Adaptive clinical trials are an alternative to traditional trial designs. They aim to deliver a better drug or product in a shorter period of time, while minimising the number of patients who are exposed to the risks of clinical trials. They can be conducted in a wide variety of situations, and are aimed at discovering new treatments. They can also be used to adjust certain parts of a trial design.
The process of developing new treatments is costly and takes a long time. The decision to adapt should be made after a thorough evaluation of the potential benefits and risks. This decision should be based on scientific and ethical reasons. For example, it may be justified to reduce the number of patients in treatment groups with minimal efficacy. It is also possible to increase the chances of finding the correct maximum tolerated dose of a drug. However, implementing adaptive trials requires a great deal of collaboration from research staff and funding agencies.
Using an adaptive design allows for changes to be made as data accumulates. These modifications can be prospectively planned and can help to enhance the power and efficacy of a trial. Typically, an adaptive design combines advanced statistics with interim data analysis to modify an ongoing trial. This approach can improve the probability of finding the correct dose of a drug and can also allow for the discontinuation of a trial early.
While adaptive design can have many advantages, it can create inefficiencies if it is not well planned. A comprehensive analysis plan is crucial. A good preliminary analysis plan should include: a prospective and detailed plan for the initial phases of the trial, the number of interim analyses to be performed, the type of adaptation to be implemented, and the algorithm governing the adaptation decision.
Although a large amount of work is required to implement an adaptive trial, it can be a good alternative to fixed trial designs. It can be very flexible, and can allow for continued additions and deletions of participants as the trial progresses. Find out more about Adaptive Phase 1 Studies by visiting richmondpharmacology.com/specialist-services/adaptive-phase-i-studies
A major advantage of adaptive design is that it can be used to discover new treatments. In fact, the move towards personalised medicine has driven increased interest in adaptive designs.
Adaptive trials are ideal for reducing the number of patients randomised to treatment groups with low efficacy. They are also possible to continue to add and remove treatment arms as the trial progresses. In addition, adaptive designs can be used to evaluate whether enrolling more participants is feasible.
