Global Alliance for TB Drug Development, New York, NY 10005, USA.
Lancet. 2010 Jun 12;375(9731):2100-9. doi: 10.1016/S0140-6736(10)60359-9. Epub 2010 May 18.
Drugs for tuberculosis are inadequate to address the many inherent and emerging challenges of treatment. In the past decade, ten compounds have progressed into the clinical development pipeline, including six new compounds specifically developed for tuberculosis. Despite this progress, the global drug pipeline for tuberculosis is still insufficient to address the unmet needs of treatment. Additional and sustainable efforts, and funding are needed to further improve the pipeline. The key challenges in the development of new treatments are the needs for novel drug combinations, new trial designs, studies in paediatric populations, increased clinical trial capacity, clear regulatory guidelines, and biomarkers for prediction of long-term outcome. Despite substantial progress in efforts to control tuberculosis, the global burden of this disease remains high. To eliminate tuberculosis as a public health concern by 2050, all responsible parties need to work together to strengthen the global antituberculosis drug pipeline and support the development of new antituberculosis drug regimens.
治疗结核病的药物不足以应对许多固有的和新出现的挑战。在过去的十年中,有十种化合物进入了临床开发管道,其中包括六种专门为结核病开发的新化合物。尽管取得了这一进展,但全球结核病药物管道仍然不足以满足治疗的未满足需求。需要额外的和可持续的努力和资金来进一步改善管道。新疗法开发的关键挑战是需要新型药物组合、新的试验设计、儿科人群研究、增加临床试验能力、明确的监管指南以及预测长期结果的生物标志物。尽管在控制结核病方面取得了重大进展,但这种疾病在全球的负担仍然很高。为了到 2050 年消除结核病对公共卫生的关注,所有相关方都需要共同努力,加强全球抗结核药物管道,并支持新的抗结核药物方案的开发。