This paper reviews various aspects of a medical trial study carried out in Japan. The critique evaluates issues of human protection, data collection, analyses and management as well as the final findings. The study by Boulton et al. (2011) highlights the comparative use of dapagliflozin on two treatment groups consisting of diabetics with type II diabetes (T2DM) and healthy subjects. The research paper was published in the fourth issue of the Diabetes, Obesity and Metabolism Journal in 2011. The main objective of the research was to investigate the tolerability and safety of dapagliflozin in the Japanese participants. Evaluated aspects included the pharmacodynamics (PD) and pharmacokinetics (PK) of the drug on both treatment groups. Protection of Human Participants The implicitly implied benefits of this research included the ability to determine the tolerability and safety of the drug for Japanese subjects, and thus offer a reliable, non-insulin dependent therapeutic option for T2DM management. This would be beneficial because it would save patients with T2DM from regular insulin injections and costs if it would be established as an efficient mono-therapy option or improving add-on to other diabetic therapies. The authors of the research recognized drug allergy as a potential risk and possible aggravation of cardiovascular and diabetic ketoacidocis. As such, precautionary measures were taken to exclude subjects with such conditions or a history of such conditions. In addition to the highlighted benefits, the researchers failed to note that dapagliflozin’s effectiveness does not depend on the dysfunction severity of beta cells. Unlike most other therapies, its effectiveness will not decrease with beta cell failure advancement or with higher severity of insulin resistance. This would be a major benefit in the T2DM therapy. Additionally, they also failed to identify other risks such as possible aggravation of polyuria, which may results from the diuretic effect of dapagliflozin. The research was conducted after acquisition of informed consent from subjects as stated within the material and methods section, and as such it is expected that all participants consented to participation after full information. The research process and procedures adhered to GCP (“Good Clinical Practice”), and “Japanese Pharmaceutical Affairs Law” both of which define standards of clinical pharmaceutical trials (Boulton et al. 2011). The adherence to these standards as asserted within the paper implies that indeed the participants must have voluntarily accepted participation in the study. This is because voluntary participation is one of the stipulations under these standards, and adherence confirms willing participation. As part of ensuring adherence the researchers also sought approval from the local ethics committee/ IRB (“Institutional Review Board”). From these facts it can be inferred that ethical, procedural adherence was upheld as required in any drug trial cases. Data Collection Data collection in the study was done through the bio-analytical
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Running Head: Research Critique-Dapagliflozin Trials. Research Critique-Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium–glucose co-transporter type 2, in Japanese subjects without and with type 2diabetes mellitus Name: Institution: Date: Introduction The use of documented research for study and replication purposes is meant to develop knowledge in research and enhance better understanding of how researches are carried out and the procedures undertaken to attain the results (Greenhalgh, 2010)…
The items are grouped into three main domains namely; research team and reflexivity, study design, and data analysis and reporting (Tong A, 2007). This method has been developed following the complexities associated with reporting fundamental aspects of qualitative researches.
Such factors are of major interest to schools of nursing and members of their faculty as they may be able to adjust their curriculum or admission requirements accordingly in order to achieve a higher rate of passing in the examination. Findings of this investigation may also help future test-takers in determining the type of preparatory programs and courses that they should take in order to aid them in succeeding at the examination.
One of the issues that could be inferred from the problem statement is that there exists a significant gap of knowledge regarding the experiences of the night shift nurses as they engage in their occupations (Nilson, Campbell & Anderson, 2008). It would seem that the study sought to explore the assumptions, fallacies, untruths, misconceptions, and ignorance on the facts that relate to the challenge of the ENs and RNs who work during the night shift (Lounsbery, 2007).
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nt to develop knowledge in research and enhance better understanding of how researches are carried out and the procedures undertaken to attain the results (Greenhalgh, 2010). These critical analyses of researches facilitate understanding of how to conduct and replicate
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The content of the abstract is concise but fully explains the issues in the article. It tells that the article consists of an experimental study, the challenges because of which these experiments were done, and the names of authors whose studies are used.
Finally, purchasing groups involves the less stable groups purchasing liability insurance coverage as a block from an insurer.
4. The first question by Koviak (2004) entails the reasons for the current