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Clinical trials for genetic diseases in Latin America
Author(s) -
Poswar Fabiano de Oliveira,
Silva Larissa Pozzebon,
Zambrano Marina Bauer,
Pedrini Diane Bressan,
Saute Jonas Alex Morales,
Giugliani Roberto
Publication year - 2021
Publication title -
american journal of medical genetics part c: seminars in medical genetics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.419
H-Index - 101
eISSN - 1552-4876
pISSN - 1552-4868
DOI - 10.1002/ajmg.c.31934
Subject(s) - latin americans , legislation , orphan drug , clinical trial , medical genetics , political science , drug development , drug trial , economic growth , medicine , genetics , biology , bioinformatics , drug , law , psychiatry , pathology , gene , economics
Latin American geneticists have been contributing to the scientific development of Human and Medical Genetics fields since the early 1950s. In the last decades, as Medical Genetics is moving toward a new era of innovative therapies for previously untreatable conditions, the participation of Latin America in clinical trials is also increasing. This review discusses the particularities regarding funding, regulatory, and ethical aspects of conducting clinical trials for genetic diseases in Latin America, with an especial focus on Brazil, the largest country with the highest number of studies. Although there are still several barriers to overcome, the recent development of orphan drug legislation and policies for rare diseases in many Latin American countries indicates a growing opportunity for the participation of the region in international efforts for the development of new therapies for genetic diseases.