title: [Concepts for clinical testing of biological agents exemplified for vaccines].
abstract: Biologics are a heterogeneous group of substances with unique characteristics that are clearly distinguishable from classical cytotoxic drugs. Current concepts for clinical oncology drug development are mostly based on experiences obtained with cytotoxic agents and therefore do not (or not properly) account for several aspects that are crucial when it comes to the use of new biologics. This can lead to extreme cases where new substances that clearly bear a potential of antitumor efficacy do not reach needed levels of significance in clinical trials or are never introduced to advanced stages of clinical testing at all. In order to increase the number of biologics that can be successfully led through all phases of clinical development the currently established standards will have to be reconsidered and modified in such a way that they meet the specific needs of the tested biologics. It is important to mention that such an agent-specific adjustment of clinical development paradigms does not mean that the currently demanded high standards of safety and quality will have to be lowered by any means. The most striking arguments for a new clinical development paradigm are exemplified for therapeutic tumor vaccines but also hold true for related biologics.
authors.affiliation: Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, Leiden, The Netherlands. c.m.britten@lumc.nl
authors.forename: Cedrik M
authors.initials: CM
authors.lastname: Britten
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D004339:Drug Compounding / Q000592:standards; D005062:European Union; D005858:Germany; D019983:Guideline Adherence / Q000458:organization & administration*; D006801:Humans; D017410:Practice Guidelines as Topic; D012106:Research / Q000592:standards*; D014612:Vaccines / Q000009:adverse effects* / Q000627:therapeutic use*
chemical_list: D014612:Vaccines