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.
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.
Authors: Danielle M Wenner; Baruch A Brody; Anna F Jarman; Jacob M Kolman; Nelda P Wray; Carol M Ashton Journal: J Am Coll Surg Date: 2012-07-21 Impact factor: 6.113
Authors: Danielle M Wenner; Baruch A Brody; Anna F Jarman; Jacob M Kolman; Nelda P Wray; Carol M Ashton Journal: J Am Coll Surg Date: 2012-07-21 Impact factor: 6.113
Authors: J S Rendon; M Swinton; N Bernthal; M Boffano; T Damron; N Evaniew; P Ferguson; M Galli Serra; W Hettwer; P McKay; B Miller; L Nystrom; W Parizzia; P Schneider; A Spiguel; R Vélez; K Weiss; J P Zumárraga; M Ghert Journal: Bone Joint Res Date: 2017-05 Impact factor: 5.853