<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 4 of 11) Agrawal, M. and E. J. Emanuel (2003). "Ethics of Phase 1 Oncology Studies: Reexamining the Arguments and Data." JAMA 290(8): 1075-1082.      This is an important review of the literature evaluating Phase 1 clinical oncology trials to see whether the claims that the risk-benefit ratio is poor, the degree of understanding of the procedures is deficient and that coercion is routine are correct. They show that on balance, patients do a little bit better than expected, so benefits occur, that they understand what they are getting in to and finally that people with advanced cancer are willing to take risks for a possibility of improvement or cure. The lessons are to avoid underestimating the research participant. They may not know everything but they have a pretty good idea of what's important to them. Antman, K., S. Lagakos, et al. (2001). "Designing and Funding Clinical Trials of Novel Therapies." N Engl J Med 344(10): 762-763.       This well-written article discusses the difficulties and importance of funding large-scale studies. Because larger trials have a greater chance of proving statistical significance, lack of subjects is a hindrance to study design. They suggest using a small percentage of health insurance premiums to fund the NIH and increase the scope of all studies. Bailar, J. C., III (2001). "The Powerful Placebo and the Wizard of Oz." N Engl J Med 344(21): 1630-1632.       The placebo is an unchallenged staple of study design necessary to determine efficacy. While it contrasts a treated group of subjects, it does not distinguish between the natural course of disease and the "placebo effect." This article shows that a placebo has no benefit over nontreatment and may actually harm the doctor-patient by exposing patients to deception. Benson, K. and A. J. Hartz (2000). "A Comparison of Observational Studies and Randomized, Controlled Trials." N Engl J Med 342(25): 1878-1886.       In our enthusiasm for randomized clinical trials, we tend to relegate observational studies to a lower level of scientific validity, especially because it is believed that the effects are generally larger in the observational studies. These investigators did a combined meta-analysis of observational clinical trials comparing two agents for the treatment of a condition and found randomized trials that compared the same treatments for the same conditions. They found 136 reports on 19 conditions that fulfilled the requirements. In only 2 of the 19 studies did the results of one method lie outside of t the 95% confidence limits of the other. They conclude that there is no evidence in studies since 1985 for a systematic difference in outcome between the two modes of study. Brody, J. (2002). Ferreting for Facts in the Realm of Clinical Trials. The New York Times. October 15, 2002.       A short article stressing participation in clinical trials for novel treatments. Useful for beginning readers but offers no analysis of study design. Concato, J. S., N; Horowitz, R. (2000). "Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs." N Engl J Med 342(25): 1887-92.       This paper challenges the assumption that observational (case-control) studies overestimate efficacy of treatment. By analyzing corresponding confidence intervals of five topics, it raises questions about trial design and the need for randomized, controlled trials. Davis, M. M. and J. D. Lantos (2000). "Ethical Considerations in the Public Policy Laboratory." JAMA 284(1): 85-87.       Vulnerable populations necessitate the most amount of protection from negative interests and influences. The paper examines how negative incentives are used to encourage immunization in children and the ethics behind public policy trial design. Do they need as much stringency as clinical trials? << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 3 Quick Links Ethics and Study Design Introductory Ethics Design Appropriate Risk to Benefit Ratio Selection of Subject Populations Cases Bibliography Chapter 3 Download (PDF)