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;

•      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.

Financial Disincentives

•      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.

SOURCE: This table is based on comments made by individuals participating in workshop discussions and the presentation of the Discussion Paper: Eisenberg et al, 2012. Developing a Clinical Trials Infrastructure. Discussion Paper, Institute of Medicine. (See Appendix G.)

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