Bench trial

them to select from options that already exist. The agency did not think about what the next step after accomplishing the creation of the drug and the approval of the FDA. Doug Reynolds and Becky teamed up because of her mastery in leading clinical trials and reacting to FDA request (Johnston, and Marshall, 2009), needed to move rapidly in making a sales…

Particular scholars have proposed prisoners should be the target group for researchers to enroll in human clinical trials. Using prisoners has the potential to be a more efficient way of conducting clinical trials versus using only volunteers to research and develop useful drugs or treatments. One explanation for this is that conducting efforts to recruit volunteers, screening them, determining if they are healthy enough to continue through the entire research study, and having a readily…

As the use of placebos increases, so does the debate over the ethicality of switching oblivious patients’ medications with placebos. A wide variety of doctors believe the switch is completely ethical and helpful, especially when confronting the opioid epidemic, while others claim “it is unethical to deceive patients by prescribing fake treatments,” (Marchant) especially when it can negatively impact a doctor-patient relationship if the patient is unaware. When my mother’s friend a simple,…

The Scopes Trial of 1925 shed light on teaching restrictions in a Tennessee high school. The trial symbolizes the conflict between science and theology while also leading to the repeal of the Tennessee state law which made the teaching of evolution illegal in schools (“The Scopes Trial”). This conflict between religion and science exists as a recurring controversy in not only history but in Yann Martel’s novel Life of Pi. In the first part of the novel, Piscine Patel, the protagonist, shares his…

The Scopes trial took place in Tennessee centered around a teacher named John Scopes, who was arrested for violating a state law that prohibited the teaching of Charles Darwin’s theory of evolution. The trial immediately attracted two different groups to the case, the Fundamentalist Christians and the religious modernists. The tension was already growing between these two trending groups in America and the Scopes trial was one of the cases that brought this tension to the spotlight. During this…

Clinical Trial Team Structure Strategies Demands of industry and regulators for an improved clinical research landscape include quality by design concepts and increased efficiencies. Teams developing clinical research trials must be strategic to meet these demands and discover future innovations. Team structure must adapt to successfully implement a risk-based approach to trial execution. Team structures should become flexible and collaborative. Additional roles must be included on a…

First CLAS Standard selected: Which standard have you selected? What is the definition of the standard in your own words? What is the purpose of the standard, what does it do, how does it promote culturally and linguistically appropriate services, etc.? The first standard I have chosen is providing effective, equitable, understandable and respectful quality care and services that are responsive to diverse cultural health beliefs and practices, preferred languages, health literacy and other…

manufacturing standards of the drug, there is also the general population healthcare requisite which needs to be met with the limited resources and technology available. For a new drug to reach the market, it takes more than a decade and several tests and trials that the FDA needs to clear. The information for the pre-clinical testing and the new molecular entity (NME) is submitted by a New Investigational Drug (IND) document to the FDA and if approved, it moves to the clinical phases. There…

The Scopes “Monkey Trial” was one of the most famous battles in history between evolution and creationism. After the Butler Act was passed, which banned the teaching of evolution, The American Civil Liberties Union (ACLU) announced it would defend anyone who challenged it. John Thomas Scopes was a teacher in Dayton, Tennessee, who was charged on May 5, 1925 for violating Tennessee's Butler Act. This case pitted two titans against each other, William Jennings Bryan, a former presidential…

Master’s degree in Clinical Trial. I became interested in Clinical Trials after noticing the importance of clinical research. The initial interest developed when I started working at clinical research organization at the administration office. Many new things I got to know from the first months of working there. I became motivated from reading articles and learning new things from my colleagues. We are in an era of specialty pharmaceuticals – new drugs and clinical trials have not only…