Clinical Trial Planning in Chile

Welcome and thank you for reading BOPAL’s inaugural blog post!

 

This blog post will be the first in a series that discusses the key high-level timelines to account for when planning a clinical trial to include various countries in Latin America.

Because BOPAL is based in Chile, we will start there with today’s post.

 

Chile – Clinical Research insights

 

  • Chile holds a significant place in the conduct of clinical studies in Latin America and it is expected that it’s importance in the region will continue to increase in the near future.
  • As the clinical studies implemented in the country cover all study phases and major therapeutic areas, Chile is a candidate for most studies that are considered for Latin America.
  • Main strengths of Chile are high quality data, investigators and great sustained

 

  • Chile has an outstanding position within the LATAM region:
      • Short regulatory timelines: 28 business days for regulatory review
      • Reliability and performance
      • Major quality referent
  • Of the total number of clinical studies financed by the industry in LATAM, 85% of them are carried out in only 5 countries: Chile, Argentina, Mexico, Colombia and Brazil.
  • Out of these 5 countries with the largest number of clinical studies, Chile is the one with the highest rate of studies per inhabitant in the region (See Table below).

 

Country Number of studies Population (Million) Studies/Million
Chile                            1.340                                  19,1                        70,2
Argentina                            2.715                                  45,3                        59,9
Panamá                                241                                     4,3                        56,0
Costa Rica                                165                                     5,0                        33,0
Perú                                860                                  32,9                        26,1
México                            2.955                                128,9                        22,9
Colombia                            1.083                                  50,8                        21,3
Guatemala                                262                                  16,8                        15,6
Brazil                            3.199                                212,6                        15,0
Dominican Republic                                147                                  10,8                        13,6
Paraguay                                  49                                     7,1                           6,9
Uruguay                                  23                                     3,4                           6,8
El Salvador                                  35                                     6,4                           5,5
Honduras                                  50                                     9,9                           5,1
Cuba                                  46                                  11,3                           4,1
Venezuela                                101                                  28,4                           3,6
Ecuador                                  60                                  17,6                           3,4
Haití                                     9                                  11,4                           0,8
Nicaragua                                     5                                     6,6                           0,8
Bolivia                                     5                                  11,7                           0,4
*Source: clinicaltrials.gov
*Filtered by: Interventional; Funding: Industry
*Date of review: 22Aug2022

 

Chile – Clinical Studies Flowchart of Approval

 

*Source: InvestChile Insights – eBook Series – The Pharmaceutical Industry in Chile; 1st Edition April 2022

 

 

At BOPAL we are experts in all aspects of the Chilean regulatory environment for clinical trials and would be honored to support your organization in conducting research here.

To discuss planning your clinical trial in Chile, please contact at pablo@bopal.cl

 

 

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