Links to regulatory information

A collection of links to key articles on regulatory compliance and clinical trials

FDA: Guidance for Industry End-of-Phase 2A Meetings (2009)

FDA: Draft Guidance for Industry and FDA Staff: Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (2006)

2nd EMEA-EFPIA Workshop on Adaptive Design in Confirmatory Clinical Trials – London/United Kingdom – 2 April 2009

Brenda Gaydos, Ph.D.Research Advisor, Phase 2/3 adaptive design utilizing a Bayesian decision analytic approach to dose selection, 2nd EMEA-EFPIA Workshop on Adaptive Design in Confirmatory Clinical Trials – London/United Kingdom – 2 April 2009

EMEA: REFLECTION PAPER ON METHODOLOGICAL ISSUES IN CONFIRMATORY
CLINICAL TRIALS PLANNED WITH AN ADAPTIVE DESIGN (2007)