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Clinical trials are research studies that prospectively assign individuals to one or more interventions to evaluate their effects on health outcomes. These interventions include medicines, vaccines, medical devices, procedures, and public health and health systems interventions. In the Americas, clinical trials are essential for generating high-quality evidence, strengthening evidence-based decision-making, and responding to public health priorities and emergencies. PAHO promotes ethical, efficient, and collaborative clinical trials in the Region.

  • Clinical trials enable the identification of safe, effective, and high-quality interventions.
  • They are not limited to medicines or devices; they also include public health and health systems interventions.
  • Large-scale and collaborative trials generate stronger and more relevant evidence for public health.
  • Public registration of clinical trials is key to transparency and scientific integrity.
  • Rigorous ethical review and efficient regulation protect participants and strengthen public trust.
  • Ethical and regulatory harmonization reduces delays without compromising protection.
  • They are essential for evidence-based health policies and programs.
  • Gaps in capacity, coordination, and regulatory frameworks persist in the Region.
  • Regional networks facilitate high-impact multicenter trials.

PAHO supports countries in the Region in strengthening clinical trials through the PAHO’s Clinical Trial Accelerator, a regional initiative aimed at improving efficiency, quality, and impact of clinical research. PAHO promotes regional cooperation, strengthens national capacities, supports ethical and regulatory governance, and facilitates access to information, tools, and good practices through the Clinical Trials Portal of the Americas.

Highlights

PAHO Clinical Trial Accelerator (April 9, 2026)

Virtual seminar series on topics related to clinical trials

  1. Alternative approaches to vaccine efficacy trials (Aug. 25, 2026)
  2. Ethical preparedness for research in emergencies  (June 12, 2026)
  3. Adaptive and platform trials (May 6, 2026)
  4. PAHO Clinical Trial Accelerator (April 9, 2026)
  5. Ethics of human challenge studies (March 2, 2026)
  6. Artificial intelligence and ethics review of research: challenges and opportunities (Dec. 2, 2025)
  7. Rethinking the concept of vulnerability in research (Nov. 7, 2025)
  8. Clinical trials on advanced therapies (Oct. 21, 2025)
  9. Regional template for clinical trial agreement (Aug. 26, 2025)
  10. Ethical inclusion of pregnant participants in clinical trials (Aug. 13, 2025)
  11. Pre-approved protocols for clinical trials: Importance and pending challenges (June 18, 2025)
  12. Template for clinical trial contract and insurance policy: regional proposal (June 4, 2025)
  13. How to promote more and better clinical trials in Latin America and the Caribbean? (May 6, 2025)
  14. New guideline for Good Clinical Practice: E6(R3) (March 18, 2025)
  15. Why and how to promote collaboration in health research? (Feb 27, 2025)
  16. Research contracts and insurance policies for clinical trials: Regional challenges (Dec. 05, 2024)
  17. Research integrity and responsible conduct of research (Nov. 14, 2024)
  18. Clinical trial registration and the International Clinical Trials Registry Platform (ICTRP) (Oct. 9, 2024)
  19. Challenges of adaptive trials (Sep. 25, 2024)
  20. The U.S. single IRB policy: challenges and lessons (Aug. 30, 2024)
  21. Data Monitoring Committees (DMCs) and the role of ethics (Jul. 17, 2024) 
  22. Animal research and the role of committees for the care and use of animals (Jun. 12, 2024) 
     
    Other virtual seminars

    -Tool for the accreditation of research ethics committees (Jan. 31, 2024) 
    -What are the regulatory tasks in the oversight of clinical trials? (Nov. 21, 2023) 

    Virtual regional bilingual workshop: Material Transfer Agreements and Data Transfer Agreements

    -Material and data transfer agreements: basic notions (Oct. 10, 2023) 
    -Material and data transfer agreements in practice (Oct.17, 2023) 
    -Roles, responsibilities, and challenges when using material and data transfer -agreements (Oct. 24, 2023)
    -Regulations of material and data transfer agreements (Oct. 31, 2023)
     

Infographic: Oversight of research

catalizar-web

Website: Catalyzing Ethical Research in Emergencies (Full publication and abstracts in four languages with its inputs).

Publication: Regional template for clinical trial agreement (Oct. 2025). Available also in Spanish and Portuguese.

-Regional template for clinical trial agreement (PAHO, 2025 / Available also in Spanish and Portuguese)

-Questions to guide the ethics analysis of research involving humans (PAHO, 2025 / Available also in Spanish I Portuguese I French)

-Orientación sobre mejores prácticas para los ensayos clínicos (PAHO, 2025 / Available also in Portuguese)

-Guidance for best practices for clinical trials (WHO, 2024)

-The revision of the Declaration of Helsinki viewed from the Americas—Paving the way to better research (JAMA, 2024)

-Advancing collaborative research for health: why does collaboration matter? (BMJ Global Health, 2024)

-Tool for the accreditation of research ethics committees (PAHO, 2023)

-Final report of the regional workshop: Strengthening clinical trials to provide high-quality evidence on health interventions, and to improve research quality and coordination (PAHO, 2023)

-Strengthening national research ethics systems in the Americas to improve its ethics preparedness and response to emergencies (Kaleidoscope of Global Bioethics, Conselho Nacional de Ética para as Ciências da Vida, 2023)

-Catalyzing Ethical Research in Emergencies: Recommendations for research ethics committees (PAHO, 2023)

-Catalyzing Ethical Research in Emergencies: Recommendations for health authorities  (PAHO, 2023)

-Catalyzing ethical research in emergencies. Ethics guidance, lessons learned from the COVID-19 pandemic, and pending agenda. Summary (PAHO, 2022)

-Catalyzing ethical research in emergencies. Ethics guidance, lessons learned from the COVID-19 pandemic, and pending agenda (PAHO, 2022)

-Research ethics systems in Latin America and the Caribbean: a systemic assessment using indicators (The Lancet Global Health, 2022)

-Mapeo de protocolos de investigación, publicaciones y colaboraciones sobre la COVID-19 en América Latina y el Caribe (OPS, 2022). Available only in Spanish.

-Indicators for strengthening national research ethics systems (PAHO, 2021)

-The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges (Pan American Journal of Public Health, 2020)

-Advancing research ethics systems in Latin America and the Caribbean: a path for other LMICs? (The Lancet Global Health, 2019)

-Pregnant women & vaccines against emerging epidemic threats. Ethics guidance for preparedness, research, and response (PREVENT - Johns Hopkins Berman Institute of Bioethics, 2018)

-An ethics call for the inclusion of pregnant women in research (Pan American Journal of Public Health, 2016)

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