Study Power in Clinical Trials: A Strategic Choice Beyond Constraints

In the field of drug development, the goal is straightforward: to advance drugs that are safe and efficacious (‘good’ drugs) and halt the development of those that are not (‘bad’ drugs). However, given the inherent uncertainties in measuring safety and efficacy in clinical trials, there are two critical risks to manage. The first is the possibility of advancing a ‘bad’ drug due to a false positive result, known as a Type I error. The second is the risk of discontinuing a ‘good’ drug because of a false negative result, known as a Type II error. Power is defined as the probability of correctly identifying a ‘good’ drug, and is calculated as one minus the Type II error rate. For instance, if there’s a 10% chance that a ‘good’ drug is incorrectly deemed ineffective, the power is 90% (1–0.1). Regulatory bodies like the FDA or EMA have stringent rules to limit Type I errors, while guidelines for Type II errors (power) are more flexible, leaving much of the risk management to R&D companies. Considering the billion-dollar investments involved in drug development, companies aim to be reasonably certain of a drug’s ineffectiveness before deciding to cease its development. <a href="https://medium.com/@nikolas.weissmueller/understanding-study-power-in-clinical-trials-a-choice-not-a-constraint-ca2b7822f9a7">Read More</a>