Current oncology reports
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Current oncology reports · Sep 2001
ReviewConflict of interest in industry-sponsored economic evaluations: real or imagined?
As industry sponsorship of pharmacoeconomic studies has increased, concerns have been raised about potential biases, owing to the conflicts of interest that this sponsorship creates. A review of the literature indicates that there are some causes for concern, given the fact that most pharmacoeconomic studies report positive findings for the sponsor's drug. However, a more detailed analysis suggests that, although the methodologic quality of some published studies may be poor, the main reason for positive results is that companies only sponsor economic studies where a positive outcome is likely. Therefore, it is concluded that the best way of dealing with perceptions of sponsorship bias is not increased rhetoric, but rather increased public funding for economic evaluation of medicines, thereby creating a true mixed economy for research funding in this field.
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Current oncology reports · Sep 2001
Acknowledgment of uncertainty: a fundamental means to ensure scientific and ethical validity in clinical research.
Recognition of the importance of uncertainty in the design of randomized, controlled trials (RCT) has reached the status of a principle. The "uncertainty principle," or less ambiguously, equipoise, holds that a patient should be enrolled in an RCT only if there is substantial uncertainty about which of the trial treatments would benefit the patient most. In fact, the "uncertainty principle" addresses the most important issue of a clinical trial--the choice of an adequate comparative control. ⋯ However, we found no evidence of such a policy in the randomized, controlled trials we examined. We also show that there is a predictable relationship between the uncertainty principle, that is, the moral principle upon which trials are based, and the ultimate outcomes of clinical trials. We postulate that about 50% of innovations are successful, leading to the conclusion that preserving the ethics of clinical research may be the best investment strategy available.