Equipoise ethics clinical research

The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test . The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated in a given test . But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small. [49]

This Code is intended to be used by ACRP members and Academy Certificants in conjunction with applicable national and international frameworks that govern the practice of clinical research, such as professional license requirements, ethical principles, guidelines, and laws and regulations applicable to clinical research, including, but not limited to, the Declaration of Helsinki, Belmont Report, ICH GCP, US Codes of Federal Regulations, WHO “Ethical Standards and Procedures for Research with Human Beings,” and UK Research Governance Framework. The term “Clinical Research Professional” as used herein encompasses many job titles, disciplines and duties within the profession of clinical research. For the purpose of this Code, the term shall include anyone involved in the design, conduct, reporting, review and oversight of clinical research who is an ACRP member or Academy Certificant or applicant for membership or certification.

​ Elevated blood concentrations of both lactate and lactate clearance rates have been used, with varying success, to predict outcome following trauma, sepsis, and traumatic brain injury (TBI) (Glenn 2003, Nguyen, 2016, Jones, 2010). What complicates the picture is that lactate, which was once thought to be a waste product of metabolism, has now been shown to be taken up by the brain and used as a fuel (Glenn 2003, Glenn 2015). Furthermore, while showing that lactate is an important gluconeogenic substrate following TBI, we have also shown that other compounds such as amino acids will increase during lactate infusion (Glenn, 2014 Wolahan, 2017). This research will occur at two UC level 1 trauma centers, and be a prospective observational study of blood metabolites. Venous samples will be collected 2 times a day for 3 days. The primary endpoints will be lactate concentrations over time. Secondary endpoints will be metabolomics analyses of blood samples and CSF, discharge outcome, GCS at time of blood draw, and microdialysis and CSF glucose and lactate. This study will be the most extensive study of blood metabolites performed to date in critical care patients.   Our aims are to: 1) Determine the time course of lactate blood clearance in TBI patients; 2) Determine a targeted metabolomic profile of blood following traumatic injury; 3) Determine if modeling/multivariate analysis of targeted blood metabolites leads to a better prognostic model of outcome compared to glucose and lactate blood levels alone.

Let ACC help you earn points toward the ABIM’s Maintenance of Certification program AND learn valuable information in the process! ACC’s MOC modules feature ABIM-quality questions that not only allow you to assess your current level of knowledge, but help you learn from a detailed commentary that accompanies each question explaining why the right answer is the best choice, and also why the other answer choices are suboptimal. Our convenient online format allows you to get feedback on each question as you go and submit your scores to the ABIM for MOC credit in just a few easy clicks.

Equipoise ethics clinical research

equipoise ethics clinical research

Let ACC help you earn points toward the ABIM’s Maintenance of Certification program AND learn valuable information in the process! ACC’s MOC modules feature ABIM-quality questions that not only allow you to assess your current level of knowledge, but help you learn from a detailed commentary that accompanies each question explaining why the right answer is the best choice, and also why the other answer choices are suboptimal. Our convenient online format allows you to get feedback on each question as you go and submit your scores to the ABIM for MOC credit in just a few easy clicks.

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