title: Randomized Trials in Developing Countries: Different Priorities and Study Design?
abstract: BACKGROUND
  Clinical trials are increasingly conducted in the field of neurology in developing countries. To our knowledge, no review has been performed to date about the temporal evolution, geographical distribution, pathological fields, and types of trials conducted. Besides, the validity of those clinical trials needs to be evaluated.
  
  
  CONCLUSIONS
  Our main aim was to describe, using a systematic literature review, the clinical trials performed in the field of neurology in developing countries. The specific objectives were (1) to describe the pathologic fields, (2) to evaluate the methodology, and (3) to assess the validity of neurological clinical trials performed in developing countries. A systematic review of the literature was conducted accessing PubMed, Pascal, ScienceDirect, African Journal Online, and the Virtual Library of African Neurology. The 145 studies included allowed us to identify (1) an exponential evolution of the number of clinical trials, (2) the strong contributions from Asia, followed by Africa and Latin America, (3) a fairly good coverage of pathologic fields including noncommunicable diseases, (4) an increasing diversity of intervention type, (5) the lack of early-phase trials (phases I and IIa), and (5) the need of improvement for some critical methodological issues.
  
  
  CONCLUSIONS
  There is a need (1) to develop structures dedicated to the early investigation of interventions in humans, and (2) for sustaining the development of structures specialized in the methodology of clinical research and of dedicated courses for researchers in tropical areas about good practice in clinical trials. This would help in improving methodological quality, appropriateness of data management, and statistical analysis.
authors.forename: Benoît
authors.initials: B
authors.lastname: Marin
authors.forename: Gino Cédric
authors.initials: GC
authors.lastname: Agbota
authors.forename: Pierre-Marie
authors.initials: PM
authors.lastname: Preux
authors.forename: Farid
authors.initials: F
authors.lastname: Boumédiene
mesh_terms: D016206:Databases, Bibliographic / Q000706:statistics & numerical data; D003906:Developing Countries / Q000706:statistics & numerical data; D006801:Humans; D009422:Nervous System Diseases / Q000453:epidemiology* / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000145:classification / Q000379:methods / Q000706:statistics & numerical data; D012107:Research Design