The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications that propose the complete planning, design, and preparation of the documentation necessary for implementation of investigator-initiated clinical trials. The application should propose the developmental work to be performed that would enhance the probability of reaching definitive outcomes in a clinical trial. For more information, visit:  https://grants.nih.gov/grants/guide/pa-files/PAR-17-133.html