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A survey of facilitators and barriers to recruitment to the MAGNETIC trial
Geetinder Kaur1, Rosalind L Smyth2, Colin V E Powell3
1School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. drgkaur@gmail.com.
Insights
Recruiting children to clinical trials is difficult. Understanding facilitators like motivated teams and clear communication, and barriers such as workload and consent timing, is crucial for future pediatric trial success.
Area of Science:
- Pediatric clinical trials
- Respiratory medicine
- Clinical trial methodology
Background:
- Recruitment of children to randomized controlled trials presents significant challenges.
- Understanding factors influencing pediatric trial recruitment is essential for successful study completion.
- The MAGNETIC trial, a multicenter study on nebulized magnesium for acute severe asthma in children, serves as a case study.
Purpose of the Study:
- To identify and analyze facilitators and barriers to recruiting children in the MAGNETIC trial.
- To document strategies employed to overcome identified recruitment challenges.
- To provide insights for improving pediatric clinical trial recruitment in acute settings.
Main Methods:
- A survey using a previously developed web-based tool was administered to study facilitators.
- Participants graded factors influencing recruitment on a scale of -3 (strong barrier) to +3 (strong facilitator).
- Free-text responses were collected on strategies used to mitigate barriers.
Main Results:
- Key facilitators included motivated and experienced study teams, effective communication, designated research nurses, and clear trial information.
- Major barriers comprised heavy clinical workload, staff training (Good Clinical Practice - GCP), consent process timing, and parental concerns about experimental treatments.
- Interventions like dedicated research nurses and targeted training sessions were frequently reported.
Conclusions:
- The study identified critical generic and trial-specific factors affecting pediatric recruitment in acute care settings.
- Effective strategies for overcoming recruitment barriers were documented.
- Findings offer valuable guidance for designing and conducting future pediatric clinical trials, especially in emergency situations.
Background:
Recruitment to randomised controlled trials with children is challenging. It is imperative to understand the factors that boost or hinder recruitment of children to clinical trials. We conducted a survey of facilitators and barriers to recruitment to the MAGNETIC trial, using a previously developed web-based tool.
Methods:
MAGNETIC is a multicentre randomised trial of nebulised magnesium in acute severe asthma, recruiting 508 children from 30 UK sites. Recruiters were asked to grade a list of factors from -3 to +3 depending on whether the factor was perceived as a strong, intermediate or weak barrier (-3 to -1) or facilitator (+1 to + 3), and using (0) if it was thought to be not applicable. Free text responses were invited on strategies applied to counter the identified barriers.
Results:
The commonly identified facilitators were motivation and experience of study teams, effective communication and coordination between teams at site and between sites and the Clinical Trials Unit, the presence of designated research nurses, good trial management, clinical trial publicity, simple inclusion criteria, effective communication with parents and presentation of trial information in a simple and clear manner. The commonly identified barriers were heavy clinical workload, shift patterns of work, Good Clinical Practice (GCP) training, inadequate number of trained staff, time and setting of consent seeking, non-availability of research staff out of hours and parents' concerns about their child taking an experimental medicine. Having a designated research nurse, arranging GCP training and trial-related training sessions for staff were the most commonly reported interventions.
Conclusions:
This study highlights important generic and trial-specific facilitators and barriers to recruitment to a paediatric trial in the acute setting and provides information on the recruitment strategies or interventions that were applied to overcome these barriers. This information can be very useful in informing the design and conduct of future clinical trials with children, particularly in the acute or emergency setting.
Trial Registration:
ISRCTN, ISRCTN81456894 . Registered on 15 November 2007.
