#TOPCAT CLINICAL TRIAL TRIAL#

In a high level analysis, most drugs were discontinued in Phase III due to inadequate efficacy (44 percent) or safety issues (24 percent). 2 Inadequate Efficacy and/or Safety Issues In contrast, the current 50 percent negative outcome rate in Phase III trials adds substantially to the cost of drug development and may have important financial consequences for the sponsors. These early phase and proof-of-concept trials are truly РІР‚Сљexperimental,РІР‚Сњ and no one expects every new compound to progress to Phase III.

#TOPCAT CLINICAL TRIAL TRIAL#

In Phase I-II trials, negative trial outcomes as high as 70 percent are to be expected.

Fortunately, support for publishing negative-outcome trials has expanded substantially in the past few years as the stakeholders in the drug development process realize the importance of sharing this information. РІР‚СљPublication biasРІР‚Сњ encompasses both lack of enthusiasm for the time and effort of publishing the details of a negative or failed trial on the part of the sponsor and investigators and lack of interest in devoting page space to negative-outcome trials on the part of journal editors and publishers.

Largely because of a long tradition of publication bias, there are not a lot of data on negative-outcome trials.

On the other hand, a poorly designed and executed trial with weak statistics but a nominally positive outcome qualifies as a РІР‚Сљfailed trialРІР‚Сњ because it represents a waste of time and effort-it will not survive the scrutiny of regulatory or peer review. LetРІР‚в„ўs be clear: a well-designed and well-conducted Phase III drug trial that has very few or no missing data and robust statistics but does not demonstrate positive efficacy and safety for a potential new therapeutic agent is not a РІР‚Сљfailed trial.РІР‚Сњ ItРІР‚в„ўs a good trial with a negative outcome.

Topcat clinical trial