25 Jan The advantages of adaptive clinical trials
Flexibility has advantages in many walks of life, and this is also true when it comes to clinical trials. The ability to be able to apply a flexible approach and adapt the design of trials accordingly can offer many benefits. Here, we take a brief look at the advantages of such adaptive clinical trials.
What are adaptive clinical trials?
Adaptive clinical trials offer greater flexibility in the trial process by allowing results gathered to modify the direction the trial takes in accordance with pre-agreed rules. One of the key advantages of this approach is that adaptive trials can therefore be more efficient and informative than a traditional fixed approach. They can make more efficient use of resources, such as time and money, and may also mean that fewer people are needed to take part.
The design on an adaptive clinical trial can be applied to any phase of clinical research, from adaptive phase 1 studies right through to confirmatory trials. The British Medical Journal has published a paper on the key design considerations for adaptive clinical trials. However, the pace at which adaptive designs are being used in clinical research has not yet increased.
The reason for this could be that the advantages, limitations and range of trial adaptations are not yet familiar across all of the clinical community. However, there are some industry experts who are now embracing the advantages of adaptive phase 1 studies.
What, when and why to adapt
Clinical trials traditionally follow three clear steps: the trial is designed, conducted and then analysed. All of this is done in accordance with a predetermined plan. It’s a straight-forward approach, but it does not allow for changes that may be needed during the trial process.
An adaptive design could allow for pre-agreed changes to a clinical trial, such as:
– amendments to the sample size
– identifying patients most likely to benefit early on, so that recruitment can focus on them
– changing patient ratios
– stopping an entire trial in its early stages if there are signs of success or lack of efficacy.
Although not a new concept, (adaptive designs in clinical trials have been around for 25 years), they are not yet used widely, despite their many advantages. However, if their advantages outweigh their complexity, surely it’s time the approach was looked at more closely?