Who is the target audience of PANDA?
PANDA is aimed at trialists and researchers in clinical trials who are keen to learn about adaptive designs, their practical application, potential benefits and limitations. The target audience includes, but is not limited to, trial statisticians, clinicians, health economists, grant proposal developers, trial managers, data managers, and reviewers of grant applications. The user will be able to explore a range of adaptations that may be used in clinical trials and determine which method(s) are most appropriate to help them answer their research questions. PANDA has a practical focus, taking the user from the planning and design of an adaptive trial through to its conduct and reporting of interim and final analyses.
What is the scope of PANDA?
To make PANDA as useful as possible, it covers the following topics:
- what is an adaptive design, what are the goals of different types of adaptive designs, and what sort of research questions can they help address?
- potential benefits and limitations of adaptive designs, including when an adaptive design is appropriate and when it is not
- advice on explaining adaptive designs to key stakeholders such as funders, regulators, and trial participants
- costing a trial using an adaptive design in a grant application
- how to write a trial protocol for a trial using an adaptive design
- how to minimise operational and statistical bias when running an adaptive trial
- statistical methods underpinning different adaptive designs, focusing on the design (including sample size calculation), monitoring, analysis and reporting
- how to include health economics analysis in trials using an adaptive design
PANDA also provides key resources to help researchers use adaptive designs in practice, including:
- statistical software to help with the design (including sample size calculation), monitoring, analysis and reporting of a clinical trial using an adaptive design
- case studies and examples showing how to design, communicate, monitor and analyse a clinical trial using different adaptive designs
- guidance to enhance the reporting of adaptive designs
- a blog section that offers a platform to share and learn from other trialists' experiences
This initial version of PANDA does not cover adaptive designs in early phase trials (such as designs for dose escalation), although there is scope to incorporate this in the future.