TY - JOUR
T1 - Advances in Clinical Research in Ecuador
AU - Ramos, Thelvia I.
AU - Castro, Karina Alexandra
AU - Escalante, Luis Santiago
AU - Santiago Vispo, Nelson
N1 - Publisher Copyright:
© The Author(s) 2017.
PY - 2017/5/1
Y1 - 2017/5/1
N2 - Ecuador is undergoing a process of clinical research development and strengthening. At the turn of the century, Ecuador experienced a favorable transition period of economic stability, which enabled advances in the health system and improvements in population welfare indicators. During this period, Ecuador created an institutional infrastructure to support the implementation and development of research projects. In turn, Ecuador created institutions, including the National Agency for Health Regulation, Control, and Surveillance (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria [ARCSA]), and regulations establishing clinical trial (CT) design, conduct, recording, and reporting parameters, whose compliance ensures the protection of the rights of research subjects and requires compliance with Good Clinical Practice (GCP). Ecuador has favorable conditions for fostering the development of clinical research. The regulation of CTs is a process undergoing consistent changes toward harmonization with international standards and quality assurance.
AB - Ecuador is undergoing a process of clinical research development and strengthening. At the turn of the century, Ecuador experienced a favorable transition period of economic stability, which enabled advances in the health system and improvements in population welfare indicators. During this period, Ecuador created an institutional infrastructure to support the implementation and development of research projects. In turn, Ecuador created institutions, including the National Agency for Health Regulation, Control, and Surveillance (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria [ARCSA]), and regulations establishing clinical trial (CT) design, conduct, recording, and reporting parameters, whose compliance ensures the protection of the rights of research subjects and requires compliance with Good Clinical Practice (GCP). Ecuador has favorable conditions for fostering the development of clinical research. The regulation of CTs is a process undergoing consistent changes toward harmonization with international standards and quality assurance.
KW - clinical research
KW - clinical trials
KW - economic development
KW - Ecuador
KW - pharmaceutical
UR - http://www.scopus.com/inward/record.url?scp=85018439613&partnerID=8YFLogxK
U2 - 10.1177/2168479016680257
DO - 10.1177/2168479016680257
M3 - Article
C2 - 30231695
AN - SCOPUS:85018439613
SN - 2168-4790
VL - 51
SP - 307
EP - 313
JO - Therapeutic Innovation and Regulatory Science
JF - Therapeutic Innovation and Regulatory Science
IS - 3
ER -