title: Current issues relating to drug safety especially with regard to the use of biomarkers: a meeting report and progress update.
abstract: An expert group met in Leiden to review the state-of-the-art in detecting drug-related safety problems and to review the role of biomarkers and modelling techniques. It was clear that new drugs are not necessarily safer than old drugs, despite much larger clinical trial programs. Larger or longer clinical trials may be unfeasible and postmarketing surveillance is not being undertaken systematically enough to ensure safety. Biomarkers could improve drug safety by detecting drug-related signals early but determining whether the biomarker is on the causal pathway to toxicity is difficult. The maturity and utility of safety-related biomarkers varies among target organ systems. A consortium approach to assimilate a large amount of biomarker-related safety signals incorporating this information into mechanism-based models may provide a useful way forward. However no techniques will ensure that drugs are perfectly safe and communication with the public is required to achieve mutual understanding of benefit risk/balance assessments.
authors.affiliation: Discipline of Pharmacology, School of Medical Sciences, University of Adelaide, South Australia 5005, Australia. paul.rolan@adelaide.edu.au <paul.rolan@adelaide.edu.au>
authors.forename: Paul
authors.initials: P
authors.lastname: Rolan
authors.forename: Meindert
authors.initials: M
authors.lastname: Danhof
authors.forename: Donald
authors.initials: D
authors.lastname: Stanski
authors.forename: Carl
authors.initials: C
authors.lastname: Peck
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D004358:Drug Therapy / Q000379:methods / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D006801:Humans; D008954:Models, Biological
chemical_list: D015415:Biomarkers