Case Study: Improving Go/No-go Decision-Making with Custom Software

Posted by Cytel

Mar 24, 2017 9:27:00 AM

 Robust go/no-go (GNG) decision-making is essential for effectively managing risk across a clinical portfolio. In early phase development, it is particularly important to have the correct tools in place to terminate ineffective compounds quickly, while accelerating promising ones through the process. 

AstraZeneca established a quantitative standard decision-making framework across its Early Clinical Development group. While the system was working successfully, AstraZeneca wanted to further enhance
the efficiency of the existing process by reducing the burden for statisticians, who were creating their own code to generate the required decision plots. The team required a software tool that could create standardized outputs to streamline communication, save time, and extend the framework with additional features. 

 

AZCasestudyImage.png

In a close collaborative project, Cytel statisticians and software developers worked with the AstraZeneca team to create a user friendly software interface which could accommodate a Bayesian and Frequentist GNG approach, and produce consistent, high-quality decision plots. Now launched within the company, the tool has positively impacted  the way the statisticians and clinical stakeholders work together, and the speed at which decisions can be made.  

 

 

 

 

 

 

Click the button below to read the full case study. 

Case Study

 

To learn more about our custom software solutions click below. 

Custom Software

 

 

 

Further Reading

Cytel Blog: Decision Making in Early Clinical Development

 Decision Making in Early Clinical Drug Development Frewer et al,  Pharmaceutical Statistics, Article first published online: 17 March 2016

Model based Drug Development Lalonde et Al Clinical Pharmacology and Therapeutics 2007

 

Topics: Bayesian Methods, Case Study, go-no-go, biostatistics, Bayesian, custom software

The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.  Sign up for updates direct to your inbox. You can unsubscribe at any time.

 

Posts by Topic

see all

Recent Posts