Program Plan
The purpose of the Program Plan Stop is to create a comprehensive Clinical Development Plan for the Decentralized Trial.
Description
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 Development 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.
DCT-specific Considerations/Inputs
Novel Digital/DHT Endpoint Validation / Partnership Strategy with DHT Partners
Technology and Data Strategy
Collaborate on Regulatory Gaps
Data Connectivity
Reference Documents
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
ViewPatient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
ViewEnhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
ViewDigital Health Technologies for Remote Data Acquisition in Clinical Investigations
ViewBEST (Biomarkers, EndpointS, and other Tools) Resource
ViewACRO’s DCT Toolkit
ViewThe Playbook - Digital Clinical Measures (Digital Medicine [DiMe] Society)
ViewCTTI Digital Health Trials
ViewCTTI Recommendations: Decentralized Clinical Trials
View