Clinical Trials

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."

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