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Smart moves start here: problemleads
Despite unprecedented access to digital health data and AI modelling tools, most early-phase clinical trials in drug development stick to outdated, rigid dosing regimens.
The tension lies between the desire to gather reliable efficacy and safety data and the risk of missing 'the right dose for the right patient' due to insufficient adaptation during trials.
This not only leads to higher rates of failures in later trial phases but can also compromise patient safety and mask promising therapeutic effects, leaving clinical and economic value on the table.
Major regulatory hesitancy, integration issues with real-world and historical trial data sources, and scepticism from clinical leads about AI ‘black-box’ recommendations stymie the application of adaptive, data-driven dosing strategies.
Traditional population-based dosing, basic model-informed drug development platforms, and limited use of simple dose escalation schemes.
These do not fully utilize available data or adapt in real time, often leading to suboptimal results.
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This report has been prepared for informational purposes only and does not constitute financial research, investment advice, or a recommendation to invest funds in any way. The information presented herein does not take into account the specific objectives, financial situation, or needs of any particular individual or entity. No warranty, express or implied, is made regarding the accuracy, completeness, or reliability of the information provided herein. The preparation of this report does not involve access to non-public or confidential data and does not claim to represent all relevant information on the problem or potential solution to it contemplated herein.
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