Improving the assessment of the probability of success in late stage drug development-Reference-Cited by-同舟云学术

Improving the assessment of the probability of success in late stage drug development

Published:2021-12-14 Issue: Volume: Page:
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Hampson Lisa V.¹^ORCID,Bornkamp Björn¹^ORCID,Holzhauer Björn¹^ORCID,Kahn Joseph²,Lange Markus R.¹,Luo Wen‐Lin²,Cioppa Giovanni Della³,Stott Kelvin⁴,Ballerstedt Steffen¹

Affiliation:

1. Analytics Novartis Pharma AG Basel Switzerland

2. Analytics Novartis Pharmaceuticals Corporation East Hanover New Jersey USA

3. Clinical R&D Consultants srl Rome Italy

4. Portfolio Analytics Novartis Pharma AG Basel Switzerland

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2179

Reference45 articles.

1. A review of Bayesian perspectives on sample size derivation for confirmatory trials;Kunzmann K;Am Stat,2021

2. Assurance in clinical trial design;O'Hagan A;Pharm Stat,2005

3. Bayesian predictive power: choice of prior and some recommendations for its use as probability of success in drug development;Ruifbach K;Pharm Stat,2016

4. Sequentially updating the likelihood of success of a phase 3 pivotal time‐to‐event trial based on interim analyses or external information;Rufibach K;J Biopharm Stat,2016

5. Practical experiences of adopting assurance as a quantitative framework to support decision making in drug development;Crisp A;Pharm Stat,2018

Cited by 5 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Going beyond probability of success: Opportunities for statisticians to influence quantitative decision‐making at the portfolio level;Pharmaceutical Statistics;2024-01-11

2. Algorithmic benchmark modulation: A novel method to develop success rates for clinical studies;Clinical Trials;2023-11-20

3. Model‐informed drug development of autologous CAR‐T cell therapy: Strategies to optimize CAR‐T cell exposure leveraging cell kinetic/dynamic modeling;CPT: Pharmacometrics & Systems Pharmacology;2023-07-28

4. Eliciting judgements about dependent quantities of interest: The SHeffield ELicitation Framework extension and copula methods illustrated using an asthma case study;Pharmaceutical Statistics;2022-04-03

5. A New Comprehensive Approach to Assess the Probability of Success of Development Programs Before Pivotal Trials;Clinical Pharmacology & Therapeutics;2021-12-13