Peripheral Neuropathies: Controlled Clinical Trials

Abstract

The term “controlled clinical trials” at a minimum implies testing whether a prospectively administered intervention (a drug, diet, activity or other therapy) prevents, stabilizes or ameliorates clinical polyneuropathy to a clinically beneficial degree when compared with a sham intervention, similar in all respects to the intervention with the exception that the intervention is not included. It is also understood that neither the investigators or patients can identify the intervention from the sham intervention except perhaps by the response. The term “controlled clinical trial” also implies rigorous pre-planning, written design, choice of carefully selected outcomes, estimation of statistical power, written permission agreed to, and supervised by, an institutional review board, periodic evaluation for safety, meticulous record keeping, quality assurance and detailed statistical analysis. Often controlled clinical trials are multicenter studies and funded by a pharmaceutical house, disease advocacy agency or governmental research agency. Typically, the study is registered, modified and monitored by an agency such as the Federal Drug Administration (FDA; in the USA).