Adaptive designs utilizing techniques like the continual reassessment method (CRM) are increasingly being used for dose-finding studies, due to:
However, when compared to classic designs like the 3+3 clinical staff express the opinion that:
- Superior performance in correctly identifying the right dose
- Less subjects exposed topotentially toxic doses
- Allocation of more patients to desirable doses
- It is difficult to provide feedback during design stage, as it is difficult to translate the theory into decisions
- It could cause delays next doses election, as they would need to wait for the results of the statistical modelsto be run.
This decision tool, helps to solve the two problems above, in the following way:
- During design stage: Our statisticians can provide all possible scenarios for as many Cohorts as the client wishes. This enables the clinical personnel, to understand what the adaptive design would recommend in real practice. In cases where the clinical personnel does not agree with the decisions, additional rules can be setup and the analysis re-run as many times as needed to reach an agreement.
- During dose selection: The decision tool will remain live throughout the study, this enables clinical staff to anticipate the possible scenarios that may be coming and plan without the need to wait for the statistical models to be re-run. Should for any reason clinical decision deviate from the recommendations, the analysis can be re-run on this alternate path and a new plan can be added to the decision tool to help visualize the possible outcomes from this change.
The adaptive design decision tool for dose-finding trials, can be used to utilize the “Dose Transition Pathways” methodology described in Yap et al 2017.
Our adaptive design tool has user access control enabling various layers of security:
A username and password are required by all users to be able to access the tool.
Different permissions levels exist which determine what features users will have access to (e.g. admin user can add and remove team members from accessing the tool,saving diagram states, etc).
Users can traverse the tree by clicking on a node which expands its children. A user with required permission can change drug labels and add comments and dates when a decision is taken. Once a path is identified, the user can choose to only show nodes in this path, and finally export the path to PDF if they wish.
We will be pleased to hear about your trial project and provide you with a tailored-made, cost effective biometrics solution.
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