Clinical trials are constantly changing and picking up new ways to achieve better results. One of these is choosing adaptive designs. In clinical trials for Veristat, adaptive designs let the clinical research organization change the way the trial is done as the trial goes on. This modification can be in the patient population. It can also be changed in the trial’s key endpoints. These changes make it possible for the trials to get better results and use less time and money overall.
Some of the best practices for adaptive designs include:
planning and preparation for adaptation
Creating a responsive mode is the best way to make a good adaptive clinical trial. This means you need to plan how your trial will respond to changes as they come such as adopting at home clinical trials in case of a pandemic. This is different from developing a reactive mode, where changes in clinical trials catch you by surprise. You can make these adaptive designs work well by planning for and getting ready for them. This makes the transition phase swift.
Clearly define your hypothesis and endpoints
It is important to define what your endpoints are for the trial clearly. As such, you can easily spot when it is n necessary to modify the trial practices. For example, if your endpoint is to finish the trial in a shorter period, you modify your trials to adopt adaptive designs such as remote trials to help you achieve your goals in the stated period. However, this can only be possible when you clearly define what your endpoints are. In addition, you need to clearly define how adaption and modification will be done in the trial. This helps avoid time lags, and biases, and achieve transparency.
Use simulations to pre-test the trial designs
The clinical trial design must be pre-tested under different scenarios to gauge how they will fair in the main trial. Use different sample sizes and power calculations to find the optimal one for the trial. Pre-testing helps to identify loopholes and potential issues that may arise with the designs. When you identify these issues, you can then take proper measures to mitigate them such as modifying the overall trial practices. Simulations are also helpful when the trial design is complex. It allows for the dissection of the design into different elements helping you to identify the designs and practices that balance feasibility and performance. In the end, simulations help in informed decision-making.
Use data monitoring and independent monitoring committees
Using in-house data monitoring committees (DMC) is beneficial in that it practices timely insight into the trials and their practices. The in-house team can provide fast data review and offer insights and recommendations. As such, an independent (DMC) is required to provide consistent, objective, and unbiased oversight to ensure the trials are conducted safely and ethically. A DMC is also unlikely to be influenced by a conflict of interest because it is not affiliated with the sponsors or other trial parties. This helps to achieve unbiased decision-making. Lastly, a DMC helps to ensure the integrity of the adaptive clinical trial design. This is done through reviews that ensure data is collected, analyzed, and reported transparently.
Adaptive clinical trial designs help maintain the trial’s credibility, performance, and feasibility. However, proper practices such as planning and use of an independent data monitoring committee must be employed for adaptation to be done effectively.
