Trials and tribulations: the professional development of surgical trialists

Abstract

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.