The use of traditional clinical studies has been brought into question over recent years, due, primarily, to the length of time they take and the high costs associated with them.
A new approach, known as adaptive clinical studies, was developed. It has a number of advantages over old methodologies. as it allows the hypothesis or design to be modified in response to data collected from participants during the study.
There are several different types of adaptive clinical study. These include adaptive randomisation design, a biomarker-adaptive design, an adaptive dose finding design, adaptive phase 1 studies, a hypothesis-adaptive design and many more types.
What is an adaptive clinical study?
Adaptive studies are used in the early stages of drug or treatment development. Since adaptive phase 1 clinical studies offer adaptability based on results, they can increase the speed and reduce the cost of getting the subject to the next stage and eventually to market.
Some people might be concerned that this increase in speed and reduction in cost could lead to safety issues with the studies. However, it has been seen over many years of protocol development for adaptive phase 1 clinical studies that safety is certainly not compromised and could even be enhanced, since the trial can be adapted in response to the data received from patients.
The pros and cons of adaptive clinical studies
As with all new approaches, there are pros and cons. The speed and adaptive nature of the trials allows there to be easy bridges made between the production of medical products and the scientific research behind them. The trials can be fast, flexible and efficient, while maintaining safety standards and the rigorous nature of drug trials.
Adaptive trials do, by nature, require more computer simulation and more meetings of the research panel to be conducted, to ensure the trial is progressing in a useful direction. As they are less uniform and predictable than traditional clinical trials, there is a constant need to review, revise and redesign the study in real time, making for a very reactive process. More details can be found at https://www.jliedu.com/blog/adaptive-design-clinical-trials/.
Overall, adaptive trials are considered to be a great advance in the research and development of drugs and procedures, due to the speed and reduced cost, making the end product more accessible in a shorter time.