Question

Discuss the use of adaptive clinical trial design in the development of medicinal products for human use. What do you think are some of the pitfalls of adaptive research design for clinical trials as compared to traditional clinical trial design?

Answer 1

Adaptive designs can make clinical trials more flexible by utilising results accumulating in the trial to modify the trial’s course in accordance with pre-specified rules.

1. There are more efficient, informative.
2. They often make better use of resources such as time and money, and might require fewer participants.
3. Adaptive designs can be applied across all phases of clinical research, from early-phase dose escalation to confirmatory trials.
4. Adaptive designs (ADs) provide an alternative. They have been described as ‘planning to be flexible‘driving with one’s eyes open’ or ‘taking out insurance’ against assumptions. They add a review–adapt loop to the linear design–conduct–analysis sequence .
5. Traditionally, clinical trials have been run in three steps [

The trial is designed.

The trial is conducted as prescribed by the design.

Once the data are ready, they are analysed according to a pre-specified analysis plan.

This practice is straightforward, but clearly inflexible as it does not include options for changes that may become desirable or necessary during the course of the trial.