Trials and tribulations: the professional development of surgical trialists

Background Regulatory and professional bodies issue an ever-increasing number of guidance documents on the ethics and methods of clinical trials, but the quality of clinical trials of invasive therapeutic procedures continues to be a concern. We interviewed aspiring and accomplished surgical trialists to understand how they use guidance documents and other resources in their work. Methods We performed a qualitative research study involving semistructured interviews of a diverse sample of 15 surgical trialists. Results Professional development as a surgical trialist was haphazard, inefficient, and marked by avoidable mistakes. Four types of resources played constructive roles: formal education; written materials on clinical trials; experience with actual trials; and interpersonal interactions with peers, experts, collaborators, and mentors. Recommendations for improvement centered on education, mentoring, networking, participating in trials, and facilitation by department chairs. Conclusions The haphazard and unstructured nature of the current system is adding unnecessarily to the numerous challenges faced by surgical trialists.