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.
Keywords
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Article info
Publication history
Received in revised form:
November 18,
2011
Received:
August 12,
2011
Footnotes
The authors have no conflicts of interest to declare.
Identification
Copyright
© 2012 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
