GCP-Training for Family Physicians Participating in Practice-Based Clinical Drug Trials
DOI: 10.3238/zfa.2012.0081-0087german translation / full article
Introduction: In Germany, physicians participating as investigators in a clinical drug trial must be certified in ICH-GCP (International Harmonization of Good Clinical Practice) by a special training course. The content is set by a standardized curriculum which is, however, tailored to hospital physicians and researchers. Therefore, training courses often do not meet family practitioners’ (FPs) needs. To ensure successful knowledge transfer for a particular trial, a practice-based ICH-GCP training course for FPs was carried out for the first time by a university-associated clinical research organization in cooperation with two university departments of family medicine in autumn 2011. The trial is a randomized, double-blind, placebo-controlled comparative effectiveness study of immediate vs. conditional antibiotic therapy in uncomplicated urinary tract infection (Immediate versus conditional treatment of urinary tract infection – ICUTI).
Methods: Family practitioners (FPs) participating in the planned clinical trial were trained in two ICH-GCP courses with identical content. Both FPs and practice nurses were invited to participate. The team of trainers consisted of three members of a university-associated clinical research organization and two physicians of the study team. All curricular issues were covered. Theoretical and practical parts were arranged complementarily and the transferred knowledge was embedded in aspects of the planned trial. Following the training course, practical relevance and comprehensibility were evaluated.
Results: A total of 44 FPs and 17 practice nurses from two federal states attended the training (response rate 66 % [29/44]). Participants particularly appreciated the structure of the training and the supportive working environment. Of the criticism mentioned, length and redundancies of curriculum were listed most often.
Conclusions: In context with a planned drug trial and for a better understanding, the content of our ICH-GCP training was adapted to the trial requirements for FPs. The cooperation of the study team with members of a university-associated clinical research organization proved to be essential and successful.