Abstract
BackgroundVariability in pre-analytical procedures such as blood sampling, sample preparation and transport can substantially influence bioanalytical results and subsequently impair reliability of data gathered during clinical trials. Especially in vulnerable populations, all efforts should be made to facilitate high-quality data extraction excluding unnecessary or repeated intervention.MethodsThe EU-funded LENA project (Labeling of Enalapril from Neonates up to Adolescents) included a feasibility study in its preparatory procedures prior to first-in-child studies. Derived from a regular study visit, it encompassed all procedures, from sampling of two study-specific drugs and four sensitive humoral parameters to bioanalysis, to evaluate the quality of obtained samples and applicability of logistical and bioanalytical procedures. Drug administration to healthy adults was circumvented by pre-spiking the blood collection tubes with a drug solution. Five clinical sites were evaluated.ResultsClinical teams' preparedness and applicability of required sampling procedures was investigated in 18 volunteers, on-site. 97% of collected pharmacokinetic (PK) samples and 93% of samples for humoral parameters were obtained eligibly. Results met expectations, though one team had to be re-trained and performed a re-run. Planned procedures for sampling, sample preparation, transport and analysis were found to be suitable for being applied within paediatric trials.ConclusionThe concept of the presented feasibility study that simultaneously assesses PK/PD sampling, sample preparation, logistics and bioanalysis proved to be a promising tool for trial preparation. It revealed improperly installed processes and bottlenecks that required adjustments prior to start of recruitment. It facilitated high-quality conduct from the first moment of paediatric pivotal studies.
Highlights
The quality of pre-analytical procedures such as blood sampling as well as sample preparation and transport can considerably affect the results of bioanalytical determinations
The demanding sampling and sample preparation procedures have already been subject to joint, comprehensive training for involved clinical teams, prior to the presented feasibility study
Between November 2015 and March 2016, five clinical centres involved in the LENA project (83% of all clinical sites at this stage) performed the on-site feasibility study
Summary
The quality of pre-analytical procedures such as blood sampling as well as sample preparation and transport can considerably affect the results of bioanalytical determinations. Pre-analytical procedures ought to be standardised in advance, especially for trials in vulnerable populations, to prevent unnecessary or repeated interventions This is typically done only through a short training of staff during the site initiation visit for a clinical trial. Conclusion: The concept of the presented feasibility study that simultaneously assesses PK/PD sampling, sample preparation, logistics and bioanalysis proved to be a promising tool for trial preparation It revealed improperly installed processes and bottlenecks that required adjustments prior to start of recruitment. It facilitated highquality conduct from the first moment of paediatric pivotal studies
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