Incorporating Clinical Perspectives Into the Design of Adaptive Clinical Trials: Process and Impact

• Activity Number: 58
• Type: Topic Contributed
• Date/Time: Sunday, July 29, 2012 : 4:00 PM to 5:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Roger Lewis*+
• Companies: Los Angeles Biomedical Research Institute
• Keywords: Adaptive Clinical Trials ; Clinical Trial Design

Abstract

One of the advantages of adaptive clinical trials is the ability to flexibly and carefully tailor the trial characteristics to meet the scientific and clinical goals of key stakeholders. Since an important goal of late phase clinical trials is to influence the clinical practice patterns of clinicians, when the results indicate it is appropriate to do so, it is useful to consider the perspectives of clinicians when designing late phase adaptive clinical trials. The speaker, who is a clinician actively involved in the design, implementation, and oversight of adaptive clinical trials, will describe the opportunities and challenges associated with incorporating clinicians into the trial design process. Experience gained from recent work with clinical investigators from a large, federally-funded clinical trials network will be used to illustrate effective methods for incorporating clinical persectives into the adaptive clinical trial design process. An effective partnership between statisticians and clinicians will result in a clinical trial that is most likely to successfully answer key clinical questions and positively influence clinical care.