We have written on the blog in the past about the value that a statistical consultant can bring to your team, and to the overall clinical development process. Statistical consultants can be instrumental to the success of your development program, providing a variety of input from creating innovative trial designs that improve information quality and efficiency, to supporting regulatory interactions.
Increasingly, our team contributes its specialized pharmacometrics consulting expertise, bringing another valuable dimension to sponsors’ clinical development programs. By using pharmacometrics strategies alongside more traditional statistical planning, we can help our customers to quantitatively inform on the benefit:risk ratio, quantify the competitive landscape and reduce the inherent risks associated with drug development.
While a statistical consulting relationship often centers on study design and planning aspects, the focus of pharmacometrics consulting tends to be on interpretation of results from studies, and learning and predicting from the existing data. This is an important point, as it is a fairly common misconception that traditional statistical approaches, such as ANOVA (analysis of variance), are the only way to understand study results. In fact, pharmacometric models can add tremendous value to our understanding of the data by providing context or contributing additional information.
This concept can be illustrated with a simple example in which a sponsor uses ANOVA to understand if the response to the drug was greater than the response to placebo. Pharmacometric modelling approaches may then go a step further to help understand at what dose efficacious or safety-related results may be seen; or how long it will take to achieve a response; or to determine whether some subjects have a markedly different response than others.
Importantly, a pharmacometrician can help clinical development teams to frame scientific questions in an objective and quantifiable way that enable unbiased interpretations of the data. Most clinical development teams understand the concerns for their drug extremely well. Addressing these concerns in a quantitative and definitive way is a common gap that pharmacometrics consulting can help to bridge. For example, the team may know that particular side effects are issues for drugs of a certain class, and want to understand if the same side effects are going to be an issue for their own drug. However, they may not be able to define exactly how they will use their current study designs and their historical data to demonstrate whether there is indeed any cause for concern. By properly defining the question and the corresponding analyses, we can equip your team to confidently discuss the risks and benefits of the test compound with key stakeholders.
Here are several key project types that our pharmacometrics consultants can support:
- Define objective and quantifiable research questions or objectives.
- To use dose (and/or exposure) response modeling to inform on decision-making within adaptive designs.
- Help to review the clinical development program as well as individual studies to enhance the likelihood of informative results.
- Translate preclinical to clinical data.
- Characterize the therapeutic index of your compound.
- Help to interpret difficult study results with quantitative techniques.
- Help to identify populations most likely to respond favorably (or unfavorably) to your compound.
- Characterize your drug with regard to the competitive landscape.
- Assist with regulatory interactions and concerns.
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About the Author
Cecilia Fosser is Director, Quantitative Pharmacology and Pharmacometrics at Cytel. She combines statistical and pharmacometrics techniques to develop advanced approaches for quantitative drug development. Her experience includes Phases 1–4 of clinical trial development and spans a range of therapeutic areas. In the past, she has worked with Pfizer’s Pharmacometrics Group, with a focus on inflammation.
Her publications include work on exposure-response analyses of multiple endpoints. She has delivered presentations at several large international conferences such as ASCPT and ACoP. Cecilia obtained a PhD in Applied Mathematics from the University of Arizona.