Adaptive trial designs: understanding the potential of statistical innovation

November 23, 2021 By admin
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As the clinical development landscape changes rapidly, so does the interest in ways trial sponsors can accelerate research and development programs while reducing inefficiencies, time and related cost. According to ClinicalTrials.gov, in 2020 alone, there were nearly 400 trials using adaptive designs. In comparison, from 2005 to 2018, there were less than 300 trials in total using these approaches.

The rapid increase in adaptive trials is likely tied to the FDA guidance on complex and innovative trials. Adaptive trials preserve the statistical validity of the analysis at the conclusion of the trial, even with the trial adapting to incoming data. Because these trials can respond to the data, sponsors are able to make better use of the data, which increases study efficiencies and accelerates treatment development, while also maintaining scientific and statistical integrity.

Adaptive designs can be applied across all phases of clinical research, but depending on the stage of clinical development, certain designs may be more useful than others. Guidance from experienced biostatisticians is critical to pairing the adaptive design option with development phase and trial objectives. We will briefly talk about some common adaptive design types, and their uses.

Adaptive design options

There are several new but underutilized adaptive design studies that are available to sponsors and worth consideration:

IQVIA’s statisticians have been designing and executing adaptive designs for over 20 years. Though adaptive trial design may take longer in upfront planning, through high level expertise and tech-enabled solutions, these models can help reduce overall timelines and provide seamless transitions from phases of development while ensuring adaptations made in the process are helping to maximize the probably of trial success, better meeting patient needs and sponsor goals.

Please contact GlobalFSPGTM@iqvia.com directly to learn more about IQVIA capabilities specific to adaptive trial design, please visit iqvia.com/biostatistics

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