The China tuberculosis clinical trials consortium network: a model for international TB clinical trials capacity building
Abstract Background With the second largest tuberculosis (TB) burden globally, China is committed to actively engage in international TB clinical trials to contribute to global TB research. However, lack of research capacity among local sites has been identified as a barrier. Main text The China Tub...
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doaj-b6249398be254af1a1d14427d11163f42020-11-25T02:05:54ZengBMCInfectious Diseases of Poverty2049-99572020-05-01911710.1186/s40249-020-00671-wThe China tuberculosis clinical trials consortium network: a model for international TB clinical trials capacity buildingYu-Hong Liu0Shu Chen1Jing-Tao Gao2Yao Zhang3Kimberly Booher4Xiao-Fen Ding5Wei Shu6Jian Du7Jing Bao8Richard Hafner9Carol D. Hamilton10Liang Li11Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor InstituteFHI ClinicalBeijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor InstituteBrii BiosciencesFHI ClinicalFHI ClinicalBeijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor InstituteBeijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor InstituteU.S. National Institutes of Health (NIH)U.S. National Institutes of Health (NIH)Duke University Medical CenterBeijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor InstituteAbstract Background With the second largest tuberculosis (TB) burden globally, China is committed to actively engage in international TB clinical trials to contribute to global TB research. However, lack of research capacity among local sites has been identified as a barrier. Main text The China Tuberculosis Clinical Trials Consortium (CTCTC) was initiated by Beijing Chest Hospital with investment from the US National Institutes of Health and technical support from Family Health International 360 in 2013, as a nationwide collaborative clinical trial network to strengthen selected clinical site research capacity and attract TB clinical trials. The program aims to: 1) recruit leading hospitals that care for TB patients; 2) conduct on-site assessment to identify capacity gaps and needs for improvement; 3) design and deliver capacity building activities; 4) attract and deliver high quality results for TB clinical trials. A total of 24 sites have joined CTCTC, covering 20 provinces in China. Twenty-two sites have been accredited by the National Medical Products Administration (NMPA) to be qualified to conduct TB clinical trials. The onsite assessment, extensive trainings among the CTCTC sites and young investigators have resulted in better understanding and improvement of the site capacity in conducting TB clinical trials. The establishment and growth of the CTCTC network has benefited from the good leadership, effective international cooperation and local commitment. Issues in human resources, regulatory environment and sustainability have been challenging the network from continuing growth. Clinical researchers have full-time clinical responsibilities in China and it is thus important to build a cadre of other human resources to assist. The regulatory environment is becoming friendlier in China to introduce international clinical trials to the CTCTC network. Conclusions The CTCTC, with mature management structure and sustainable development model, which are distilled five key lessons for other developing countries or investigators of interest. They are the respectively using assessment-based approach to design tailored training package, understanding the availability of clinical researchers, providing solutions to maintain sustainability, understanding local regulatory environments and working with an international organization with local on-site team, respectively. Although, the experiences and capacity of China’s TB hospitals in conducting clinical research vary. Considerable efforts to continue building the capacity are still needed, although the gap is smaller for a few top-tier hospitals.http://link.springer.com/article/10.1186/s40249-020-00671-wClinical trial consortiumTuberculosisCapacity buildingChina |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Yu-Hong Liu Shu Chen Jing-Tao Gao Yao Zhang Kimberly Booher Xiao-Fen Ding Wei Shu Jian Du Jing Bao Richard Hafner Carol D. Hamilton Liang Li |
spellingShingle |
Yu-Hong Liu Shu Chen Jing-Tao Gao Yao Zhang Kimberly Booher Xiao-Fen Ding Wei Shu Jian Du Jing Bao Richard Hafner Carol D. Hamilton Liang Li The China tuberculosis clinical trials consortium network: a model for international TB clinical trials capacity building Infectious Diseases of Poverty Clinical trial consortium Tuberculosis Capacity building China |
author_facet |
Yu-Hong Liu Shu Chen Jing-Tao Gao Yao Zhang Kimberly Booher Xiao-Fen Ding Wei Shu Jian Du Jing Bao Richard Hafner Carol D. Hamilton Liang Li |
author_sort |
Yu-Hong Liu |
title |
The China tuberculosis clinical trials consortium network: a model for international TB clinical trials capacity building |
title_short |
The China tuberculosis clinical trials consortium network: a model for international TB clinical trials capacity building |
title_full |
The China tuberculosis clinical trials consortium network: a model for international TB clinical trials capacity building |
title_fullStr |
The China tuberculosis clinical trials consortium network: a model for international TB clinical trials capacity building |
title_full_unstemmed |
The China tuberculosis clinical trials consortium network: a model for international TB clinical trials capacity building |
title_sort |
china tuberculosis clinical trials consortium network: a model for international tb clinical trials capacity building |
publisher |
BMC |
series |
Infectious Diseases of Poverty |
issn |
2049-9957 |
publishDate |
2020-05-01 |
description |
Abstract Background With the second largest tuberculosis (TB) burden globally, China is committed to actively engage in international TB clinical trials to contribute to global TB research. However, lack of research capacity among local sites has been identified as a barrier. Main text The China Tuberculosis Clinical Trials Consortium (CTCTC) was initiated by Beijing Chest Hospital with investment from the US National Institutes of Health and technical support from Family Health International 360 in 2013, as a nationwide collaborative clinical trial network to strengthen selected clinical site research capacity and attract TB clinical trials. The program aims to: 1) recruit leading hospitals that care for TB patients; 2) conduct on-site assessment to identify capacity gaps and needs for improvement; 3) design and deliver capacity building activities; 4) attract and deliver high quality results for TB clinical trials. A total of 24 sites have joined CTCTC, covering 20 provinces in China. Twenty-two sites have been accredited by the National Medical Products Administration (NMPA) to be qualified to conduct TB clinical trials. The onsite assessment, extensive trainings among the CTCTC sites and young investigators have resulted in better understanding and improvement of the site capacity in conducting TB clinical trials. The establishment and growth of the CTCTC network has benefited from the good leadership, effective international cooperation and local commitment. Issues in human resources, regulatory environment and sustainability have been challenging the network from continuing growth. Clinical researchers have full-time clinical responsibilities in China and it is thus important to build a cadre of other human resources to assist. The regulatory environment is becoming friendlier in China to introduce international clinical trials to the CTCTC network. Conclusions The CTCTC, with mature management structure and sustainable development model, which are distilled five key lessons for other developing countries or investigators of interest. They are the respectively using assessment-based approach to design tailored training package, understanding the availability of clinical researchers, providing solutions to maintain sustainability, understanding local regulatory environments and working with an international organization with local on-site team, respectively. Although, the experiences and capacity of China’s TB hospitals in conducting clinical research vary. Considerable efforts to continue building the capacity are still needed, although the gap is smaller for a few top-tier hospitals. |
topic |
Clinical trial consortium Tuberculosis Capacity building China |
url |
http://link.springer.com/article/10.1186/s40249-020-00671-w |
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