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What is the purpose of the adaptive design clinical trials?

Adaptive design clinical trials are widely used in the development of medical devices. And now, the lessons learned from those studies are being applied to drug development. The adaptive design may reduce the number of patients in a trial and the total number of trials. Modifiable design experiments may yield more informative experimental results. The additional flexibility offered by a customizable design may increase acceptance for stakeholders.

What can be solved in the adaptive experiment?

Modifications are common in experimental adaptive designs, though. Not all modifications are suitable for every trial. You should carefully consider what aspects of "adaptation" are, as improper selection or extreme flexibility can lead to bias. Examples of future planned adjustments that may be included in the adaptive design trial include:

  • Adaptation to random steps
  • Discard or increase the arm or therapeutic dosage.
  • Adaptation to sample size based on interim results
  • Adaptation to the patient population
  • Predefined stop rules for efficiency or futility.

What are the four primary considerations for adaptive design?

The 2019 FDA guidance outlines four fundamental principles to consider when designing adaptive design trials:

  • Controlling the likelihood of wrong conclusions
  • treatment outcome estimates
  • Trial planning
  • Maintaining Conduct and Integrity in Trial

Potential Challenges of Adaptive Design:

Adaptive designs tend to work best and are less susceptible to minor problems for programs with significant uncertainty about many parameters conducting an exploratory experiment before designing an experiment that "Adequate control" may provide at least some additional insights into these parameters. This can be decrease the uncertainty and make the approach more efficient and informative. In particular, in Stage II and Stage III trials, it may lead to uncertainty in outcomes.

Finally, adaptive designs may not be the best choice for all clinical trials. This includes short-term studies (e.g., 2-8 weeks) in populations that can be very selective (e.g., less than 3-6 months) because supply has to be temporarily stopped at the analysis time. It may be appropriate for more comprehensive studies where interim data from short-term endpoints (e.g., at six weeks) are used to predict long-term endpoints (e.g., 6-12 months) since patient discontinuation. 

Conclusion:

Adaptive designed clinical trials may have significant advantages over conventionally designed trials. This includes the flexibility to make future planned adjustments to some aspects of the study design and achieve more informative and practical outcomes. However, implementing adaptive designs is not without risk. Therefore, all study design decisions must be carefully considered and identified in the future.

Source: https://www.apsense.com/article/what-is-the-purpose-of-the-adaptive-design-clinical-trials.html

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