Using qualitative research to ensure clinical trial success in challenging settings

Introduction: Many publicly-funded clinical trials fail to reach their target sample size, leading to costly extensions or trial closure. Both issues can cause unnecessary burden on families and delay vital evidence to improve treatments. In pediatric emergency or surgical settings there are additional challenges to recruitment, such as how and when consent should be sought without burdening families of sick children. Involving patients, families and clinical trial staff in the design and conduct of challenging clinical trials through qualitative research may help identify and address potential barriers to recruitment and ensure processes are in line with the priorities of families.
Goals: To use qualitative methods, informed by the Theoretical Framework of Acceptability, to identify challenges and maximise impact of NIHR-funded studies (ToSCIN, EcLIPSE). Methods: Thematic analysis of 54 interviews, 12 focus groups and (for EcLIPSE) 76 recorded trial recruitment discussions with parents and practitioners.
Results Qualitative data can provide insight into parental views on trial acceptability and appropriate consent processes that can be used to address practitioner concerns about the burden of recruitment. For practitioners, an online focus group can provide the flexibility to involve staff from multiple sites whilst interviews with parents help ensure their individual perspectives are heard. Practitioners may be reticent to record recruitment trial discussions but the insight gained can identify issues, such as lack of equipoise or poor explanations, which may impact on parent understanding and willingness to consent. Social media advertising is an effective means of recruiting to interviews but researchers should consider how to manage the issue of potentially fraudulent participants.
Conclusions: Qualitative research provides rich insight to develop trial protocols and staff training so that trials are family-centred and more likely to reach recruitment targets. Tailoring approaches to qualitative methods by participant can help increase engagement and the quality of data.