Equipoise clinical research

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

Stephan Bonnar and Josh Barnett , mixed martial arts (MMA) fighters from the UFC and PRIDE Fighting Championships , have also tested positive for the banned substance. [7] After the World Extreme Cagefighting show on January 20, 2006 Muay Thai turned MMA fighter Kit Cope also tested positive for boldenone. [8] Following the Strikeforce card on June 22, 2007 former PRIDE and UFC fighter Phil Baroni tested positive for boldenone, as well as stanozolol . [9] At a K-1 WGP event in Las Vegas on August 17, 2007 two fighters, Rickard Nordstrand and Zabit Samedov , both tested positive for boldenone. [10] Alexandre Franca Nogueira tested positive for boldenone in July 2008. [11]

The responsibilities delegated to steering committees or contract research organizations (CROs) by a manufacturer and/or funding agency can vary considerably. It is important that the responsibilities and authorities of the product manufacturer, the funding organization (if different) and any other entity be clearly defined and understood by all parties at the start of the endeavor. Potential conflicts of interest of each party, especially sponsors and clinical investigators (see 21 CFR Part 54) should be carefully considered when determining roles and responsibilities.

Equipoise clinical research

equipoise clinical research

The responsibilities delegated to steering committees or contract research organizations (CROs) by a manufacturer and/or funding agency can vary considerably. It is important that the responsibilities and authorities of the product manufacturer, the funding organization (if different) and any other entity be clearly defined and understood by all parties at the start of the endeavor. Potential conflicts of interest of each party, especially sponsors and clinical investigators (see 21 CFR Part 54) should be carefully considered when determining roles and responsibilities.

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