Clinical trial protocol

Towering over the tiny five-year-old girl, the enormous principal was wielding a giant wooden paddle. The girl remembered her mother 's words. "You are strong." In the following years and on multiple occasions, the man told the mother that the daughter “would never amount to anything.” These harsh words echoed in my head along with my mother’s voice. Responding with strength and admiration, she said, “We will see. Your judgment cannot break my spirited daughter.” Both comments compelled me…

Introduction These are the models of health such as biomedical and meaning of health are models of health conceptual fame work or ways of thinking about health (the way we think or consider about it.) What is bio-medical? Biomedical model of illness and healing takes a look at the biomedical factors which are things you insert into your body. This could be genetics, food- allergies, and the environment. Repudiate psychological, environment and social influences. And the three health languages…

RWE – For better accessibility of drug treatments Thinking Beyond the Clinical trials Though clinical trials are the gold standard measuring the safety and efficacy of drugs, to evaluate the cost-efficiency of a drug in a real-world environment and measure its impact on quality of healthcare, RCTs need to be supplemented or followed up with the comparatively new standard, called real-world evidence (RWE). Real world evidence has is entering every part of the drug product life cycle from…

publications, around 40–80% of medical information provided by healthcare practitioners is forgotten immediately” (Wasserzuga, Oshri, et. al.). This was proved through a clinical trial that was done to see how much information parents retained after going through the informed consent process for their child. “Based on our clinical experience, we hypothesized that parents do not comprehend all the information that is given to them by the surgeon at the time of the consent process” (Wasserzuga,…

Clopidogrel resistance is associated with great adverse outcomes, early recognition of these patients is very important. However the major problem in this issue is the lack of standardized method and cut-off values in definition of clopidogrel resistance. A few methods have been used but none have been fully standardized or fully agreed upon to measure clopidogrel responsiveness [52]. As discussed above platelet function tests are expensive ,time consuming and complicated , however this…

Sorafenib: Sorafenib is used as targeted therapy for those patients affected by papillary thyroid cancer or medullary thyroid cancer. In a phase III trial, patients were subjected to a double blind, randomized experiment, in which patients were effectively treated with surgery or RAI previously. However, these eligible patients had distant metastatic sites, and were RAI-refractory, which are remnants of cancerous tumors found elsewhere in the body that were not treated in their previous…

1. Describe the clinical trials process of how a drug is approved by the FDA. The clinical trials process can be divided into four phases. Phase one, the researchers recruit a small group of healthy people (20-100 people) into the trial. This phase focuses on absorption, distribution, metabolism and elimination. The small dose will be administered. At the end of phase one, the safe dosage and the best route to administer drug will be set. Phase two is similar to phase one. The difference is…

by another trial with 107 patients, where 31% of the patients had an impartial response, with a median duration for 2 years. Of these responders, 15 responded to the therapy by 8 weeks during the first assessment, 12 had continued responses for minimum of 4 months after ending the therapy, while 17 had responses but left the program unexpectedly. Now, nivolumab use has achieved an improved outcome in patients with melanoma and NSCLC (Mahoney et al. 764-782). Moreover, a Phase III trial was…

evidence and testimony. The Frye Standard and the Daubert Rule have brought new standards in which scientific evidence and expert witness testimony is allowed in court as evidence. When it comes to an expert witness, he or she has to be certified by the trial judge, as well as have the knowledge, education, and experience. An expert witness testimony in a legal proceeding has been the subject of heated debate regarding the fact there have been innumerable instances where scientific evidence has…

The use of biological human tissue is directed by various legal regulations. Understanding these rules and how to obtain meaningful informed consent is essential for researchers and laboratorians to maximize the tissue’s potential for research, to respect the patients’ and subjects’ participation while avoiding lawsuits and destruction to valuable specimens. Regarding laws and regulations (Drabiak-Syed 2010), the Common Rule, included in the Code of Federal Regulations, establishes protection…