Good study design includes thoughtful planning and involves bringing subject matter experts, like statisticians, in early. Statisticians can take existing or historic trial data for a particular disease area and create hypothetical scenarios that can inform the shaping of a tighter, better-designed trial. Good planning hones each aspect of a trial making it responsive, integrative of candidate data, and improves return on investment.
How do we launch a trial that is good by design? By making it adaptive. An approach to clinical trials popularized in the mid-1990s, Adaptive-By- Design allows for adjustments and modifications during the clinical trial, making the study responsive in real-time, particularly when paired with an eCRF – but that’s for another article.
Adaptive design helps sponsors determine if the therapy is going to fail, and if so, to help it fail early, shortening timelines and reducing costs. We know that analysis is inextricably tied to the study of design; when you decide on a design, you are largely deciding on the analysis.
Bearing this in mind, let’s look at two case study scenarios that illustrate the benefits of Adaptive Trial Design.