Randomized controlled trials, the “gold standard” of evidence-based medicine, derive their strength from strict adherence to methods such as randomization and blinding, which minimize bias and external influences on study data. Even with rigorous methodology, the risk of random error caused by intrinsic data variations remains, but it can be mitigated by increasing sample size.1 In the midst of a nascent pandemic, adequate sample size and other commonly accepted standards of medical research have been set aside for various reasons, including that of single-center attempts at studies that require more subjects than they can recruit on their own. In this article we explore the implications of clinical studies that proceed with small sample sizes during disease outbreaks.
- Clinical studies
- coronavirus disease 2019
- minimal clinically relevant difference
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Critical Care and Intensive Care Medicine
- Cardiology and Cardiovascular Medicine