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Title Are large clinical trials in rapidly lethal diseases usually unethical?
Author Horrrobin, DF
Year 2003
Journal Lancet
Volume 361
Pages 695-697
Link for Open Access
Link for DOI
Web_Access_Paper [proprietary]
Contributed_by Peter Bacchetti
Commentary This described the author's new insights after becoming a cancer patient and seeing medical research from a different perspective. It provided poignant personal thoughts and some compelling reasoning and anecdotes, but it was experience-based rather than evidence-based. He gave four reasons why large trials are often unethical. First, they are large because the expected effect is very small. Patients have little interest in incremental improvements and would rather try more speculative treatments, but they are not adequately informed of the small expected effects. Second, large trials take too long and cost too much. They provide financial benefits to participating institutions, but most participating patients will be dead before the results of the trial are known, and patients are not adequately informed of these facts. Third, the high costs prevent the evaluation of promising treatments that lack profit potential because they cannot be patented. Fourth, larger trials reduce the number of treatments that can be evaluated, because patients and resources are limited; he even claimed that companies have conducted over-large trials to preclude conduct of other trials and thwart competition. He concluded that it would be better and more aligned with patients' desires if "we largely abandon large-scale trials looking for small effects and instead do large numbers of small trials, often in single centres, looking for large effects." He did not consider a few important possibilities: 1) small overall effects could result from large benefits to a few patients, and for a particular patient this could roughly equate to a remote possibility of a speculative treatment's having a large overall effect; 2) incremental improvements can build over decades into substantial effects; and 3) higher costs of multi-center trials could be partly or wholly the result of higher quality-assurance costs, which single-center studies might avoid only by allowing lower quality. Empirical or historical investigation could shed more light on these areas, along with whether multi-center studies really do cost more per patient. Other subjective impressions reported in the paper could also be confirmed or corrected by empirical research into patient preferences for large incremental trials versus speculative high-risk-high-payoff ones, the importance of altruistic motivations versus potential personal benefit, and patients' understanding of information in consent documents about studies' scientific goals and expected effect sizes. His overall argument relied heavily on the existence of many as-yet unevaluated treatments with at least some small possibility of having large effects, which could be disputed.
Reference_Subject Biostat_Ethics
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