that could be shared with other sites.
Participants: 11 members of staff from four trial sites: clinical grant Co-applicant (n=1); Principal Investigators (n=3); Consultant Urologist (n=1); Research Nurses (n=5); Research Assistant (n=1).
Setting: Embedded within an ongoing randomised controlled trial (the TISU trial). TISU is a UK multicentre trial comparing therapeutic interventions for ureteric stones.
Results: Our study draws attention to the initial and ongoing burden of trial work that is involved throughout the duration of a clinical trial. In terms of building and sustaining a research culture, trial staff described the ongoing work of engagement that was required to ensure that clinical staff were both educated and motivated to help with the process of identifying and screening potential participants. Having adequate and sufficient organisational and staffing resources was highlighted as being a necessary prerequisite to successful recruitment both in terms of accessing potentially eligible patients and being able to maximise recruitment after patient identification. The nature of the research study design can also potentially generate challenging communicative work for recruiting staff which can prove particularly problematic.
Conclusions: Our paper adds to existing research highlighting the importance of the hidden and complex work that is involved in clinical trial recruitment. Those designing and supporting the operationalisation of clinical trials must recognise and support the mitigation of this ‘work’. While much of the work is likely to be contextually sensitive at the level of local sites and for individual trials, some aspects are ubiquitous issues for delivery of trials more generally.
Design: Qualitative semi-structured interviews with a range of trial site staff from four trial sites in the UK. Interviews were analysed thematically to identify common themes across sites, barriers that could be addressed and facilitators that could be shared with other sites.
Participants: 11 members of staff from four trial sites: clinical grant Co-applicant (n=1); Principal Investigators (n=3); Consultant Urologist (n=1); Research Nurses (n=5); Research Assistant (n=1).
Setting: Embedded within an ongoing randomised controlled trial (the TISU trial). TISU is a UK multicentre trial comparing therapeutic interventions for ureteric stones.
Results: Our study draws attention to the initial and ongoing burden of trial work that is involved throughout the duration of a clinical trial. In terms of building and sustaining a research culture, trial staff described the ongoing work of engagement that was required to ensure that clinical staff were both educated and motivated to help with the process of identifying and screening potential participants. Having adequate and sufficient organisational and staffing resources was highlighted as being a necessary prerequisite to successful recruitment both in terms of accessing potentially eligible patients and being able to maximise recruitment after patient identification. The nature of the research study design can also potentially generate challenging communicative work for recruiting staff which can prove particularly problematic.
Conclusions: Our paper adds to existing research highlighting the importance of the hidden and complex work that is involved in clinical trial recruitment. Those designing and supporting the operationalisation of clinical trials must recognise and support the mitigation of this ‘work’. While much of the work is likely to be contextually sensitive at the level of local sites and for individual trials, some aspects are ubiquitous issues for delivery of trials more generally.
| Original language | English |
|---|---|
| Pages (from-to) | 1-8 |
| Number of pages | 8 |
| Journal | BMJ Open |
| Volume | 7 |
| Issue number | 8 |
| Early online date | 11 Aug 2017 |
| DOIs | |
| Publication status | Published - Aug 2017 |
Bibliographical note
AcknowledgmentsThe authors would like to thank all interviewees who agreed to take part in this study. The authors would like to thank the TISU Trial Group for their support with this project. In particular, the authors would like to thank Sarah Cameron (TISU Trial Manager) for her help in identifying and recruiting staff from the various TISU trial study sites.
Funding
ZCS was supported by a core grant from the CSO (reference CZU/3/3) and a Wellcome Trust Institutional Strategic Support Fund award (reference RG12724-18). KG was supported by an MRC Methodology Research Fellowship (MR/L01193X/1). Transcription costs were supported by the National Institute for Health Research (NIHR), HTA programme (TISU project number 10/137/01). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, National Health Service or the Department of Health.
Fingerprint
Dive into the research topics of '“It’s trying to manage the work”: A qualitative evaluation of recruitment processes within a UK multi-centre trial'. Together they form a unique fingerprint.Profiles
-
Kate Gillies
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Personal Chair
- Institute of Applied Health Sciences
Person: Academic, Academic Related - Research
-
Zoe Skea
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Lecturer (Scholarship), Research Fellow
Person: Academic Related - Scholarship, Academic Related - Research
-
Shaun Treweek
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Chair in Health Services Research
- Institute of Applied Health Sciences
Person: Academic