<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 6 of 11) Lilford, R. J. (2003). "Ethics of clinical trials from a Bayesian and decision analytic perspective: whose equipoise is it anyway?" BMJ 326(7396): 980-981.      This important paper recognizes that preclinical and other data tend to increase the likelihood of a trial being successful and that standard statistics, especially in relation to determination whether there is equipoise between the treatment arms is inappropriate. Optimism is not necessarily inappropriate. Marquis, D. (1999). "How to Resolve an Ethical Dilemma Concerning Randomized Clinical Trials." N Engl J Med 341(9): 691-693.       An inherent dilemma exists in physicians recommending standard treatment over an unproven clinical trial. Physicians do not want to be responsible for referring their patients to failed trials, therefore they negate enrollment when giving advice to patients. The paper offers a strong recommendation that emphasizes informed consent as the vehicle to overcome this dilemma. Marshall, E. (1998). "Controversial Trial Offers Hopeful Result." Science 279: 1299.       This article sheds light on a very controversial study testing the efficacy of a new AZT regimen in reducing in utero AIDS transmission. Researchers gave half the subjects a placebo, significantly increasing the statistical power of their study; however, this knowingly doubled their risk of transmitting the virus. Should long-term prevention be sacrificed to ensure greater subject protection? Miller, F. G. and H. Brody (2003). "A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials." The Hastings Center Report 33(3): 19-28.       A predominant ethical view holds that physician-investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second-rate treatments, the experimental intervention and the bet proven therapy should appear equally effective. "Clinical equipoise" is necessary, but this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned. Moynihan, R., L. Bero, et al. (2000). "Coverage by the News Media of the Benefits and Risks of Medications." N Eng J Med 342(22): 1645-1650.       This study of newspaper and TV stories covering three drugs, pravastatin, alendronate and aspirin demonstrated that the information was usually incomplete about the benefits, risks and especially the costs of the treatment. Of greater concern was that the interviewed and quoted "experts" without indicating their ties to the manufacturer of the drug. I must say, the results are not surprising as drug companies are major advertisers and were determined to spin their drugs to best advantage. Nathan, D. and D. Weatherall (2002). "Academic freedom in clinical research." N Engl J Med 347(17): 1368-71.       The article examines the Olivieri debacle that stemmed from cessation of the deferoxamine trial. It brings up an interesting point about trial design and confidentiality: who has a right to terminate industry-academia trials, the manufacturer or the investigator? Oldham, R. (2005). Unlucky Jim. Wall Street Journal. February 18, 2005.       This short but effective news article chronicles a patient who succumbs to cancer after failed attempts to receive novel therapies in kidney cancer. It points out the failures of clinical trial selection criteria to deliver medicine to those in most dire need. Ramsay, D. W., S. (2001). "The Use and Usefulness of Placebo Controls." Science 294(5543): 785.       The "placebo effect" can mar research results and diminish drug effects in clinical trials. With our society becoming increasingly dependent on drugs, we are also becoming conditioned to feel a drug effect when it is not really there. Interesting article. << 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)