Association between health-related quality-of-life results, outcomes of efficacy and drug approvals: a meta-research study of randomized phase III trials in oncology.

ABSTRACT:

Background

Despite the interest from the scientific community and regulatory agencies, limited data are available on the association between health-related quality-of-life (QoL) results, outcome of efficacy and drug approvals.

Materials and methods

We updated the previously published meta-research study of phase III clinical trials in patients with solid tumours treated with systemic treatments, published from 2012 to 2021 in 11 selected journals. For the present analysis, we focused on studies conducted in the advanced setting. The primary outcome was the association of global QoL results with study primary endpoints (EP1), overall survival (OS) and progression-free survival (PFS), while a secondary outcome was the frequency of positive global QoL results among treatments a

SUBMITTER: Paratore C 

PROVIDER: S-EPMC11410715 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature