Assessing the Current Gaps Associated with Clinical Sample Bioanalysis

Abstract

Currently, the recently revised ICH E6(R3) Good Clinical Practices Guidance [1] provides no discussion pertaining to the bioanalysis of clinical trial samples. Furthermore, the harmonised published ICH M10 Bioanalytical Method Validation and Sample Analysis Guidance [2] does not refer to Good Clinical Practices (GCP) requirements and therefore the bioanalytical laboratory is left with a significant gap in guidance as to what expectations would be of the regulatory authorities associated with clinical samples in the event of an inspection. The European Bioanalysis Forum (EBF) discussions pertaining to this gap, which have gone on for 15 years, also recognize the blurred lines between the GCP and GLP (Good Laboratory Practices) in the bioanalytical laboratory [3], and even during MHRA (Medicines and Healthcare products Regulatory Agency) inspections in the United Kingdom (UK). The aim of this editorial is to assess the potential regulatory gaps in the bioanalytical laboratory when analyzing clinical samples and provide insight into how the GCPs apply to clinical sample bioanalysis.