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Program Plan Stop
The purpose of the Program Plan Stop is to create a comprehensive Clinical Development Plan for the Decentralized Trial.
Clinical development program planning is the process of designing and executing clinical trials to assess the safety and efficacy of new drugs and treatments. The clinical program may include several clinical trials across different phases, in different patient populations, with different endpoints. The value of a clinical program plan is to help identify key gates or go / no-go decision points across the molecule's development. Re DCTS: If a new DHT / Digital endpoint is being considered, it is ideally part of the clinical development plan to ensure that all requirements are in place prior to beginning registrational trials for submission to regulatory authorities.
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