Re-Engineering the Clinical Research Enterprise

Lds Hospital, Salt Lake City UT

Investigators

Linked publications, trials & patents

Abstract

We will engage 24 clinical sites in 4 study activities. Sites include academic, community, pediatric, adult (including geriatric), US and Canadian hospitals. Some sites are deeply invested in research and electronic infrastructure and others are exclusively clinical care sites with almost no such investment. This large number of diverse sites has been expressly chosen to provide a highly credible test of feasibility. The diverse sites will provide a fund of participating investigators and hospitals ready to move directly to a large randomized clinical trial with linked research networks. Investigators will participate in one or more of 4 activities. 1 - all investigators will contribute to the general work that includes planning and development of the proposed protocol and network linking strategies, organizational elements, monthly conference calls and twice yearly meetings in Salt Lake City. They will conduct literature research, writing, evaluate documents, and develop strategies to link the pediatric PALISI and the adult NIH/NHLBI ARDS Networks; 2 - eight selected sites will refine and establish safety of a common bedside computerized blood glucose protocol for adult and pediatric ICA patients; 3 - seven other selected sites will subsequently implement and use at the bedside these safe refined protocols for patient care; and, finally, three other selected sites will implement and use computerized Clinical Coordinator tools to aid conduct of clinical studies already under way and independently funded. These three different feasibility tests of the common electronic tools (refinement of bedside protocol, use of bedside protocol in patient care, and use of the Clinical Coordinator program) for multiple purposes in disparate clinical settings should provide a credible and definitive evaluation of the feasibility of our proposed approach. We believe the likelihood of success is high and that this feasibility work and the large number of participants will prepare us to move directly to link research networks and introduce efficient ICU clinical trials on a large scale.