Description of guidance statements included in the recommended minimum guidelines.
G u id e lin e O rg a n iz a tio n o r A u th o rs Y e a r P ro g ra m C o u n tr y o r R e g io n G u id e lin e s u b je ct e d to in d e p e n d e n t e xt e rn a l re v ie w ? R e se a rc h D e sig n D e sc rip tio n
Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics (Draft Guidance)
Food and Drug Administration
2010 Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) USA Yes, currently in distribution for comments Adaptive clinical trial design for confirmatory and exploratory trials
Document provides discussion of clinical, statistical, and regulatory aspects of adaptive clinical trials; design aspects that deserve special
consideration are also described.
Guidance for Industry and Staff: Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
Food and Drug Administration
2010 Center for Devices and Radiologic Health (CDRH)
USA Yes Bayesian statistical methods for medical device clinical trials
Document focuses on guidance for statistical aspects of medical device trials using Bayesian methodology.” Reflection Paper on
Methodological Issues in Confirmatory Clinical Trials Planned with an Adaptive Design European Medicines Agency 2007 Committee for Medicinal Products for Human Use (CHMP)
Europe Yes Adaptive clinical trial design in confirmatory trials
Document outlines general considerations for trials with interim
analyses; minimal
requirements that must be fulfilled for confirmatory adaptive trials are presented.
Acknowledgments
This project to develop minimum standards for the design, conduct, and evaluation of adaptive randomized clinical trials was funded by the Patient-Centered Outcomes Research Institute.
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