Grey's Anatomy Clinical Trial Participation

In the movie, Living Proof, several clinical trials took place to ultimately reach the goal of getting the medical drug Herceptin approved. This particular drug is often referred to as HER2+ (Human Epidermal growth factor Receptor 2 – positive and is typically treated during the early stages of breast cancer in which it has spread to the lymph nodes. A clinical trial is a part of medical research that in such a way attempts to prevent, detect, or treat diseases such as cancers. The clinical trials can range from new drugs being distributed to the market, new surgical procedures, or simply to improve treatments that we now have and use today. Rarely can a single clinical trial establish and assists a medical procedure/drug to become approved.

In a way yes, clinical trials could help the medical world and patients, but are the consequences and side effects of these trials worth the risk? In the article stated above, Netto states although clinical trials are supposed to follow specific guidelines, but “these official guidelines are not binding and enforcement is lax.” This shows that some consequences are not being considered when being acted on. I think the utilitarian would question the idea of are these clinical trials worth potential harm to the people of the society.

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

In the field of medicine, clinical trials are known to be a reliable source of information. Although ethical issues do arise, to which the theory of equipoise was proposed, which states that there should be a balance of forces of interests (Weijer et al., 95). There are two types of equipoise; clinical and theoretical. Clinical equipoise is the assignment of multiple treatments to be tested on patients with the disagreement in the medical community in which medical professionals have differing views that one treatment is better than the others (Weijer et al., pg. 97). Theoretical equipoise is between a physician and researcher and the belief that the risks and benefits of the treatments are in perfect balance (Wiejer et al., 96). The differing factor of the two, being that clinical equipoise focuses on the difference in views of certain treatments involving much of the medical community to form an insightful conclusion on the procedure to which the evidence supporting each treatment does not have to be balanced, whereas theoretical equipoise focuses on the equal amount of risks and benefits within each treatment (Weijer et al., 97). With that being said I personally believe researchers must be in a state of clinical equipoise to run morally acceptable clinical trials.

Additionally human medical research studies often targeted those who came to public teaching institutions desperately seeking free medical treatment and who generally looked up to doctors and experimenters as experts in the field who were there to help them. While this motivation may seem logical, it is often faulty as many human medical research studies throughout history demonstrate that the motivation of medical researches is often not the care of those currently suffering from a particular condition but the future returns on the cures or medical treatments that may be discovered during the study (McKie). As with many such unethical studies, the participants often do not give consent and are not informed of known dangers to the procedure, medications or lack of treatment. The use of individuals who are poor, uneducated, and lack medical insurance in combination with prestigious university research institutions and the white coated, well-educated researchers motivated by discoveries of cures on the scientific frontier results in abuses of individuals.

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 research ethics, especially with the human subjects, is a very complex topic, and the completion of the certification opened my eyes on many aspects of research process. I learned how important it is to fully understand the research purpose and the methodology especially when selecting participants. I learned which populations are considered vulnerable, how to balance risk and potential benefits of research, and the importance of obtaining an informed, voluntary consent. I learned how important it is for researchers to ensure subjects confidentiality and privacy. Hardicre (2014) said that the research would be impossible without volunteers, and that the researchers “must act as patient advocates to ensure that every stage of the research

The report focuses on one particular issue involving the determination and communication of all the “reasonably foreseeable risks” that are associated with participating in a trial compared to receiving standard of care interventions. The OHRP and the U.S. Department of Health and Human Services (HHS) produced a document entitled Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (“Draft Guidance”), so that comments and expert opinions could be gathered on the subject (IOM, 2015). As a result, an IOM sponsored workshop was convened to facilitate dialogue among stakeholders about the ethical issues surrounding study design and informed

(Adams M. , 2013). ?Before a drug is introduced, regulators demand controlled clinical trials (on carefully selected homogeneous samples); but, once a drug is widely in service, they fail to engage in systematic monitoring of what happens in everyday clinical practice, with ?real? patients.? (May, 2004).

Patient also feel that only allowing drugs to be used for clinical trials to encourage greater participation in testing is unfair. Being a part of a drug trial is not easy for patients. Chahal points out that tests are often conducted in major cities, requiring many patients to spend significant amounts of time away from their hometown (368). Leaving home requires extra expenses for travel, lodging, and food and extra emotional strain from being away from family and friends. However, many deem these hardships as necessary for the moment in exchange for the

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

Not only could a complete experimental trial help avoid mistakes based on early promise in a study, there was also the possibility that Mr. Ryan would not benefit from PLX4032, which in effect would have delayed the study as the principals of a randomized controlled trial would have been compromised.

Identifying the reasons leading to participation in clinical studies also ensures researchers are in a position to outline projects that benefit patients as well as predicting eventual barriers that might otherwise constrain their involvement. In this context the paper seeks to reinforce the importance of marketing strategies for recruiting and retaining volunteers as well as gasping the most effective kind of approach (promotional, communicational, economic incentives, among others). This study is based on exploratory research, deploying a deductive method, bailing up statistical methods in order