Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance - PubMed (original) (raw)
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Development of new TB regimens: Harmonizing trial design, product registration requirements, and public health guidance
Christian Lienhardt et al. PLoS Med. 2019.
Abstract
Christian Lienhardt and colleagues discuss the importance of communication and coordination between regulators, researchers, and policy makers to ensure tuberculosis trials provide high-quality evidence for policy decisions.
Conflict of interest statement
I have read the journal's policy and the authors of this manuscript have the following competing interests: At the CDC, AAV serves as part of a research group doing clinical trials in tuberculosis. His group (TBTC) works often in collaboration with pharmaceutical companies, who may provide modest support, such as drug supplies or funding for PK sub-studies. One company, Sanofi, has provided 6 unrestricted grants to the CDC Foundation over the years 2007–2015 totaling ~$2.8 million to facilitate or support TBTC work related to rifapentine. These funds have supported several PK sub-studies, supported 3 contract research staff, have funded travel to TBTC scientific meetings for invited speakers (all in coach class), and have supported expenses related to fulfillment of company requests for data and data formats as part of their efforts to use TBTC data to support regulatory filings. None of these funds have otherwise benefited members of his research group.