Program

PO1-13-8

Feasibility of conducting Phase 1 clinical trials in low-middle income countries (LMIC) - The case of Argentina

[Speaker] Ventura A Simonovich:1
[Co-author] Mariana G Fernandez:2, Paula Scibona:1, Cintia V Cruz:1,2, Valeria Beruto:1, Waldo H Belloso:1
1:Sección Farmacología Clínica, Hospital Italiano de Buenos Aires, Argentina, 2:Unidad académica II de Farmacología - Universidad de Buenos Aires, Argentina

Background:
During the last decades we have witnessed the globalization of clinical research. However, this phenomenon has not been observed in early phase studies which have a higher risk-benefit balance. In this article we aimed to identify the challenges and possible benefits of allocating phase 0/1 clinical trials in LMIC using Argentina as a case study.
 
Methods:
We included all drugs phase 1 studies registered in ANMAT (Argentinian Regulatory Authority) database, clinicaltrials.gov and in the WHO International Clinical Trials Registry Platform (ICTRP) approved between 2007 and 2017. We analyzed type of study, therapeutic area, patient population and industry- vs non-industr-sponsored.

We also review the feasibility by assessing the infrastructure and regulatory requirements.
 
Results:
We found 90 drug interventional phase 1 clinical studies. 25 were bioequivalence studies (29%). The majority were sponsored by foreign companies rather than national investigations (64 studies, 71%). Excluding bioequivalence, clinical trials were more frequent in patients (82%), with only 12 involving healthy volunteers. Almost a third of the clinical trials involved pediatrics (19 studies, 29%).

Argentina has health indicators comparable to those of high income countries. There are 7285 accredited Investigational sites, including dedicated Phase 1 Units. 38 of these sites have had experience with Phase 1 Trials in the last 10 years.

In May 2017 ANMAT established a new legislation setting a maximum extension of review period. These approval timelines are comparable to those of European countries. Current regulatory environment maintains high protection standards for participants while providing adequate stimulus and opportunities for this growing field.

Institutional Review Boards have stringent requirements for composition and functioning. Local Investigators must demonstrate both training and experience in the conduction of clinical trials. This changes contributes to the overall high quality standards of the research data generated in the country.

Conclusions:
Research capabilities in Argentina are rising. Experience has been built in the past ten years. The country has a well-developed Health Care System, GCP based sites and timelines are similar to some european regulatory agencies.

The remaining gap in infrastructure and know-how to conduct more complex studies could be addressed by public-private collaborations.

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