Download the Recommendations

In addition to the recommendations, a suite of tools have been developed to assist with implementation:

• Interactive Selection Tool: Excel document for discerning between viable novel endpoints for development
• Flowchart of Steps for Novel Endpoint Development: Flowchart summarizing the process of developing a novel endpoint, generated by mobile technology, for use in clinical trials
• Detailed Description of Steps for Novel Endpoint Development: Table providing a detailed description of the steps for novel endpoint development, including suggested approaches, considerations and links to tangible examples in the use cases
• Quick Reference Guide: Guide to processes for interacting with the FDA regarding novel endpoint development
• PowerPoint Slide of Positive Impacts: Use this ppt slide in your presentations (Note: This information is also included in the first page of the Recommendations.)
• Uses Cases for for developing novel endpoints generated using mobile technology:
  • Diabetes Mellitus
  • Duchenne Muscular Dystrophy
  • Heart Failure
  • Parkinson’s Disease