Drugs may inappropriately fail or succeed during development as a result of type I and II chance errors or from flawed methods. Unearned successes can result when designs, practices, methods, or analyses are mistaken, biased, or fraudulent. Needless failures will be almost inevitable if a study tests drug doses that are not adequate to affect the biochemical target. Methodological errors can result in unneeded studies during follow-up of falsely positive CT outcomes or flawed tests of truly effective drugs. Unearned successes and failures will compromise the clinical evidence base, undermine investigators’ confidence in preclinical models, and stifle innovation. The community’s attention can be misdirected and innovation stifled as academia and industry turns toward more promising lines of investigation. Left with a compromised evidence base, medical practitioners and patients seek guidance from next-best sources (1)—published CT reports of variable quality, expert opinions, commercial promotions, and personal experiences.
