Confidentiality and Trial Integrity Issues for Adaptive Designs
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Confidentiality and Trial Integrity Issues for Adaptive Designs
Paul Gallo, PhD
Director. Biostatistics. Novariis Pharmaceuticals. East Hanover. NewJersey
Key Words
Interim analysis; DataMonitoring Commillee; Unblinded data; Seamless design
Correspondence Address
Paul Gallo. Biostatistics and Statistical Reporting, Novartis Pharmaceuticals. One Health Plaza. East Hanover. NJ 07936-1016 (e-mai/: [email protected]). The DrugInformation Association is accredited by the Accreditation Council for Pharmacy Education as a provider of Continuing pharmacy education. This program is designated for a maximum of 1 contacthouror .1 continuing education units (CEUs). 286-000-06-400-H04. Ifyou would liketo receive a statement of credit, you must review the article. answer the questions to the post-test on the Post-Test and Evaluation Form and submit it to DIA. Parlicipants must receive a passing score of 80% or beller on the post-testin orderto receive a statement of credit. Statementsof credit will be mailed withinone month of receipt of the Post-Test and evaluation Form. There is no fee to receive your statement of credit.
Adaptive design trials raise important issues regarding processes for review of interim data and implementation of adaptation decisions, while avoiding bias and maintaining interpretability of trial results. We discuss the
issues, distinctions versus more familiar monitoring situations, various aspects of operational models fordata monitoring, andtypes of adaptations that may be more or less prone to concerns about bias.
Learning Objectives • Understanding the importance of restricting knowledge ofinterim results in confirmatory adaptive trials • Discuss methods to avoid bias andmaintain theinterpretability of trial results in adaptive designs • Describe operational models fordata monitoring in anadaptive trial Target Audience This article is designed forclinicians, statisticians, andother health care professionals interested in utilizing adaptive clinical trial designs.
INTRODUCTION Conventions have arisen regarding limitation of access to accruing unblinded data and comparative results in clinical trials. with the goal of maintaining the integrity of trial results and minimizing potential for bias. Interim analyses are of course a common feature of clinical trials; major motivations for performing them include monitoring data for potential safety concerns, application of formal group sequential methods to allow stopping of the trial with a claim for efficacy if a standard of proof can be met, and consideration of stopping for futility if it seems clear that a trial will not achieve its objectives. Current conventions, particularly in confirma-
Release Date: November 2006 Expiration Date: November 30, 2007 Estimated time to complete the activity: J hour
tory trials, generally hold that interim results and unblinded data should not be accessible to trial personnel, whether sponsor or external personnel managing trial operations, or to study investigators. The rationale behind the regulatory
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