Clinical trial design and interpretation
Asking the right questions and getting the right information for better decisions
Clinical Trial Design and Interpretation (Clinical Trial D&I) is about designing and interpreting clinical trials to determine the effectiveness, value and safety of our drugs. It will ensure that everyone has the tools, resources, training and capabilities needed to drive best practice into normal practice. These improvements will reduce the average size, cost and complexity of our clinical studies and programmes, improve efficiency by reducing the need for re-work, and provide clear options for better design decisions.
Tralokinumab, an anti-interleukin 13 (IL-13) monoclonal antibody (mAb) medicine to improve asthma control, saw encouraging results in Phase IIa. While preparing to transition to Phase IIb, the project team piloted a new design process. Design Remit enables all team members to establish what questions must be asked and answered in the next study in order to obtain the information necessary to make the next investment decision.
The Design Remit process helped determine that more information was required to see if the antibody could reduce the frequency of asthma attacks. The trial was designed to answer this question. As a result, the business will be in a position at the end of Phase II to make a more informed decision about progressing Tralokinumab to Phase III.