Barriers and facilitators to early access of bedaquiline and delamanid for MDR-TB: a mixed-methods study.

ABSTRACT:

Setting

Phase II trials for bedaquiline (BDQ) and delamanid (DLM) were completed by 2011 and the drugs were approved by stringent regulatory authorities for the treatment of multidrug-resistant tuberculosis (MDR-TB) between 2012 and 2014. Manufacturers established 'early access' mechanisms to provide drugs before local registration.

Objective

To inform improvements in early access, we explored experiences of providers and advocates in accessing BDQ and DLM before the end of 2015 using a mixed-methods design.

Design

We examined barriers and facilitators to early access through an electronic survey. Barriers and facilitators were classified as occurring at the manufacturer- or country-level. We identified themes using inductive content analysis and illustrated themes th

SUBMITTER: Rodriguez CA 

PROVIDER: S-EPMC6436488 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature