The study findings endorse the various facilitators and barriers to recruitment to clinical trials that have been identified in the existing literature. Motivation of the clinical team, good communication skills, research experience of the PI and clinical team, good trial management, research nurse support, a positive research culture and effective communication between teams and with patients have been recognised as important factors that boost recruitment [4]. Time constraints of clinicians, heavy clinical workloads, shift patterns and training and staffing issues have been recognised as important hindrances to recruitment [8].
The clinical teams recognised parents’ apprehension about their child taking an experimental medicine and their concerns about the potential adverse effects as barriers, which have been previously described as important considerations for parents when deciding for their child to participate in clinical trials [9]. Paediatricians have been found to consider trial participation as an additional burden for parents. This is similar to the perception of clinical teams in our study who expressed discomfort in approaching patients for research [9], thereby reiterating the need for mentoring and providing training and support to clinical staff. An excess amount and complexity of trial information provided in the patient information leaflets has been previously criticised, similar to the findings in this survey.
This study highlights research nurse support and the presence of designated research teams, particularly out of hours, as very important. Another factor to note is GCP training, which has been described as a ‘massive hurdle’. Engaging doctors to undertake GCP training was found to be very difficult and described as ‘time consuming, boring and not a priority for busy clinicians’. The study also found some differences in the perceptions of PIs and research nurses with regard to certain facilitators and barriers to recruitment. This highlights the need to consider varying viewpoints within a research team so that appropriate measures can be taken to facilitate recruitment, and may be useful to bear in mind when planning future trials.
An important trial-specific barrier was seeking consent from the parents of an ill child in 20 minutes, which raises the issue of an option of deferred consent being available for paediatric trials in acute or emergency settings. The UK law incorporates a deferred consent process in emergency situations for minors [10] when treatment is required urgently, urgent action is required for the purposes of the trial, consent cannot be obtained prospectively and the procedure has been approved by the ethics committee. Deferred consent has been successfully used in a recent randomised controlled trial evaluating the role of impregnated central venous catheters (impregnated with antibiotics or with heparin) or a standard central venous catheter for prevention of blood stream infections in children (the CATCH trial) [11]. For children needing a central venous catheter placement as an emergency, a written parental consent was sought after randomisation to avoid delay in treatment. A postal survey [12] investigating parents’ views about deferred consent in a paediatric emergency setting showed that the majority of parents found it acceptable. However, the death of a child during a trial in which deferred consent has been used presents a complex situation. The authors highlight the need for further evidence to guide appropriate management in these cases.
This study highlights several important factors that affect recruitment to clinical trials. The strengths of our study include an electronic survey design, use of a comprehensive, evidence-based recruitment survey tool, a wide range of responders with different roles from sites with variable recruitment performance and a good representation of sites with high response rates from PIs and research nurses at each site. E-surveys are quicker, less expensive, can be sent to multiple responders at the same time, avoid interviewer bias and allow the responders to express their views freely and anonymously, even regarding sensitive issues [13].
Responses from a range of responders with different roles and sites with different recruitment performance increased the breadth of data gathered in terms of recruitment experience and perspectives, increasing the precision and generalisability of the results. A high response rate from the PIs and at least one research nurse from each site ensured equal representation of sites in overall responses, thereby ensuring generalisability and avoiding selection and non-respondent bias.
The study has some potential limitations. The survey questionnaire has the disadvantage of respondent non-response, misinterpretation of questions or selective responder bias. To overcome these limitations, the survey questionnaire was worded in a simple and clear language and piloted prior to use. The non-responders were sent frequent email reminders.
The overall response rate was low, though we obtained a good response rate from the PIs and research nurses. The denominator included all contacts whose email addresses were available from the delegation logs; thus, it is likely that not all contacts would have received the survey if their email addresses had changed and were different at the time the survey was conducted. There was a high likelihood of people changing jobs or rotating between different NHS trusts during the 2-year duration of the trial, particularly doctors in training, nursing staff and other junior doctors, resulting in a change in their email addresses and contact details. This was pre-empted during the planning stage of this study, and extra efforts were made to receive a response from the PI and at least one research nurse per site.
The results of the survey are based on subjective experiences of clinical staff responding to the survey questionnaire and descriptive analysis of responses. We tried to overcome this limitation by achieving a good representation of sites in overall responses and analysing the PI and at least one research nurse response at each site separately. This study presents the recruitment experience of the clinical teams recruiting to the trial. Understanding the perspective of other stakeholders such as parents, young people and families is also very important.