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

A5350: Effects of Visbiome Extra Strength on Gut Microbiome...

Many factors contribute to the development of aging-related conditions, including gastrointestinal (GI) diseases, such as...

Read More

IMPAACT 2034 - Phase I Study of the Pharmacokinetics,...

This is a Phase I, multi-site, open-label, non-comparative study of the PK, safety, tolerability, and acceptability of a...

Read More

NWCS 445: Novel Biomarkers to Shorten TB Treatment

Objectives: Primary: To develop a highly predictive algorithm that identifies TB patients who will be cured by treatment...

Read More

A5322: Long-Term Follow-up of Older HIV-infected Adults in...

The A5322 protocol is a long-term observational study, with a planned series of analyses of data to be collected from an...

Read More

P1077BF: Breastfeeding Version of the PROMISE Study...

1077BF is a randomized strategy trial, which is part of the PROMISE studies (1077BF, 1077FF, P1084s, and 1077HS). The Promoting...

Read More