Bias is a recognized concern among pediatric trialists; however they may be lacking the knowledge, willingness, or resources to properly address it. Internal validity did not emerge as a primary concern in the analyses, being overshadowed by issues related to the pragmatics of running a trial and the generalizability of the results. While these issues warrant a great deal of consideration, it is crucial that studies start out being methodologically rigorous as this is a prerequisite for generalizability.
The major barriers to minimizing risk of bias in trials were related to awareness and environment. With little emphasis on research methodology in clinical curricula, many investigators are not adequately prepared to design trials with high levels of internal validity or to recognize and attend to issues as they arise. The existing ad hoc training system very likely contributes to an emphasis on certain areas and a deficit in others, as demonstrated by the disproportionate focus by respondents on issues related to external validity (i.e., generalizability of study results), despite being questioned on issues relevant to internal validity (i.e., avoiding bias through methodologically rigorous design). Additionally, the predominantly negative attitudes surrounding the research process reinforce the acceptance of sub-optimal RCTs. While research findings may be valued, more effort is required to ensure that the importance of high quality research is recognized at all stages, and by all stakeholders. Pediatric oncology is often cited as a model in developing an environment that fosters research. Available infrastructure and consistency in study protocols has resulted in the successful integration of research and clinical care leading to marked improvements in survival and other outcomes [24, 36, 37]. By embracing research as a critical component of providing best care, rather than viewing it as an imposition, investigators and clinicians in oncology have shown that setting a standard for conducting rigorous trials is an achievable goal with tangible benefits and impressive health outcomes.
Positive relationships that support the development of an interest in research are particularly relevant in an environment in which most training is dependent on mentorship and reinforcement from experienced trialists. Within this context, clinician-scientists have a key role in bridging the gap between the worlds of research and clinical practice. Combining knowledge of proper methodology with an appreciation for the demands of the clinical setting will increase the likelihood of producing both valid and realistic trials. Research networks such as the Canadian Critical Care Trials Group (CCCTG) and Pediatric Emergency Research Canada (PERC) have been quite successful in using this strategy, facilitating high quality trials by promoting a positive culture of research, providing access to individuals with expertise, and offering support and collegiality [38, 39].
With a solid evidence base demonstrating the gaps in methodological quality in pediatric RCTs [1–10], the research agenda must now focus on knowledge translation. Using barriers and facilitators identified by the target end-users, it will be important to develop tailored strategies to overcome the gap between what is known about methodological processes and how trials are designed and conducted in practice. This is one of the stated aims of StaR Child Health, an international initiative dedicated to improving the quality of pediatric clinical research .
Strengths and limitations
An advantage of this study is that it combines the breadth of survey responses with the depth of interview responses, allowing for a detailed picture of the barriers and facilitators pediatric trialists face in the conduct of methodologically rigorous trials. While the response rate to the survey was low, bringing into question the representativeness of the sample, it was in line with evidence that both electronic surveys  and physician surveys  are associated with low responses. However, respondents represented a wide range of pediatric specialties, training backgrounds, and geographies, helping to give shape to the subsequent interviews. While they may have represented researchers with a higher level of interest in methodology, the survey responses were used to form the interviews, in which researchers with trial experience were of interest so as to be able to account for the barriers and facilitators in pediatric research with first-hand knowledge. The recruitment of additional survey participants from the membership of MICYRN slightly changed the balance of geographical representation; however the Canadian context was weighted heavily throughout the study, therefore our emphasis was unchanged. The response rate to requests for interview participation was also low, but with our expanded recruitment strategy we were able to achieve saturation. The interviews emphasized the Canadian context and therefore can be used to inform future developments within the national health care and research framework, as well as provide considerations relevant to other settings.