Clinical trial

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 that in this phase, the researchers recruit a small group of people who has suffered from the disease which the drug is supposed to effect on. At the end of phase two, the effective dosage and its interval will be determined. In phase three, the researchers…

towards adaptive design in a clinical trial as per the U.S.FDA guidance. The adaptive trial design gives greater benefit compare to the traditional drug trial design for the success of the new drug approval from the pipeline to the patients. The meaning of to accept adaptive trial design is to make clinical trial more efficient by allowing changes in the clinical trials. Adaptive trial design allows researchers modification in the clinical trial and statistical procedure of the clinical trial…

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…

Clinical trials ought to be conducted under calibrated statutory regimes where: 1) There is full disclosure to the patient undergoing the trial. 2) The right to withdraw at any stage without any consequence. 3) Comprehensive medical insurance. 4) Meticulous monitoring after administration of the drug for serious adverse effects. 5) Free access to the drug for the trial participants when it is cleared for commercial use. The bodies responsible for regulation of Clinical Trials are as follows:…

In 1999, the clinical trial of a young man by the name of Jesse Gelsinger ended in tragedy (Archenbach, Joel). Though the clinical trial was conducted responsibly, there was still room for error, or accidents, which both Jesse and the doctors were aware of. They understood and accepted the fact that the trial could have a negative outcome. They were prepared and would not give up and neglect their studies if something went weary. However, this is not the case for Victor Frankenstein and his…

Dr. Brawley’s experience at National Cancer Institute is very eye-opening. I like the story of CD-4 study in the Chapter 15 The Guillain-Barre Syndrome. As a pharmacy student with interest in clinical research, I understand the importance to get the consent of the patients including not only the possible advantages but also the uncertainty of the risks. In this story, an AIDS patient with failure of three courses of therapy eagerly wanted to be enrolled in the CD-4 phase 1 clinical trial…

Primary endpoints are the most important aspect of the clinical trials that help determine their relevance in regards to research and development. It is the outcome by which the effectiveness of treatments in a clinical trial is evaluated. Because of its importance, it is essential for primary endpoints to be concisely and carefully specified to ensure that the results will be accurate and accepted in the scientific community. They must possess important characteristics that ensure qualitative…

pharmaceutical companies have been scrutinized heavily for several years. There appears that pharmaceutical companies are emphasizing more on the drugs fitting scare mongering, as well as problems that are over medicalized. Thorough testing and clinical trials are essential to have medical drugs that are good, but it seems there are several shortcuts that comprise of pressuring to have results which are favorable, carrying tests on people minus their consent, as well as applying drugs for uses…

Phase III Multinational Clinical Trials for Biosimilar USFDA and Health Canada have established exclusive approval pathways for biosimilars, they are not identical copies of their originators but needs to show a highly similar structure and similar clinical efficacy, safety and immunogenicity to their approved reference biologics. The main goal is to approve biosimilars are to reduce the cost and make it available to the large population. Biosimilars also undergo for testing at all stages of…

and senior) in both Gender, Healthy Volunteers accepted. The following Informed Consent has two parts: 1) Information Sheet (detail of research) 2) Certificate of Consent Part one: Information Sheet Please read this form carefully. It gives you the vital data and objectives about the clinical study. An individual from our investigation group will communicate with you about participating in this investigational study. Individuals…