Equipoise clinical trial

The UG3/UH3 FOA will support applications to implement a multi-site clinical trial of a mind and body intervention (Phase III and beyond).  Under this phased award the UG3 phase supports the planning and development of resources necessary to perform the trial. If the UG3 phase successfully meets all planning milestones, the UH3 phase is awarded to implement the clinical trial. The UG3/UH3 award is used to implement a Clinical Coordinating Center (CCC) for an investigator-initiated multi-site clinical trial of mind and body interventions (efficacy, effectiveness, and pragmatic trials). In addition, multi-site clinical trials require a companion Data Coordinating Center (DCC) application (U24) be submitted with, and linked to the CCC application. Both applications undergo peer review simultaneously. Multi-site clinical trials are defined as trials that enroll from two or more recruitment sites. Multiple sites are necessary to increase generalizability of findings and enhance recruitment efficiency as well as representativeness of the participants. Multi-Site clinical trials are expected to contribute to the evidence base for important health matters of relevance to the research mission of NCCIH. In addition to scientific relevance and excellence, these clinical trials are expected to be conducted with a high degree of efficiency, with streamlined administrative procedures wherever possible.  The Clinical Coordinating Center for Multi-Site Trials FOA runs in parallel with a companion FOA that solicits applications for the companion DCC.  Multi-site trials will be expected to achieve the required phase III trial requirements of NIH (see: https:///glossary   and http:///grants/funding/women_min/guidelines_amended_10_

The Phase II Clinical Trial Award FOA is intended to build upon work that has identified and replicated a biological signature of the a given natural product and complete collections of the necessary preliminary data needed to inform the design of a fully powered multi-site efficacy trial.  Investigators should only apply for the U01 Natural Product Phase II Clinical Trial Cooperative Agreement after they have strong evidence that the proposed biological signature of the natural product can be reliably assessed for a condition of interest in the designated clinical population. It is recognized that for certain conditions (., pain), a direct biological effect or biological signature may not be measurable in human participants for a variety of reasons.  In such instances, a strong justification for why including a biological signature is not possible or impractical with human participants is required. In these cases, investigators should consider including other objective measures that may be a marker of the mechanism of action and provide evidence of a biological or behavioral effect of the natural product in human participants. The U01 clinical trial FOA will support natural product clinical trials (phase II) such as dosing and formulation optimization of the natural product to be used in a future multi-site randomized clinical trial; collecting additional data documenting ability to recruit/accrue participants, achieve adherence to the study protocol, retain participants during study, and complete collection of follow-up data; or determining which patient phenotypes will be likely responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future multi-site efficacy trial.

The most comprehensive classification scheme was published in 1994 by Magerl and associates, whose initial report described 53 distinct fracture patterns. 22 The classification system of Magerl is based on the mechanism of failure of the spinal column and is accepted, with modifications, as a research tool by members of the major spine societies. The main categories in the Magerl system are type A, compression injuries; type B, distraction injuries; and type C, multidirectional torque injuries with translation ( Fig. 318-6 ). 27 These types are ordered in terms of increasing severity of the resultant spinal column injury and subdivided into groups according to the injury mechanism. The division into three groups is based on the morphologic features of the injury and the severity of the injury as it progresses through both the types and the groups, the most stable being an A1 fracture and the least stable being C3. Although the original classification contains further subdivisions, the simplified system reported by Gertzbein stops at the 3-by-3 grid ( Fig. 318-6 ). 27

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    Equipoise clinical trial

    equipoise clinical trial

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