|Challenge||Possible Course of Action|
|Poor communication about trials||
• Develop opportunities for meaningful communication among patients, researchers, and community physicians about clinical trials;
• Provide more information online about trials, perhaps through a user-friendly interface to ClinicalTrials.gov;
• Transparent and reliable communication of trial results to the public through a patient portal; and
• Facilitate remote clinical trial participation through mobile and web-based technologies so that patients do not need to visit research centers or physician offices for recording of progress.
|Regulatory and administrative barriers||
• Standardized contracts to reduce trial start-up delays;
• Online protocol tools and common technical documents for applications to conduct trials;
• Harmonize international requirements for reporting adverse events;
• Creation of a universal numerical scheme to identify clinical trials across the world;
• Build the U.S. regulatory framework for co-development of new drugs and the devices to administer them;
• Harmonize clinical research site inspections;
• Centralized IRBs, and other forms of relief under HHS Common Rule (see text below); and
• More flexible FDA and NIH processes for determining type of trial appropriate for a drug investigation phase or research question.
• Locally adjusted fee schedules for clinical research tasks, to compensate practitioners;
• Private payer support, modeled on Medicare program, to provide “coverage with evidence development” (CED) for novel treatments; and
• Funding support for clinical trials by employers concerned about health care–related costs.