Sample Size Re-estimation Designs In Confirmatory Clinical Trials—Current State, Statistical Considerations, and Practical Guidance

Not Too Big, Not Too Small: A Goldilocks Approach To Sample Size Selection

(2014) Kristine R. Broglio et al.   Journal of Biopharmaceutical Statistics

A review and re-interpretation of a group-sequential approach to sample size re-estimation in two-stage trials

(2014) J. Bowden et al.   PHARMACEUTICAL STATISTICS

Adaptive Design

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

Effect of Platelet Inhibition with Cangrelor during PCI on Ischemic Events

(2013) Deepak L. Bhatt et al.   NEW ENGLAND JOURNAL OF MEDICINE

Exact inference for adaptive group sequential designs

(2013) Ping Gao et al.   STATISTICS IN MEDICINE

Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials

(2013) Zoran Antonijevic et al.   Therapeutic Innovation & Regulatory Science

Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development

(2012) Brenda Gaydos et al.   DRUG INFORMATION JOURNAL

Interim Design Modifications in Time-to-Event Studies

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

Assumptions of Expected Benefits in Randomized Phase III Trials Evaluating Systemic Treatments for Cancer

(2012) H. K. Gan et al.   JNCI-Journal of the National Cancer Institute

Adaptive extensions of a two-stage group sequential procedure for testing primary and secondary endpoints (I): unknown correlation between the endpoints

(2012) Ajit C. Tamhane et al.   STATISTICS IN MEDICINE

Adaptive extensions of a two-stage group sequential procedure for testing primary and secondary endpoints (II): sample size re-estimation

(2012) Ajit C. Tamhane et al.   STATISTICS IN MEDICINE

Paradigms for adaptive statistical information designs: practical experiences and strategies

(2012) Sue-Jane Wang et al.   STATISTICS IN MEDICINE

Predictive event modelling in multicenter clinical trials with waiting time to response

(2011) Vladimir V. Anisimov   PHARMACEUTICAL STATISTICS

Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development

(2010) Judith Quinlan et al.   Clinical Trials

Sample size re-estimation in a breast cancer trial

(2010) Erinn M Hade et al.   Clinical Trials

Many-to-One Comparison After Sample Size Reestimation for Trials with Multiple Treatment Arms and Treatment Selection

(2010) Jixian Wang   Journal of Biopharmaceutical 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

Sample size re-estimation in clinical trials

(2009) Michael A. Proschan   BIOMETRICAL JOURNAL

Optimizing Trial Design

(2009) Cyrus Mehta et al.   CIRCULATION

Exact Confidence Bounds Following Adaptive Group Sequential Tests

(2008) Werner Brannath et al.   BIOMETRICS

Sample Size Re-Estimation for Adaptive Sequential Design in Clinical Trials

(2008) Ping Gao et al.   Journal of Biopharmaceutical Statistics