Perception and use of adaptive designs in the industry and academia: persistent barriers and recommendations to overcome challenges

• Activity Number: 117
• Type: Topic Contributed
• Date/Time: Monday, July 30, 2012 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Alun Bedding*+
• Companies: GlaxoSmithKline
• Keywords: Adaptive Designs ; Simulation

Abstract

The DIA adaptive design scientific working group have conducted a survey of the perception and use of adaptive designs (ADs) for clinical development programs in the industry and academia. In this presentation, the results of the survey will be presented and compared to the results of a previous survey carried out by the same group in 2008 under the auspices of PhRMA [1].

The key objectives of the survey were to identify any persistent barriers to implementing such designs and provide recommendations to overcome these challenges. The questionnaire was sent out to a wide selection of organizations in September 2011 to enquire about ADs that were planned, ongoing or completed in their organization from 1st January 2008 to 1st September 2011.

In parallel, the medical and statistical literature and clinical trial registries were reviewed by the group to identify published AD case studies and consider to what extent the literature is representative of the information gathered in the questionnaire. The results of this review will also be presented.

[1] Quinlan J. et al. Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development. Clin Trials 2010; 7:167-173