Essay Double Blind Randomized Controlled Trial

Placebos have been used in clinical trials since the eighteenth century but did not become a research topic until the late twentieth century (van Haselen, 2013). Most often when using placebos in clinical trials it is to determine whether or not the active agent has more effect on a patient than the placebo by providing each to the same number of recipients. The trials are almost always double blinded, this means that both person giving the drug and the person receiving it are unaware whether or not it is active so that good care and relationships must be present in the recipients at all times (Tavel, 2014). Ovosi, Ibrahim, & Bello-Ovosi (2017) declared “The choice between placebo and active controls in clinical trials affects the quality of the result as well as the ethical and scientific acceptability by both the public and regulatory bodies. It has, therefore, continued to generate discuss among researchers” (para. 3). This goes against the autonomy of a patient which is the right for a person to

We are focusing our clinical trial trail phase III study trials in USA, Japan and Germany as we have checked feasibility for those countries for Type II Diabetes Mellitus (T2DM) patients who have been prescribed Kombiglyze XR by their physician for the treatment regime and how it is responsible to induce the heart related diseases. We will conduct Phase 3 clinical trial with time limit of 2 years.

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

Misconception with equipoise will make the barrier between therapeutic and research null. Its goal in producing reliable and generalizable knowledge is coiled in with ethical difficulty. That’s why on an ethical standpoint, benefiting a collective group needs to be weighed with the rights of the participant patients in the clinical research. However, the goal of equipoise is beneficial since its main priority is extracting epistemic information from the randomized clinical trials. The useful information is needed since equipoise follows the principle of having “a state of genuine uncertainty.” This affects both theoretical and clinical. So, trials that are redundant can be marked out by taking equipoise into account since the trials have already been run where there is already certainty of the outcome. So, to detail what equipoise allows underneath the principle of “non-exploitation” is that there will be no exploitation of participants or patients with a needless trial that holds no useful outcome. Equipoise becomes a necessary condition in order for a trial to become ethical since trials must be reviewed to be deemed of value. But, there’s an underlying factor that equipoise’s uncertainty trials do not bring about and that is the health of the patients. Participant patients will undergo trials of uncertainty so there is a possibility that the patient may be harmed during the process. If the trial proceeds, then the health of the patients will be even more at risk, disregarded and exploited in order to grasp epistemic information. The moral principles between medical therapy and those that guide clinical research is different. Though, equipoise is valuable in a collective sense – it is exploitative of participant patients by failing to consider the balance with the subject and societal

Occupational functioning: Rosa isn’t currently employed. She did work as a waitress but she mostly prostituted and sold drugs to bring in the income for her family. For Rosa Lee not having much education she doesn’t have any job perspectives. Due to the lack of knowing how to read, Rosa made money the best way she could.

Double-blind Procedure- An experimental procedure in which both the research participants and he research staff are ignorant (blind) about whether the research participants have received the treatment or a placebo. Commonly used in drug-evaluation studies.

Clinical trials, or a test before a treatment is approved to be safe for human consumption, have been dated back to the biblical times. Recorded in the “Book of Daniel” a king and military leader performed the first known clinical trial (Evolution of Clinical Research). Although his experiment was nowhere near what we conduct in today's society scientist, doctors, and other researchers before them have learned through trial and error, and they have used clinical trials to study diseases. In 1774 James Lind followed through with the first clinical trial of the modern era studying scurvy.

19. The text points out a common misconception about the term “controlled experiment”. In the

The process used to pool the data together was clinical trial decision making. The main factors influencing this process consist of patient, provider, and treatment. Two studies specifically explored decision making by the patient. Education requirements impacted decision making since understanding the risks and benefits of clinical trials was the most important factor taken into consideration by the patient. Educational interventions were noted to have increased patient enrollment. (Biedrzycki, 2010).

The group who took the pill were all the same patients of one doctor with the same problem: aspiring actors with a stutter. The other group given the placebo had a different doctor and they had a speech problem from childhood. It didn't seem like a random assignment. I would like to see what happens if the latter group with childhood speaking problems would have taken the drug. The researchers should have mixed both groups together to make random groups. Random assignment assures that each patient has an equal opportunity to be assigned to either experimental group. This is used in experiments to ensure that differences and similarities between people in the groups don't mess up the results of the experiment. In this study, random assignment was not used. Bias can also be a problem that effects the results. If the researchers already have a bias opinion on what will happen to a certain group when they take the medication then it could easily mess up all the results. Bias is an opinion the researcher or participant may have before the experiment is even conducted and with these preconceived thoughts, it could change the true results. It is a good idea to have a double-blind procedure which is where both the participant and researcher are blind to who is getting the treatment. This helps with any pre-expectations and can help researcher get more accurate results. The results of this

Every day, there are scientist/ researchers conducting experiments, or studies, in order to try and prove facts about everyday life. In conducting these experiments, there are the normal, ethical experiments that have continuously gone to prove many different facts that most of us might have not even noticed about ourselves or one another, and then there are the few experiments that are deemed to be unethical and, although still have shown and proved to us different facts about ourselves, really can not be replicated once again because of the amount of controversy caused by them. The experiments and studies such as the Stanley Milgram Obedience experiment, the Stanford Prison and Guards experiment, the Bystander Effect, the David Reimer

Jona’s definition of identification is that “the most educated and motivated members of society should be the candidates for research, and their agreement must be autonomous and informed to be valid.” He believes that people who are being experimented on should have a better understanding of what exactly is being done as well as all the details behind it. Patients should not be the guinea pigs in these experiments “the most highly motivated, highly educated, and the least captive members of the society” should be the ones who are being experimented on. With any case this is only justifiable if the experiment relates to the disease. The belmont report states that there are three core principles identified, respect for persons, beneficence,

The author believes that biomedical research is the way of better understanding medicine and without randomized clinical trials the field of medicine will have insufficient information. He argues that randomized clinical trials are the most scientifically sound and ethically correct means of evaluating new therapies. The belief of a physician being unethical when running randomized clinical trials is rejected by this article because previous trials on patients can have a better outcome on future patients. This article stresses that randomized clinical trials must be carefully designed that has an intended purpose of gathering data to improve the wellbeing of patients. If the patient is to endure a clinical trial he/she must be properly informed of the risks of the trial and the health of the patient should be high priority. Overall this article explains the importance of randomized clinical trials and debunks the idea of randomized clinical trials as being unethical. This article uses a utilitarian point of view and gives reasons why these trials can be in the best interests for both the patient and society.

Before an investigational study on a new drug may take place, research subjects must submit informed consent and informed of all possible risks and benefits of the therapy. There are four types of phases associated with investigational studies that may occur. Beginning with the first phase, a Phase I study consist of few healthy participants who do not have the disease that the certain drug is said to treat. The purpose of this phase is to determine the optimal dosage range and the pharmacokinetics of the drug and if further testing of the drug is necessary. Vital signs, blood tests, urinary analysis, and other specific monitoring exams are performed. The next phase, Phase II, also involves a relatively small number of participants who this time have the disease that the drug is designed to treat. Participants are closely monitored to determine the effects and adverse

Denis Diderot once said, “There are three principal means of acquiring knowledge... observation of nature, reflection, and experimentation. Observation collects facts; reflection combines them; experimentation verifies the result of that combination.” Denis Diderot discusses the overall way to obtain information. When wanting to know statistics, numerous experiments need to be performed in order to provide accurate results. Through the abundant of experiments performed, human experimentation is one of those tests. Upon hearing the words “human experimentation,” individuals automatically assume grotesque, immoral, and unethical tests being conducted on people. However, this is untrue because experimenting on humans is beneficial to the citizens