Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency

Adaptive Design

(2014) Caroline Claire Morgan et al.   Therapeutic Innovation & Regulatory Science

Interim Design Modifications in Time-to-Event Studies

(2012) Sebastian Irle et al.   JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION

Impacts on type I error rate with inappropriate use of learn and confirm in confirmatory adaptive design trials

(2010) Sue-Jane Wang et al.   BIOMETRICAL JOURNAL

An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints†

(2010) Martin Jenkins et al.   PHARMACEUTICAL STATISTICS

Adaptive increase in sample size when interim results are promising: A practical guide with examples

(2010) Cyrus R. Mehta et al.   STATISTICS IN MEDICINE

Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency

(2009) Jan Regnstrom et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Adaptive designs for confirmatory clinical trials

(2009) Frank Bretz et al.   STATISTICS IN MEDICINE

Adaptive Dunnett tests for treatment selection

(2007) Franz Koenig et al.   STATISTICS IN MEDICINE