The patent's assignee for patent application serial number 794901 is Ubc Specialty Clinical Services, Llc.
News editors obtained the following quote from the background information supplied by the inventors: "The failure of clinical trials to detect significant differences in efficacy between treatment groups is a well-recognized and increasingly costly impediment to clinical drug development (Robinson & Rickels, 2000,
"Placebo-controlled trials are increasingly difficult to justify on ethical grounds when an effective treatment is known (Quitkin, 1999, Am. J. Psychiatry 156: 829-836). In order to assure assay sensitivity, and/or in response to regulatory requirements, more trials are incorporating active comparators--drugs which are known to have efficacy in treating a particular disorder. In such trials sensitivity assumes an even more important role for detecting the small differences between two positive outcomes.
"To enhance the statistical power of a given clinical trial, investigators can simply include greater numbers of patients. However, this approach has several major drawbacks. First, it adds substantially to the cost of performing clinical trials, as the cumulative per-subject costs often represent the majority of the total costs of a trial. More importantly, this approach requires that larger numbers of patients be exposed to experimental drugs, or drugs that may not yet have shown clear benefit for their illness. Unfortunately, increasing the number of patients is also associated with an increased placebo response rate (Keck et al. 2000, Biol. Psychiatry 47: 748-755; Keck et al., 2000, Biol. Psychiatry 47: 756-761; Shatzberg & Kraemer, 2000, Biol. Psychiatry 47: 736-744), thereby negating to some extent the benefit of an increased sample size.
"Another mechanism for enhancing the power of a clinical trial involves improving the reliability of outcome measurements (Leon et al., 1995, Arch. Gen. Psychiatry 52: 867-871). When outcome measurements require human evaluation of clinical status, reliability depends on the skills of the human raters performing the evaluation. Improving and/or making the skills of human raters reliable and sensitive present a significant hurdle in designing, conducting, and even analyzing clinical trials.
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