Understanding the role of randomization in clinical research and practice

Abstract

Background: The scientific role randomization plays in clinical research is universally recognized, but poorly understood. In stark contrast, the ethical role randomization plays in the proper care of patients in the presence of uncertainty has been almost completely ignored.

Methods: We review the introduction of randomization in the design of experiments, its first use in Britain, and its essential role in analysis of statistical results. We also review Thomas Chalmers' argument from 1975 that showed the ethical role randomization can play in the care of patients. We discuss how Chalmers' vision can be generalized to all contexts of clinical uncertainty.

Discussion: Randomization is not only essential to the validity of statistical tests, it is also the best way to learn from experience. Although Chalmers' admonition to 'Randomize the first patient' pertained to the use of innovations, the notion that randomized allocation can be done in the best interest of patients is generalizable to all medical or surgical interventions that have yet to be proven beneficial, opening the perspective that care research can be integrated into practice in the best medical interest of patients.

Conclusion: Randomized allocation plays crucial scientific and ethical roles both in research and practice. It is the most efficient way to learn from experience. Prior to this gain in knowledge, it is the way to optimize care in the presence of uncertainty.

Keywords: Benefits of randomization; Ethical functions of trials; Randomized trials.