Clinical Trial Trail Phase 3 Essay

Phase 3 clinical studies - Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

Type 2 diabetes is considered as the most common form of diabetes affecting many individuals. This is a condition that is associated with a high buildup of sugar content in the blood stream. It is accompanied by symptoms such as constant hunger, fatigue, lack of energy and frequent urination. At milder levels, the symptoms become severe and lead to the death of an individual. In the United States, it has been rated as one of the leading causes of death. Importantly, it also increases the rate of the cardiovascular disease once an individual has been reported to have such symptoms. The cardiovascular diseases lead to a greater rate of complications in patients with type two diabetes and hence loss of life. Due to this reason, researchers have focused more on the development of appropriate drugs to enhance treatment of the condition. Importantly, the fact that it is a big challenge to the medical sector critical evaluation of all possible types of treatment is vital. Therefore, the article on “semaglutide and cardiovascular outcomes in patients with type 2 diabetes” offers beneficial knowledge to the healthcare sector.

Team leadership is a key core competency of the Team STEPPS approach to promoting quality and preventing errors (Clancy & Tornberg, 2007). Team leaders must be adept at motivating, creating a positive environment, assess performance, and creating opportunities for education and skill development (Clancy & Tornberg, 2007). Partnering with a member of senior leadership is an additional strategy for increasing performance and patient safety (AHRQ, 2012). Specific strategies the senior leader can adopt are to meet with the team on a regular basis to identify and remove barriers to project success. They can accomplish this by allocating needed resources, facilitating interdepartmental communication, which increases project awareness and support at the executive level (AHRQ, 2012).

It would also assist to implement an individualised care plan in collaboration with the multidisciplinary team in order to respond the patient’s specific needs accordingly at the organisational level.

The current market for clinical research trials is evolving towards increasing productivity in clinical trials. There is a demand for cost-effective, faster, and more efficient clinical trial processes. Clinician and regulatory agencies are requiring more data from clinical trials, increasing the complexity of clinical trials. Trends towards complex clinical trials have created a demand for increasing clinical trial staffing. In addition, companies aiming for more successful clinical trials have had an impact on staffing. Since 2008,

Type 2 Diabetes is the most common form of diabetes in adults. It accounts for approximately 90%-95% of diagnosed diabetes in adults in the United States (cdc.gov, n.d.). Newly diagnose cases of diabetes tripled from 1980-2011 in the United States. It is a costly and deadly disease. Because there are many comorbidities and complications associated with uncontrolled diabetes, it is essential to treat diabetes effectively. Clinicians deal with this ongoing problem on a daily basis. Therefore, new treatment options are needed. Diabetes can be treated and managed by regular physical activity, healthy eating, and by decreasing cardiovascular disease risk factors, such as high lipid levels, high to decrease blood glucose levels are important aspects of disease management. At this time, there are 14 classes of medications currently available to treat type 2 diabetes mellitus, however, only 36 % of the patients achieve glycemic control on their present medications. Also, the prevalence of type 2 diabetes continues to increase which escalates the medical cost to treat the disease. In 2012, the estimates cost of type 2 diabetes was $176 billion. The cost to treat this disease is going to continue to rise. Even though there are drugs available to treat type 2 diabetes, new treatment options with different mechanisms of action are needed to improve patient outcome through better glycemic control (Miller, Nguyen, Jia-Haur, Chihyi, & Nguyen, 2014).

Now to finally address the experimental issues of this study that the experimenters need to address before their new drug can be put into production and distributed. The first experimental issue of this study was that it did not use random assignment. The participants were placed in either the treatment group or the placebo group by the researcher so they did not have the same chance of

The Project Manager will develop the preliminary budget and timeline based on the detailed project plan. Due to the uncertainties involved with estimating project requirements, management should build flexibility into the schedule. The Project Sponsor will evaluate the analysis results before formally approving the project plan, budget and timeline.

Patients who are eligible for the study and provide written informed consent will randomized to one of two groups, 90 mg dose of Dextromethorphan (twice a day) or the placebo on a 1:1:1 basis. The trial will utilize Clinstat, a free, statistical software, to perform randomization of patients. The random number generation will assign all the participants to the treatment or placebo group by generating a number that corresponds with Dextromethorphan or the placebo. An outside committee that has no interest in the study and is not connected to anyone conducting the study will be responsible for the allocation of participants. This will limit the risk of introducing bias into analyses and results.

The selected trials were analyzed and discussed in each part of the studies to detect any discrepancy, miss information or differences that cause inaccuracy of the research

The team consist of nurses, pharmacist, patient navigators, health educators, data analyst and a network administrator. The team identifies barriers that may prohibit a patient from entering

training leads. The project manager will work with all resources planned and dedicated to this

Signed Protocol and Amendments and Sample Case Report Form 3: Informed Consent Form 4: Any other written information and advertisement for subject recruitment 5: Financial aspects of the trial 6: Insurance Statement 7: Signed Agreement between Investigator and Sponsor 8: Dated documented approvals of Informed Consent Forms, protocol amendments, subject compensation 9: CV and other relevant documents of all the employees and the investigator 10: Normal values and ranges of medical/ laboratory procedures. 11: Samples of labels attached to investigational product containers 12: Shipping records 13: Pre-trial monitoring report 14: Trial initiation report Trial Master File: A standard filing system which contains all essential documents which

The main purpose of a clinical trial is to determine if the treatment is safe and effective for human use, and is required by the Food and Drug Administration (FDA) before a treatment can be approved. There are, however, other reasons these trials are performed. They can be used to compare the new treatment to an already existing one to determine which is more effective, and to determine different ways in which to use current treatments in order for them to be most effective, easiest to use and provide the

This concept was originated from ICH/GCP guidelines of quality control and proper data collection and procedures. Any of these factors can play an enormous role in the success or failure of a clinical trial.