Randomized Controlled Trials

The following ssion of this assignment attempts to critically appraise the venUS III randomised control trial (RTC) published in the British Medical Journal.

However, when they conducted their experiments they did not breach any ethical guidelines since they did not exist (Matta, 2014). Hence, to protect the welfare, rights, dignity, and mental health of the participants, strict ethical guidelines were introduced in psychological experiments which have positively influenced the field of psychology. Also, due to ethical frameworks, people are viewed as ‘participants’ of a study instead of ‘subjects’ in an experiment. They also make psychological experiments more reputable, leading to an increase in the willingness of participation by people as their safety is ensured. The increased willingness of participation is beneficial in order to discover more about human behaviour, the effectiveness of treatment, mechanisms of a psychiatric disorder etc.

There has been an ongoing debate on whether psychology is indeed scientific, although recent, psychology is now considered a science. This is because it uses scientific methodology in researching, devising treatments and measuring the outcomes. These methods include collecting and analysing data and concluding their findings in order to identify whether the research or treatment adequality solves the problem. Scientific studies must be replicable, this means the if repeated exactly the same, the results should produce an identical outcome. Replicability can be increased by ruling out any alternatives that may not have originally been thought of. Objectivity in science is the idea that scientist, in an attempt to get the best results, must first

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

Write a three- to four-page article review in which you discuss methodological issues unique to psychological research and analyze basic

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.

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 data was analysed by a computer program, which was identified but not clarified the reason used. Polit and Beck (2006) argue researchers should clarify that the chosen instrument is the most appropriate for their study with evidence of validity and reliability. Futhermore if an established computer program that has already has established validity and reliability is used this should be outlined as stated by Wood et al, (2006) and in this case were not.

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

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.

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

The study will be separated into two groups, one will be the experimental group that will receive the intervention while the control group will receive pain medication. The intervention that the

This measure is a reliable indicator of trial quality and is based on each trial’s reporting and quality of randomisation and blinding attribution (CASP 2006).

There are six methods used to analyse trial design; of which are discussed as follows.

It is now accepted worldwide that before a drug is brought into routine use its efficacy, safety, and the balance between two need to be formally demonstrated. The efficacy of new drugs nowadays is almost invariably established with a technique known as ‘randomized controlled trial’.