A discussion of clinical trial management practices in the United States and Europe.
Written in 2002; 1,495 words; 11 sources; MLA; $ 49.95
Paper Summary:
This paper examines clinical trial management practices and how they vary in the United States and Europe as a result of wide-ranging governmental bodies and regulations. It compares and contrasts the rules of the the Food and Drug Administration (FDA) in the United States and its equivalent in Europe, the European Agency for the Evaluation of Medicinal Products (EMEA). In particular, it provides a brief analysis of several areas involved with oncology clinical trial management in the United States and Europe, including a discussion of medical ethics, the role of the Institutional Review Board in clinical trials, quality of life issues and health economics in oncology studies. It also looks at investigator attitudes towards clinical trials, clinical trial length, compliance and decisions regarding new drug applications (NDAs).
From the Paper:
"Investigator attitudes towards clinical trials vary widely and are often dependent upon the investigator's direct involvement in the clinical trial as well as the balance between routine patient care and clinical trial management. According to Abelson, Welch, and Lynch (86), ?In a trial, the clinician's judgment carries a lot of weight. The U.S. Food and Drug Administration bases approval of drugs upon a clinician's judgment of who should be in the trial, how to categorize adverse events, whether there is a drug interaction and the interpretation of specific parameters. These judgments are critical.? Investigators are ultimately responsible for all areas of the study, from recruitment and participant selection to event reporting and monitoring."
We have thousands of high-quality term papers, research papers, essays, book reports and dissertations on every topic. At AcaDemon, you can download those term papers to help you write yours! You can be sure that the term paper, essay, book report or research paper you download are top-quality, competitively priced and high-level work.
Look for more research papers, essays and book reports on Clinical Trials
If you can't find your topic here, try another search
or try our affordable, unique custom paper alternative
Custom Research Services include:
Papers written from scratch, according to your specifications. Every paper is UNIQUE - Guaranteed
This Free Term Paper Abstract is a part of our Term Paper Library.Here you can purchase research papers, examples of essays, academic dissertations, articles, notes, analytical papers, book reports, stories and poems. We have thousands of persuasive, point-of-view, narrative, critical, compare and contrast and other types of essays in our Library. You can also find here Term papers on "Clinical Trials", Essays on "Clinical Trials", Research papers on "Clinical Trials", Student papers on "Clinical Trials", Book reports on "Clinical Trials", Dissertation on "Clinical Trials", Thesis on "Clinical Trials", Summary of paper on "Clinical Trials", Articles written on "Clinical Trials".
Look for more research papers, essays and book reports on