Adaptive Clinical Trials
Discover how adaptive trials are transforming clinical research. Berry leads the industry with expert trial designs that learn, evolve, and optimize as new data emerges — reducing costs, accelerating timelines, and improving patient outcomes.
What is an Adaptive Trial?
To understand adaptive trials it may be easiest to look at a fixed trial. Traditionally a fixed sample size is specified with fixed allocation and fixed entry criteria. The data are not analyzed until trial completion, which is typically years after the trial began. This 75-year-old design approach creates very restrictive design types – and really forces the design team to guess at the doses, range, patient population, duration and frequency of treatment, etc, because a fixed design requires linear effort spent for each treatment arm.
Key Advantages of Adaptive Trials
Innovative Dosing Decisions
Start with more dose options and let the data identify the best treatments.
Fewer Patients, Better Results
Adaptive designs use fewer patients to achieve stronger scientific conclusions.
Flexibility Across Phases
Adaptive and seamless trials are used in every phase, from Phase 1 dose escalation to Phase 4 post-market studies.
An adaptive trial is like driving with your eyes open! It allows the pre-specification of flexible components to the major aspects of the trial, like the treatment arms used (dose, frequency, duration, combinations, etc), the allocation to the different treatment arms, the patient population used, and the sample size. An adaptive design can learn from the accruing data what the better therapeutic doses or arms are, allowing the design to hone in on the best arms. This allows the design to start with a wider range of doses – say 8 instead of 3 – with using a smaller number of patients. The result is a smart design, using resources (including time) much more efficiently, at the same time increasing the scientific precision. Well constructed adaptive designs can be better for all involved – better learning, more efficient, better treatment for subjects in a trial, better information for regulators and the medical community.
The one drawback is that adaptive designs are more work to construct. It involves clinical trial simulation to make sure the design works well, meets regulatory scrutiny and is efficient. Creating an adaptive design means getting all parties involved in the process – having statisticians work with clinicians, marketing, regulatory experts, execution teams, drug supply, etc, to construct a highly efficient design.
Development phases
Adaptive trials are not restricted to phase 1, but rather all stages of development of drugs and devices.
Sample size, Dose escalation, Combination of arms, Seamless phase 1-2.
Sample size, Dose allocation, Introduce/Drop arms, Histology investigation, Prediction of Phase 3, Seamless Phase 2-3.
Sample size, Multiple arms, Accrual Interim Analysis, Futility Analyses, Timing of Conclusions.
Sample size, Timing of Conclusions, Indications
