The NIH has identified multiple roadblocks that impede clinical research or translation of clinical research results into clinical practice. Many translational barriers could be removed or reduced by establishing networks of qualified community-based providers/investigators, called National Clinical Research Associates (NCRA), who are qualified, trained, and eager to initiate research studies quickly, and who will provide community access to studies and their results. NIH has proposed that Research Associate Organizations (RAO) might accelerate and facilitate clinical research by recruiting and maintaining community-based medical practices (CMP). The RAO will train, credential, support, and reimburse the CMPs for their research activities. The investigators propose to conduct pilot studies to develop and evaluate the RAO concept in collaboration with the Community Engagement Resource component of their Clinical and Translational Science Award (CTSA). ? ? Using tools developed by Columbia University's Clinical Research Re-engineering project (supported by a NIH Roadmap Initiative) and the ongoing activities of the CTSA Community Engagement Resource, the investigators will conduct focus groups, time-motion observations, and surveys in four types of CMPs to identify barriers to the conduct of clinical research by different community health care delivery systems. The CMPs include: 1) suburban private medical practice (mostly patients with private insurance), 2) urban private medical practice (mostly patients with Medicaid, 3) large multi-site group practice affiliated with New York-Presbyterian Hospital (mostly patients with Medicaid), and 4) the Columbia Advanced Practice Nurse Associates ambulatory care practice (80% women, mostly with commercial insurance). In future years, they will develop infrastructure to alleviate translational barriers and initiate clinical research in the CMP. ? ? A nationwide network of RAO, centrally coordinated by NIH, could dramatically shorten the time from laboratory innovation to best clinical practices, thus accelerating advances in human health. The same network of RAOs can disseminate study results directly to study participants and also to other community providers, thereby promoting rapid and widespread introduction of new medical findings. The increased efficiency rendered by a nationwide network of RAO would not only accelerate advances in health care, but also decrease the cost of bringing medical research innovation into the mainstream of health care. ? ? ?
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