Two completely different viewpoints of randomized clinical trials are given, article one is against the idea and article two is for it. Article one argues that when a patient sees a physician; the physician has the duty to provide the best treatment for that
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
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).
There are many versions of the hierarchical evidence levels. When deciding on basing clinical interventions on evidence, there are two specific models to look at. They both describe levels of evidence and are depicted as pyramids. The first is the 6S model, with the “more patient-specific” information listed at the top of the pyramid (Houser, 2015). The top of the pyramid has the least amount of information as compared to the base, it is more relevant, but it yields the least amount of information (2015). Conversely, the more abundant information found at the bottom is less relevant to the specific intervention in question (2015). Also, the searches conducted at the more basic levels typically take less time to yield results due to the broader relationship to the intervention in question (2015). The 6S model of hierarchical pyramid of evidence are listed as follows from highest to lowest:
The trial involved four different treatment levels, and patients were encouraged to enter the next level of treatment if they failed to achieve remission or response (50% reduction in symptoms) after a specified number of
Treatment effectiveness has been defined as a clinically significant benefit to the patient, with the objective of the patient living for longer or better, or both, than if they did not receive the treatment (Wilson et.al., 2015). This measure of efficacy might be shown by symptomatic improvement, or improvement in established disease progression endpoints (Wilson et.al., 2015). Since clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics, the characteristics of the disease and
Third, professionals who are given new, unusual, and unfamiliar situations may have trouble with accessing and retrieving new evidence (Rousseau & Gunia, 2016). Among these main issues, other criticisms that have arose since its beginning include the effectiveness of treatments and evidence. The first criticism states that evidence-based practice has only one approach, which is only one approach for all people. This is an error within itself and in practice because not all people have the same illnesses and not all people respond to one treatment in the same way (Rousseau & Gunia, 2016). Another criticism is that the practice mainly relies on randomly controlled trials (RCTs), which involves randomly allocating one or other of the different treatments under study. This may affect the patient solemnly on the fact the patient may be receiving only one form of treatment that may increase or decrease effectiveness against their illness, or may be receiving a treatment that has not fully researched and may be excessively failing (Rousseau & Gunia, 2016). Evidence-based practice may also rely heavily on human judgement, which may affect a practitioner 's decision on what type of evidence to use before conducting practice on a patient. Their judgement may not be very stable and acceptable, thus causing various problems in their practice and
Most of the literature is made up of low quality retrospective non-randomised cohort studies with small sample sizes. Ultimately, large multi-centred, adequately powered, well-designed randomised trials are needed to establish clearer guidelines for the management of these patients.
The people in the studies must also be randomly assigned a "treatment" or a "placebo" (Kishita & Laidlaw, 2017, p.126) After these criteria were applied, the number of studies decreased to "15" (Kishita & Laidlaw, 2017, p.127). Information on "participants' age range and mean age, the type of treatment condition, the type of control condition, format of the therapy, the number of sessions, the primary outcome measure,the type of analyses, and means,standard deviations, and sample size for the primary outcome measure in each condition" was recorded for each study (Kishita & Laidlaw, 2017, p.127)
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
Randomized clinical trial (RCT) is the most effective way of conducting research on the efficacy and safety of newly developed drugs and medical treatment for public consumption. Like most experiments, there are usually two groups in conducting an RCT: the placebo group and experimental group. In the placebo group, the subjects receive a placebo drug or a drug that is already available and is used to treat a particular disease and in the treatment group, the subject receives the newly developed drug or treatment. However, in the RCT, the subjects that agreed to participate in the clinical trial are randomly assigned in either placebo or experimental group in order to eliminate observer bias and distribute the subjects’ variables evenly on all groups. Furthermore, RCT is either single-blinded or double-blinded. In single blinded RCT, the subjects cannot know if they are placed on placebo or experiment group. Moreover, the subject cannot know anything about the progress of the trial. As for the double-blinded RCT, both the subject and the physician-scientists who are conducting the trial do not know which subject are in which group and whether a particular treatment’s progress.
The greatest moral objection to the RCTs is that a physician has a duty to their patient to give them the best treatment possible. However, the physician does not truly know which drug is going to be better when they initiate the trial. During the trial, neither treatment is preferred over the other. This is an example of “individual equipoise” is the requirement that “investigator” him or herself be in a state of genuine uncertainty concerning the efficacy of treatments A and B. In clinical equipoise, there is a genuine uncertainty within the medical community about the merits of both treatments. Among physicians, there are some who may believe that a certain alternative treatment option is the best. However, even though there is a physician
The prior study based the design protocol and the variable of diagnoses on limited data. Each of the represented modules of treatment integrated for the study were layered to improve the statistical collection of program performance.
Genuine clinical treatments must exist in balance when weigh against one another (Truog et al. 1999). That this is trying to explain is that when in a trial you cannot have a treatment that has more risks or wait time compared to an alternative treatment. For example, if treatment one has larger risks and a longer recovery time compared to treatment two, which has fewer risks and a short recovery time, then the treatments are not balanced. In this example treatment one and two have the same over all out come, but since treatments are not balanced the patient must give informed consent before undergoing any treatment.