Four Key Principles to Consider When Designing an Adaptive Design Trial

An adaptive clinical trial design allows planned modifications to be made after the trial starts while ensuring the Veristat trial maintains integrity and validity. Clinical research organizations provide flexible trials, leading to more efficient and informative study outcomes. Adaptive clinical trials have been applied extensively in the process of medical device development and are now getting adopted in drug development.

Here are the four principles to consider when designing an adaptive design trial:

Trial planning

Planning the adaptive design trial should be rigorous and include the anticipated number and interim time analysis. It should also include the statistical inferential methods to be used and the type of adaptations. There is a need for a comprehensive analysis plan to be developed before initiating the clinical trial planning. In doing so, you’ll be increasing the confidence that the adaptive decisions are made based on accumulating knowledge and not haphazardly.

Control the chance of erroneous conclusions

A key principle used in an adaptive design is to plan a preliminary test halfway through the trial to find out if the trial meets the efficacy endpoint. Once you achieve the end point early, you will significantly reduce the time and resources required for the trial. If the endpoint is not met, the trial continues with the subsequent tests until the trial is complete. You can always increase the number of tests if the endpoint is not met to increase the error probability in the final analysis. It is therefore important to consider the statistical validity of the final analysis in the prospective planning. Non-adaptive trials have previously relied on statistical theory to ensure that type I and Type II error are completely controlled.

Estimating treatment effects

A potential source of bias in any trial often involves the type of data used in the primary analysis, including populations and endpoints. This often makes interpretation of the treatment effect quite difficult. Methods for correcting estimates to help reduce bias should be planned for and used when reporting the trial results. If such methods are unavailable, it is always crucial to evaluate the extent of the bias, and the treatment estimates should be presented and interpreted with much caution.

Maintain trial conduct and integrity

The knowledge of the accumulation of trial data may affect the course of the trials and the behavior of the sponsor. It is, therefore, important that you limit the access to the interim results to a few individuals independent of those conducting and managing the trials. When planning an adaptive trial, it is important to identify the possible sources and consequences of the trial. Ensure that you plan well to avoid any issues that may arise, including the control blinding and document access throughout the trials. Most of these issues are always similar and impossible to adjust when collecting data.

Adaptive trials often offer more advantages than the traditionally designed clinical trials with more flexibility to make prospective modifications to certain study elements. However, they also have shortcomings, and it is important to ensure that all the study decisions are prospectively specified and carefully considered.