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Características de los ensayos clínicos autorizados en el Perú, 1995-2012
| Content Provider | Scilit |
|---|---|
| Author | Minaya, Gabriela Fuentes, Duilio Obregón, Cristian Ayala-Quintanilla, Beatriz Yagui, Martín |
| Copyright Year | 2012 |
| Description | To identify main characteristics of clinical trials (CT) authorized by the National Institute of Health (INS) of Peru from 1995 to August 2012. 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. 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. 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. |
| Related Links | http://www.scielosp.org/scielo.php?script=sci_pdf&pid=S1726-46342012000400003&lng=es&nrm=iso&tlng=es |
| Ending Page | 436 |
| Page Count | 6 |
| Starting Page | 431 |
| ISSN | 17264634 |
| e-ISSN | 17264642 |
| DOI | 10.1590/s1726-46342012000400003 |
| Journal | Revista Peruana de Medicina Experimental Y Salud Publica |
| Issue Number | 4 |
| Volume Number | 29 |
| Language | English |
| Publisher | FapUNIFESP (SciELO) |
| Publisher Date | 2012-12-01 |
| Access Restriction | Open |
| Subject Keyword | Revista Peruana de Medicina Experimental Y Salud Publica Tropical Medicine Biomedical Research Clinical Research |
| Content Type | Text |
| Resource Type | Article |
| Subject | Public Health, Environmental and Occupational Health |
