Chapter 11
Statistical Fragility and Robustness in Pharmaceutical Trials
- By Thomas F. Heston - 18 Oct 2026
- Emerging Trends in Pharmaceutical Sciences and Clinical Studies, Volume: 1, Pages: 64 - 72
Abstract/Preface
A statistically significant trial is supposed to mean something durable: the finding would stand if the experiment were run again. Over the past two decades, that assumption has failed repeatedly under direct examination [1,2]. Empirical replication programs confirmed the concern: when 100 published psychology experiments were repeated with high-powered designs, 97% of the original studies had reported statistically significant results, but only 36% of the replications did [3]. The pharmaceutical industry encountered the same problem from the inside, as systematic in-house attempts to reproduce published preclinical findings succeeded in only a minority of cases [4,5]. In clinical medicine and therapeutics, the stakes of evidentiary instability and medical reversal are concrete: regulatory authorizations, prescribing patterns, and clinical practice guidelines directly depend on the reliability and replication of published trials [6].