Abstract
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."

Tags:fda, nda, oncology, emea

Abstract
This paper examines whether it is ethical to withhold known beneficial treatments to give patients placebos as controls when testing new drugs.

From the Paper
"Whenever clinical trials are conducted on patients, it is necessary to have some kind of control group with which to compare the treatment drug under study. This always presents an ethical dilemma in medicine because if a treatment or drug is withheld from one group of patients, then their condition may worsen and it is questionable whether or not this is ethical if the treatment drug would be beneficial to such patients. Such a dilemma was brought to light in the testing of a new cancer treatment..."

Tags:ethics, placebo-controlled trials, drugs

Abstract
In support of the use of placebo-controlled clinical trials studies for the benefits of AZT (Azidothymidine) for HIV will be used as an example. AZT is a common drug that has benefited from placebo-controlled clinical trials. AZT has been confirmed to prolong the lives of HIV/AODS infected patients by placebo-controlled clinical trials. HIV is a serious medical condition which depends on active treatment for remission. Being without active treatment during enrolment in a placebo-controlled clinical trial puts the patient at risk. As long as strict adherence is maintained in following the Declaration of Helsinki ethical principles the decision of the patient to enter into the trial is not up for ethical debate. The patient has a right to make choices regarding their treatment (Sugarman, 2004, p. 29-35; Lin, et al., 2002, p. 739-741).

From the Paper
Running Head: ETHICAL PLACEBO CONTROL TRIALS A'A Ethics can be Upheld in Placebo Control Trails Placebo Control Trial YOUR NAME YOUR UNIVERSITY ABSTRACT Over the past decade or so researchers have argued that placebo controlled trials are unethical. These types of trials are deemed unethical when there is a known effective therapy available to the patient for the

Tags:placebo, controlled, trial

Abstract
In recent years, HIV has begun to move away from being an automatic death sentence and toward the status of being a chronic, but manageable illness. This paper presents an examination of HIV vaccine clinical trials and examines whether or not minorities are comfortable participating in them. The writer examines the historic Tuskegee syphilis trial and applies some of the problems there to the current hesitancy by minorities to participate in HIV vaccines clinical trials. The paper is based on a literature review.

From the Paper
"The medical community has a documented lack of minority volunteers willing to participate in clinical trials for HIV medications and other treatments. There are several factors that contribute to this trend including a basic mistrust that the minority will be given a fair amount of the treatment in question, as well as historic problems with medical trials and minorities in the past.
(Timeline http://www.cdc.gov/nchstp/od/tuskegee/time.htm)
The need to recruit minority participants for clinical trials is obvious. Minority people get ill and they get disorders. They are part of the population that the medical community is attempting to assist and their participation in clinical trials can help that process move more quickly and efficiently."

Tags:African-American, AIDS, transmission, HBCU

Abstract
While Weight Watchers is not a program that is suitable to every person's lifestyle, it promotes healthy overall change to aid in weight loss. Although little evidence suggests that members successfully maintain this new lifestyle after leaving the program, many members remain members for a significant period, which might ensure that they receive the health benefits of weight loss for that extended amount of time. Although more evidence needs to be obtained on its overall efficacy, it is apparent that Weight Watchers does provide some benefit to its clients. w

From the Paper
Weight Management and Weight Watchers: Its Efficacy and Clinical Trials Americans are overweight. Despite the desirability of youth and of a thin body in American culture and despite the large number of diets available for the average American to use, the aging American population struggles with its weight. In part, diet and exercise are behind this struggle. Fast food is readily available, while the lifestyle of the average citizen is too sedentary to maintain healthy habits. Approximately 40 years ago, Weight Watchers, Inc. came into existence in an effort to combat the effects of lifestyle changes in the United States.

Tags:diet, weight, obesity

Abstract
This paper consists of both an outline and a term paper on investigator fraud in conducting clinical research trials for new drug therapies or other forms of medical treatment. The paper details a literature review including perspectives from the FDA, IRB, investigators not involved in fraud, and sponsors of trials as well as solutions for stopping fraud from each of these 4 groups.

From the Paper
"Fraud committed by investigators conducting clinical trials for new medical treatments can be an extremely dangerous problem. The repercussions of investigator fraud can have-wide ranging implications for the researchers and participants directly involved, as well as those investigators, sponsors, and review boards that propose and develop future research trials. The falsification of data about the treatment and/or the trial can bring physical and psychological harm to the human participants of the research, compromise the trustworthiness of other scientific..."

Tags:fraud, clinical research, responsibility

Abstract
The problem of alcoholism is viewed as a major social problem, one that has an impact not only on the individual affected and not only on his or her family but on society as a whole. Alcoholism has been examined from a number of different perspectives in an attempt to explain its etiology or its consequences

From the Paper
"The problem of alcoholism is viewed as a major social problem, one that has an impact not only on the individual affected and not only on his or her family but on society as a whole. Alcoholism has been examined from a number of different perspectives in an attempt to explain its etiology or its consequences. The prevailing perspective is the medical model, which holds that alcoholism is a disease, which also means that it can be treated through medical means. Alcoholics Anonymous (AA) is an organization that makes use of a theory of self-help to enable alcoholics to take control of their own lives and to learn to change their behavior, following a disease theory of alcoholism. Alcoholics Anonymous stands outside the medical model in that it does not offer a "cure" and indeed holds that the individual will always be an alcoholic. What the alcoholic..."

Abstract
This paper discusses the ethics of the clinicians and the ethics of the participants. Additionally, the paper also discusses patient consent with regard to lower income, low literacy, and non-English speaking individuals. The paper concludes that study candidates should be honest and forthcoming when agreeing to participate, physicians should not be involved for their own glory and the clinical workers should remember that people are not just guinea pigs.

Outline:
Clinicians and Paid Participants
Informed Consent
Benefits of Clinical and Drug Trials
Conclusion

From the Paper
"Every year, hundreds and even thousands of people loan their bodies and their health to be part of paid clinical trials. Some are desperate to help find the cures for cancer, Parkinson's disease, and Alzheimer's disease, or Lou Gehrig's disease, and some are looking for a way to make a few extra dollars. Unfortunately, some people are willing to become professional lab rats, travelling from study to study. The results of these clinical trials can then become skewed because the participants do not disclose that they are participating in a different study somewhere else."

Tags:informed, consent, FDA, regulation

Abstract
This paper describes work carried out by researchers, Debora Spar and Adam Day, with regard to a clinical test of an experimental drug, Trovan, conducted in a Third World country under suspect conditions, with shoddy supervision and for questionable reasons. The paper relates that, though the Trovan trial was perhaps exceptional, it is also considered an example of what can happen when pharmaceutical corporations conduct research on humans in poor countries with bad supervision.

Outline:
Introduction
Background
Analysis
Operational Analysis
Strategic Analysis
Recommendations
Conclusion
References

From the Paper
"A nervous system infection, Meningitis can kill a child in a matter of hours if left untreated. It killed more than 12,000 children in six months in and around Kano, a mostly Muslim city. Pfizer, a pharmaceutical giant drug company saw this scenario as an opportunity to do clinical research on 200 live humans, while possibly helping sick people. Half of the 200 children received Trovan and the other half received a "proven meningitis treatment," ceftriaxone, though they administered a dose lower than recommended. Pfizer has maintained its records demonstrate that not one of the deaths could be linked to Trovan or to substandard treatment, and that the clinical study shows there is a better survival rate for patients on Trovan than for patients who receive the standard drug. Survivors sometimes sustain brain damage or other complications from the disease, even if they are "cured" (AP, p. 1)."

Tags:consent, lawsuit, damage

Abstract
This paper presents an overview of research design for a controlled clinical trial of an experimental drug for patients with Alzheimer's Disease. The paper identifies ethical concerns, variables and the subject selection.

From the Paper
"To test the efficacy of an experimental drug called Physostigmine in delaying the progress of Alzheimer's Disease, a prospective controlled randomized trial is proposed. This particular drug, the independent variable along with a placebo is associated with enhancing acetylcholine levels in the brain by cutting back on production of an enzyme acetylcholines-terase associated with the mental psychological and physiological decline experienced by Alzheimer's victims. The dependent variable in the study is the progression of the deterioration associated with Alzheimer's disease working in conjunction with local..."

Tags:research design, clinical trial, Alzheimer's Disease, drug