Abstract
Background: Pediatric trials to add missing data for evidence-based pharmacotherapy are still scarce. A tailored training concept appears to be a promising tool to cope with critical and complex situations before enrolling the very first patient and subsequently to ensure high-quality study conduct. The aim was to facilitate study success by optimizing the preparedness of the study staff shift. Method: An interdisciplinary faculty developed a simulation training focusing on the communication within the informed consent procedure and the conduct of the complex pharmacokinetic/pharmacodynamic (PK/PD) sampling within a simulation facility. Scenarios were video-debriefed by an audio-video system and manikins with artificial blood simulating patients were used. The training was evaluated by participants' self-assessment before and during trial recruitment. Results: The simulation training identified different optimization potentials for improved informed consent process and study conduct. It facilitated the reduction of avoidable errors, especially in the early phase of a clinical study. The knowledge gained through the intervention was used to train the study teams, improve the team composition and optimize the on-ward setting for the FP-7 funded “LENA” project (grant agreement no. 602295). Self-perceived ability to communicate core elements of the trial as well as its correct performance of sample preparation increased significantly (mean, 95% CI, p ≤ 0.0001) from 3 (2.5–3.5) to four points (4.0–4.5), and from 2 (1.5–2.5) to five points (4.0–5.0). Conclusion: An innovative training concept to optimize the informed consent process and study conduct was successfully developed and enabled high-quality conduct of the pediatric trials as of the very first patient visit.
Highlights
Despite the European Pediatric regulation aiming to bring evidence-based drug therapy to the vulnerable pediatric population, its effects are still lacking (Samiee-Zafarghandy et al, 2014)
The self-assessment survey indicated a significant increase of the ability to communicate the core elements of the clinical trial (p 0.0001) and the preparation to deal with trial-related communicative challenging situations (p 0.0002)
All sites started with levels of 95 to 100% of correct samples, which was above or in the range of their overall performance (Table 2) indicating no lag time to top quality rates in PK/PD sampling. This is the first report on the development and application of simulation-based training for improving the informed consent process and the PK/PD sampling in clinical trials
Summary
Despite the European Pediatric regulation aiming to bring evidence-based drug therapy to the vulnerable pediatric population, its effects are still lacking (Samiee-Zafarghandy et al, 2014). Even 13 years after the regulation got into force, there is still a high demand for well-investigated drug therapies and tailored medication for the pediatric population. Required pediatric trials to add missing data for evidence-based pharmacotherapy are still scarce for this vulnerable population. Key elements are the quality of the informed consent process (Koyfman et al, 2016), and a wellplanned and well-organized study conduct (Pica and Bourgeois, 2016). Pediatric trials to add missing data for evidence-based pharmacotherapy are still scarce. A tailored training concept appears to be a promising tool to cope with critical and complex situations before enrolling the very first patient and subsequently to ensure high-quality study conduct. The aim was to facilitate study success by optimizing the preparedness of the study staff shift
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