Relative risk reduction: Misinformative measure in clinical trials and COVID-19 vaccine efficacy

Abstract

Treatment and vaccine efficacy in clinical trials are often reported in the media and medical journals as the relative risk reduction. The present article explains why the relative risk reduction is a misinformative measure that promotes disinformation when reporting efficacy in clinical research studies such as randomized controlled trials for COVID-19 vaccines. The relative risk reduction is based on the relative risk, a proportional measure or ratio used in epidemiologic studies to estimate the probability of a disease associated with an exposure. The present article demonstrates how the relative risk reduction and relative risk obscure the magnitude of disease risk reduction in clinical research. The absolute risk reduction is shown to be a more precise and reliable measure of treatment and vaccine efficacy in clinical research studies. The absolute risk reduction reciprocal also measures the number needed to treat or vaccinate, and is a more accurate measure than the relative risk reduction for comparing risk reductions of clinical studies. Additionally, the present article reviews consequences of COVID-19 vaccine efficacy misinformation disseminated through media reports. The article concludes that relative risk reduction should not be used to measure treatment and vaccine efficacy in clinical trials.

What is new?: •Unreliability of relative measures in clinical trials is graphically illustrated, demonstrating constant relative measures as absolute measures change.•Misuse of relative measures in clinical research is historically linked to misinterpretation of Jerome Cornfield's advice on measuring causative and associative effects.•Consequences of disinformation and misinformation related to COVID-19 vaccine efficacy and modern clinical medicine are described.•The proper use of absolute measures in meta-analyses is explained.

Keywords: ARR, Absolute risk reduction; Absolute risk reduction; CDC, Centers for Disease Control and Prevention; CER, Control event rate; COVID-19 vaccines; COVID-19, Coronavirus Disease-2019; Control event rate; EER, Experimental event rate; Experimental event rate; FDA, Food and Drug Administration; NNT, Number needed to treat; NNV, Number needed to vaccinate; Number needed to treat; Number needed to vaccinate; RR, Relative risk; RRR, Relative risk reduction; Relative risk; Relative risk reduction; SARS-CoV-2, Severe Acute Respiratory Syndrome-Coronavirus-2; VE, Vaccine efficacy; Vaccine efficacy; mRNA, Messenger ribonucleic acid; microRNA, Micro ribonucleic acid.