STAR-D Case

The first and second cycle of treatments completed under full supervision for observation of responses. Future cycle schedules will change if treatments are interrupted for any reason. After the second cycle, your doctor may adjust the dose of medicine and increase the treatment cycles contingent on the response to bliatumomab. Talk with your doctor to fully understand what’s involved with treatment, the duration and the adjustment of dosage.

Cuijpers (2017) identifies that over the last 40 years there have been approximately 500 randomized trials looking at the efficacy of treating depression with psychological methods. The studies chosen provide insight into the lack of efficacy of antidepressant medication therapy, as well as the effectiveness of psychological therapies. The evidence provided in the studies appears to support one another.

Typically, there is a small number of people used in these Phase I trials, between 20 and 80. Phase II trials have more participants(100-300) who have the condition or disease that the product may be able to treat. Researchers want to gather further safety data and preliminary evidence of the drug’s beneficial effects, and they develop and refine research methods for future trials with this drug. If the drug is indicated to possibly be effective during Phase II, given the observed severity of the disease, the drug will progress to Phase III. In Phase III, the drug is studied in a larger number of people with the disease, between 1,000-3,000 usually. The phase further tests the product’s effectiveness, monitors side effects and, in can compare the product’s effects to a standard treatment, if one is available already. Having more participants reveals the less common side effects. Phase II and Phase III clinical trials typically involve a “control” standard. One group is given the drug and the control group is given either a standard treatment for the illness or a placebo. Phase IV is the part of the trial that is sometimes conducted after a product is already approved and on the market. The purpose is to find out more about the treatment’s long-term risks, optimal use, and benefits, or to test the product in different demographics, such as children. Informed consent is the process by which potential participants for a study are given complete information about the study. The informed consent process provides an opportunity for the researcher and patient to exchange information and ask questions. Patients are invited to enter a trial but are not forced to do so. They can consent to participate if they find the potential risks and benefits acceptable. A participant must sign a consent form prior to enrolling in a study before

Treatments are a long process, depending on what stage you’re in will indicate how long your treatment may take.

In order to identify the challenges with treatment it is worthwhile to list factors studied for predicting treatment outcomes as follows [Ziedonis et al, 2009]

To start out, it is important to differentiate between practice and research, especially in this discussion of therapeutic research trials. Practice is meant to treat an individual in order to improve upon their quality of life. The practice of medicine generally yields good outcomes and is not inherently risky, with some exceptions. However, research on the other hand includes subjects or participants to learn something about people or a topic as a whole. While it seems that the differences are clear, there are many times when the lines between the two may blur. One of the ways that the differences are more ambiguous is in the case of

Treatment was all done similarly regarding to the amount of dosage they used. One of the research was done using a recombinant activated protein C name drotrecogin alfa (DrotAA). Patients were randomly assigned

The trial was conducted for a period in which different levels of dosage was applied to the patients as they enrolled in the health care centers.

The first step in developing a clinical trial is the doctor’s idea for a new treatment. Once it is determined to be scientifically viable and after several committee meetings, a protocol is developed. A protocol is the official playbook or system of rules governing each step of treatment or intervention from beginning to end. The protocol also explains the history of the disease and the treatment drug being used in the trial. Also discussed are the primary endpoint and all endpoints thereafter and lays out the statistical considerations before the trial begins. This is a very intricate part of creating clinical trials

Was your clinical treatment consistent with the best available scientific evidence? Describe why or why not.

These treatments include medications such as, immunosuppressive drugs, steroids, chemotherapy and anti-inflammatory drugs. In addition to medications, therapy and physical exercise can also contribute to decreasing the progression of the disease. Besides medical treatments, there are also a number of alternative methods for treatment, such as mineral supplements, acupuncture, massage and cannabis. Furthermore, clinical trials are also avenues for individuals to explore for treatment. Hematopoietic Stem Cell Transplantation (HSCT) is part of a clinical trial and can be used in conjunction with chemotherapy. An individual named Geoff Flynn traveled to Israel in 2015. Shortly after his treatments, he noticed a decrease in his symptoms and was significantly less fatigued (Fernandes, 2017). Although, his symptoms improved the HSCT treatment is still in a clinical trial period. In addition, the cost of the treatment is significant and most healthcare plans do not cover the cost. Although, aggressive treatments and early detection are key, despite these activities most long-term outcomes are often

Limitations that the paper seemed to have regarding its stance on combined-treatment plans was that the paper specifically states that not all data for certain programs had not yet finished analyzing the data. This calls into question the accuracy of the some of the studies given. Another study that began in 2009 almost collapsed under the weight of its ambition. Hundreds of first-time patients were to be put into two parallel trials. While this was a single mishap, the research paper doesn’t specify it happened anymore before or after. It makes one wonder if not all the tests were handled with the care that such an important test calls for.

Persistent depressive disorder and major depressive disorder are unipolar mood disorders. They are associated with high socio-economic burden, according to estimations cost the US over $200 billion each year (Greenberg et al, 2005 & 2010), and have high suicide rates (Harris and Barraclough, 1998). The prevalence of persistent depressive disorder and major depressive disorder are estimated at 3.6 % and 6.7 % (Waraich et al., 2014). The use of medication and psychotherapy is effective for some patients, yet about 20% of patients do not benefit from any treatment and, for patients that do respond to treatment and intervention, there is a high relapse rate. (Gaynes, 2009). Few pharmaceutical companies are investing in research into

Several stopping criteria have been developed and applied so that a trial can be stopped earlier because either the treatment works or the treatment does not work. They are based on either the posterior density of the response probability, or the predictive distribution of the number of hypothetical responses from m additional patients [Stallard et al., 2001; Tan et al., 2001; Farge, 2002; Zohar and Chevret, 2001; Chen and Chaloner, 2006]. Zohar et al. (2008) listed some stopping criteria as follows:

The consequences of treatment (including side-effects) and of not undergoing treatment (Baur et al., 2010)