title: [Characteristics of clinical trials authorized in Peru: 1995-2012].
abstract: OBJECTIVE
  To identify main characteristics of clinical trials (CT) authorized by the National Institute of Health (INS) of Peru from 1995 to August 2012.
  
  
  METHODS
  Cross-sectional study, which reviewed all records of CT submitted for review and possible approval by INS, whose data are part of the Peruvian Registry of Clinical Trials. We performed a descriptive analysis of the states of the CT approval and other characteristics.
  
  
  RESULTS
  1475 clinical trials were assessed, of which 1255 (85.1%) were authorized. From 1 clinical trial officially registered in 1995, its quantity increased to 176 trials submitted in 2008, and then, declined to 128 in 2011. Among the approved CT, 64.1% was in Phase III. Oncology (22.4%), infectious diseases (15.5%) and endocrinology (12.7%) were the most studied specialties and a only 1.2% were for neglected tropical diseases. The oral hypoglycemic drugs, systemic antiviral and antineoplastic agents were the most studied investigational products. The transnational pharmaceutical industry was the main sponsor (87.1%) and executors (62.3%) of clinical trials were mostly in Lima.
  
  
  CONCLUSIONS
  Clinical trials in Peru mainly focus on noncommunicable diseases and phase III studies. The pharmaceutical industry is the main sponsor. A very small number of authorized clinical trials in Peru were for neglected tropical diseases that shows little attention to the health problems in vulnerable populations.
authors: Dirección General de Investigación y Transferencia Tecnológica, Instituto Nacional de Salud, Lima, Perú.
authors: Gabriela
authors: G
authors: Minaya
authors: Duilio
authors: D
authors: Fuentes
authors: Cristian
authors: C
authors: Obregón
authors: Beatriz
authors: B
authors: Ayala-Quintanilla
authors: Martín
authors: M
authors: Yagui
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003430:Cross-Sectional Studies; D006801:Humans; D010568:Peru; D013997:Time Factors