Bayesian adaptive designs in single ascending dose trials in healthy volunteers

• Published in: British journal of clinical pharmacology Vol. 78; no. 2; pp. 393 - 400
• Main Authors: Guédé, David, Reigner, Bruno, Vandenhende, Francois, Derks, Mike, Beyer, Ulrich, Jordan, Paul, Worth, Eric, Diack, Cheikh, Frey, Nicolas, Peck, Richard
• Format: Journal Article
• Language: English
• Published: England Blackwell Science Inc 01.08.2014
• Subjects: Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Bayes Theorem; Bayesian adaptive design; Clinical Trials, Phase I as Topic - methods; Clinical Trials, Phase I as Topic - standards; Computer Simulation; Data Interpretation, Statistical; Dose-Response Relationship, Drug; Healthy Volunteers; Humans; Maximum Tolerated Dose; Methods in Clinical Pharmacology Series; safety; Sample Size; single ascending dose trial; single ascending dose trial; safety; Bayesian adaptive design

Aim Recent publications indicate a strong interest in applying Bayesian adaptive designs in first time in humans (FTIH) studies outside of oncology. The objective of the present work was to assess the performance of a new approach that includes Bayesian adaptive design in single ascending dose (SAD)...