title: Building clinical trial capacity to develop a new treatment for multidrug-resistant tuberculosis.
abstract: OBJECTIVE
  New drugs for infectious diseases often need to be evaluated in low-resource settings. While people working in such settings often provide high-quality care and perform operational research activities, they generally have less experience in conducting clinical trials designed for drug approval by stringent regulatory authorities.
  
  
  METHODS
  We carried out a capacity-building programme during a multi-centre randomized controlled trial of delamanid, a new drug for the treatment of multidrug-resistant tuberculosis. The programme included: (i) site identification and needs assessment; (ii) achieving International Conference on Harmonization - Good Clinical Practice (ICH-GCP) standards; (iii) establishing trial management; and (iv) increasing knowledge of global and local regulatory issues.
  
  
  METHODS
  Trials were conducted at 17 sites in nine countries (China, Egypt, Estonia, Japan, Latvia, Peru, the Philippines, the Republic of Korea and the United States of America). Eight of the 10 sites in low-resource settings had no experience in conducting the requisite clinical trials.
  
  
  RESULTS
  Extensive capacity-building was done in all 10 sites. The programme resulted in improved local capacity in key areas such as trial design, data safety and monitoring, trial conduct and laboratory services.
  
  
  CONCLUSIONS
  Clinical trials designed to generate data for regulatory approval require additional efforts beyond traditional research-capacity strengthening. Such capacity-building approaches provide an opportunity for product development partnerships to improve health systems beyond the direct conduct of the specific trial.
authors.affiliation: Tropical Disease Foundation, Makati City, Philippines .
authors.forename: Thelma
authors.initials: T
authors.lastname: Tupasi
authors.affiliation: Otsuka Pharmaceutical Development and Commercialization, Inc., 2440 Research Boulevard, Rockville, Maryland 20850, United States of America .
authors.forename: Rajesh
authors.initials: R
authors.lastname: Gupta
authors.affiliation: Tartu University Lung Hospital, Tartu, Estonia .
authors.forename: Manfred
authors.initials: M
authors.lastname: Danilovits
authors.affiliation: State Agency of Tuberculosis and Lung Diseases, Riga, Latvia .
authors.forename: Andra
authors.initials: A
authors.lastname: Cirule
authors.affiliation: Hospital Nacional Sergio E Bernales, Lima, Peru .
authors.forename: Epifanio
authors.initials: E
authors.lastname: Sanchez-Garavito
authors.affiliation: Shanghai Pulmonary Hospital, Shanghai, China .
authors.forename: Heping
authors.initials: H
authors.lastname: Xiao
authors.affiliation: Unidad de Investigacion, Hospital Nacional Daniel A Carrión, Lima, Peru .
authors.forename: Jose L
authors.initials: JL
authors.lastname: Cabrera-Rivero
authors.affiliation: Hospital Nacional Hipólito Unanue, Lima, Peru .
authors.forename: Dante E
authors.initials: DE
authors.lastname: Vargas-Vasquez
authors.affiliation: Beijing Chest Hospital, Beijing, China .
authors.forename: Mengqiu
authors.initials: M
authors.lastname: Gao
authors.affiliation: Sadr Abassia Hospital, Cairo, Egypt .
authors.forename: Mohamed
authors.initials: M
authors.lastname: Awad
authors.affiliation: Otsuka Pharmaceutical Development and Commercialization, Inc., 2440 Research Boulevard, Rockville, Maryland 20850, United States of America .
authors.forename: Leesa M
authors.initials: LM
authors.lastname: Gentry
authors.affiliation: Otsuka Pharmaceutical Development and Commercialization, Inc., 2440 Research Boulevard, Rockville, Maryland 20850, United States of America .
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Geiter
authors.affiliation: Otsuka Pharmaceutical Development and Commercialization, Inc., 2440 Research Boulevard, Rockville, Maryland 20850, United States of America .
authors.forename: Charles D
authors.initials: CD
authors.lastname: Wells
mesh_terms: D000995:Antitubercular Agents / Q000627:therapeutic use*; D057191:Capacity Building / Q000458:organization & administration* / Q000592:standards; D002985:Clinical Protocols; D004282:Documentation; D017277:Drug Approval; D006801:Humans; D007391:International Cooperation; D009593:Nitroimidazoles / Q000627:therapeutic use*; D010080:Oxazoles / Q000627:therapeutic use*; D012107:Research Design; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents; D009593:Nitroimidazoles; C516022:OPC-67683; D010080:Oxazoles