Pharmacological vs. classical approaches in the design of first in man clinical drug trials

• Published in: British journal of clinical pharmacology Vol. 83; no. 12; pp. 2807 - 2812
• Main Authors: Bogert, Cornelis A., Cohen, Adam F., Leufkens, Hubert G. M., Gerven, Joop M. A.
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 01.12.2017
• Subjects: clinical trials; Clinical Trials as Topic - methods; Databases, Factual; Dose-Response Relationship, Drug; drug development, phase I; Drug Dosage Calculations; Drug Evaluation, Preclinical - trends; Endpoint Determination - trends; Humans; methodology; Methods in Clinical Pharmacology; Netherlands; No-Observed-Adverse-Effect Level; Pharmaceutical Preparations - administration & dosage; Pharmacokinetics; Research Design - trends; statistics and study design; Time Factors; statistics and study design; clinical trials; methodology; drug development, phase I

Aims The aims of the present study were to investigate the role of pharmacology in the design of first‐in‐man (FIM) trials in the Netherlands, and to evaluate the change in design approaches between 2007 and 2015. Methods All FIM drug trials approved by all Dutch Institutional Review Boards (IRBs) i...