FDA draft guidance on adaptive design clinical trials: Pfizer's perspective
Related Experiment Video
Updated: Jun 6, 2026

Chimeric Antigen Receptor T Cell Manufacturing on an Automated Cell Processor
Published on: August 18, 2023
Christy Chuang-Stein1, Mohan Beltangady
1Statistics, Pfizer, Inc., Kalamazoo, Michigan, USA. Christy.j.chuang-stein@pfizer.com
Abstract:
The Food and Drug Administration of the United States issued a draft guidance on adaptive design clinical trials in February 2010. This draft guidance has attracted a lot of attention because of the increasing interest in adaptive trials by the pharmaceutical industry in recent years. In this paper, we report on highlights of comments collected within Pfizer on this draft guidance. In addition, we share Pfizer's internal journey to promote efficient trial designs since 2005. Adaptive designs have been part of that journey.
Related Concept Videos
Clinical Trials: Overview
Biopharmaceutical Factors Influencing Drug Product Design: Overview
Preclinical Development: Overview
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Clinical Trials
There are four phases in a clinical trial. A phase one...
FDA Approved Drugs: Changes to Approved Drugs

