4 Key Considerations for Adaptive Oncology Clinical Trial Design

A Guide to Phase 1 Clinical Trial Designs

Veristat adaptive oncology trial design involves clinical trials that evaluate treatment or a medical device by observing a patient on a specific schedule while modifying different parameters of trials based on the observations. Adaptive designs reduce the number of patients in a trial and provide informative trial results. They are pretty flexible hence their acceptability to stakeholders. Adaptive oncology clinical trials are pretty helpful for clinical safety and efficacy trials. Also, they are ideal for the early phases of a study and the later trials conducted to satisfy post-market commitments. However, the critical considerations for adaptive oncology designs before the adaptive trials are highlighted. These include;

Trial planning

An oncology clinical trial calls for rigorous planning before it starts. The planning must include the anticipated numbers and timing of the interim analysis, the statistical inferential methods used, the type of adaptations, the oncology clinical trial design, and the algorithm that governs the adoption decision. A comprehensive plan analysis before starting a trial increases the confidence in the adaptive decisions made during the trial. It also ensures that the findings are not made unexpectedly.

Estimate the treatment effects

During the study, a potential source of bias is the changes made on the data produced in the primary analysis. This makes interpreting the effects of the treatment quite tricky. Consider methods for adjusting estimates that reduce bias if they are available. These methods should be used to plan prospectively and used while reporting the results. Where these methods are not available, evaluate the minimum extent of bias, and treatment effect estimates should always be presented and interpreted with appropriate caution.

Control the chances of erroneous conclusions

Planning a preliminary is an adaptive design strategy. The preliminaries are tests conducted halfway through the trial to establish the efficacy of the endpoint. Achieving the endpoint early on in the trial can save time and resources. When the halfway test is conducted and the endpoint is not reached, the trials continue following a subsequent test when the trial is complete. The number of tests increases the error probability during the final analysis. The potential statistical validity should always be considered during the prospective planning

The challenges of adaptive clinical trial designs

It would help to consider the limitations of choosing an adaptive design for your trials. While using an adaptive design, the number of trials may be reduced, but you might also miss some critical insights during the interim analysis. After an exploratory study, some insight from a trial might only be captured through thoughtful analysis. An adaptive design might also lead to inadequate recognition of safety issues and other critical information related to the treatment responses and interactions with concomitant therapies. These oversights might be very costly for a clinical trial. Adaptive designs work best when few risks are involved—the fewer the risks, the less time the trial will take.

Adaptive oncology clinical trials offer many advantages compared to non-adaptive trial designs. However, they also come with risks that you must consider during the initial trial planning phase.

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