Applying a risk-benefit analysis to outcomes in tuberculosis clinical trials

Citation: Miyahara S, Ramchandani R, Montepiedra G, Kim S, Gupta A, Swindells S, Chaisson R. Applying risk benefit analysis to outcomes from TB clinical trials. Clin Infect Dis. 2020 Feb 3;70(4):698-703. doi: 10.1093/cid/ciz784. PMID: 31414121.

Access full article:

https://www.ncbi.nlm.nih.gov/pubmed/31414121

Summary
Although it is common to analyze efficacy and safety separately in clinical trials, this could yield a misleading study conclusion if an increase in efficacy is accompanied by a decrease in safety. A risk-benefit analysis is a systematic approach to examine safety and efficacy jointly. Both the "rank-based" and "partial-credit" methods described in this paper allow researchers to create a single, composite outcome incorporating efficacy, safety, and other factors. The first approach compares the distribution of rankings between arms. In the second approach, a score can be assigned to each outcome category, considering its severity and comparing the mean or median scores of arms. The methods were applied to the A5279/Brief Rifapentine-Isoniazid Efficacy for TB Prevention study, and design considerations for future clinical trials are discussed, including the challenge of arriving at a consensus on rankings/scorings. If well designed, a risk-benefit analysis may allow for a superiority comparison and, therefore, avoid setting a noninferiority margin.

Categories

CRS
Topics

Clinical Trials

A5324: A Randomized, Double-Blinded, Placebo-Controlled...

ACTG A5324 is a phase IV randomized, double-blinded, placebo-controlled study to assess the efficacy of adding Maraviroc (MVC)...

Read More

A5314: Effect of LDMTX on Inflammation in HIV-infected...

A5314 is a phase II randomized, double-blind, placebo-controlled 36-week trial that will examine the safety and efficacy of...

Read More

A5300/P2003: PHOENIx Feasibility Study

Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Read More

A5279, Phase III Clinical Trial of Ultra-Short-Course...

This study will enroll HIV-infected people who do not have evidence of active TB but who are at high risk of developing active...

Read More

A5329: Interferon –Free Therapy for Chronic Hepatitis C...

A5329 is a study for people who are infected with both HIV and the Hepatitis C virus (HCV) and have never taken Hepatitis C...

Read More