(195) Ten-year landscape analysis of clinical research in Latin America: Only 6% of clinical trials make their results public

Publication Number: 856

Background: Globalization and regulatory flexibilities have contributed to the increase of clinical research in lower-and-middle income countries. To date, there is no updated information about clinical trials conducted in Latin American and Latin Caribbean countries.

Objectives: To describe the state-of-the-art of clinical research of medicinal products in Latin American and Caribbean (LAC) region, including transparency outcomes, for the period 2011- 2021.

Methods: Clinical trials conducted in 19 LAC countries, including Cuba and Dominican Republic, were identified in two data sources: ClinicalTrial.gov by US-NLM/NIH and International Clinical Trials Registry Platform by WHO. Clinical trials on chemical synthesis drugs, biologics, advanced therapy, phytotherapeutics, vitamins and minerals performed from 01 January 2011 to 31 December 2021 were selected. Information retrieved from every registry included: population characteristics, therapeutics areas, interventions, the phase of the clinical trial, sponsors, countries, and transparency. Transparency was measured according to the criteria proposed by Cochrane Collaboration, Transparency International and TranspariMED, i.e. registry of the clinical trial before recruitment and publishing a public summary report . Information was analyzed by descriptive statistics. Countries participation in clinical trials was presented as a rate of clinical trials conducted in a given jurisdiction per 1 million inhabitants-year

Results: A total of 35,620 clinical trials were identified. After removal of duplicates (n=19632) and verification of selection criteria, 8,516 records were included in the final analysis. Seventy percent (n=5,898) were international multi-centric studies, and 68.8% industry sponsored. Cancer (22.0%, n=1,869), infectious (12.5%, n=1,068), and endocrine/metabolic diseases (9.6%, n = 815) accounted for close to half of the main research areas. Half of the records were phase III clinical trials (52.2%, n=4,450). Chile (10.14), Argentina (8.13) and Panama (7.61) were the countries with the highest participation per 1 million inhabitants/year. Regarding transparency outcomes, 80% of the clinical trials included were registered before the recruitment; however, only 6% of the 1,296 trials registered as complete have uploaded a summary report of results.

Conclusions: Clinical trials in the LAC region are phase III trials, industry sponsored and conducted in few countries. Research areas do not contribute to overcoming barriers and research needs. Although there is advance in the registration of clinical trials, the publication of main results is scarce. This situation hampers transparency of clinical research and jeopardizes the evidence-based clinical and policy decision-making.