Critique - Dapagliflozin Trials - Research Paper Example

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