Drug development is an expensive and risky business. To maximize a compound’s ultimate chances of commercial as well as regulatory success it’s imperative that sponsors are building up a strong understanding of its characteristics relative to competitors. This knowledge can support critical decisions along the development path, such as optimizing dosing, and selecting the best active control. Importantly, it also ensures the sponsor can build a body of evidence and quantify the benefits of the compound in the context of other treatment options. This knowledge can streamline the path to drug approval and support the drug’s chances of commercial success when it reaches the market.
Model based meta- analysis (MBMA) is becoming an increasingly utilized strategy to conduct this competitive benchmarking.
Some MBMA applications are highlighted in a recent Feb 16 publication (Boucher and Bennetts 2016):
Identifying a disease level desired profile
Learning and hypothesis generating
Generating target values for decision-making
Simulating new studies based on internal patient level data and external Standard of Care data
In order to ease the process of conducting model based meta-analysis, Cytel Pharmacometricians have developed a Comparator Outcome Database approach. Using publicly available clinical trial data, the team are able to extract summary level clinical outcome data along with detailed information on treatment, patient population, and trial characteristics. The databases are scoped and developed in line with our clients’ specific requirements and can be used to answer critical research questions from early development right through to post registration.
At the inaugural conference of the International Society for the Study of Xenobiotics, Cytel Associate Director of Biostatistics Nand Kishore Rawat, and other colleagues from the Cytel Quantitative Pharmacology and Pharmacometrics team presented a poster presentation Clinical Pharmacology Comparator Database Modelling Perspective.
To view the poster, click the link below.
(1) Boucher, M. and Bennetts, M. (2016) ‘The many flavors of model-based Meta-Analysis: Part i-introduction and landmark data’,CPT: Pharmacometrics & Systems Pharmacology, 5(2), pp. 54–64. doi: 10.1002/psp4.12041.