COVID-19 Impact on Clinical Trials LATAM: New 2024 Standards & Procedures

Key Takeaways

• Permanent procedural shift: COVID-19 accelerated adoption of remote monitoring and site prequalification in LATAM clinical trials, with ANVISA RDC 945/2024 embedding these as 2024 standards.
• Electronic consent formalized: CONEP Circular 23/2022 normalized electronic consent and remote research activities, protecting participant rights while enabling digital workflows.
• Oncology trial opportunity: Despite carrying over 8% of the global cancer burden, Latin America contributes less than 2% of global oncology trial activity, creating substantial growth potential.
• Competitive positioning: High patient adherence, urban concentration, and cost-efficiency position LATAM sites to attract complex trials previously favoring North America or Europe.

How Did COVID-19 Disrupt LATAM Clinical Trials?

The pandemic created unprecedented disruptions to clinical trial operations globally, and LATAM was no exception. Site closures, travel restrictions, and patient access challenges forced sponsors and clinical research organizations (CROs) to innovate rapidly. According to research in the Pan American Journal of Public Health, the region saw a trend toward small repetitive studies that drained limited resources without producing meaningful conclusions.

Initial pandemic responses in LATAM were reactive. Many sites lacked infrastructure for remote monitoring, digital data capture, and virtual patient visits. The crisis exposed critical gaps: inconsistent site quality standards, limited technological infrastructure, and fragmented regulatory guidance across countries. Rather than reverting to pre-pandemic practices, the industry recognized these innovations addressed fundamental inefficiencies. By 2024, remote monitoring, electronic consent, and enhanced readiness infrastructure became core procedural standards.

What New Procedures Became Standard in 2024?

Remote Monitoring and Distributed Oversight

Remote monitoring has become standard practice in LATAM clinical trials. This shift encompasses virtual patient assessments, remote source data verification, centralized monitoring analytics, and digital patient-reported outcomes collection. Sponsors now deploy hybrid monitoring models that combine periodic site visits with continuous remote surveillance.

The adoption addresses several pre-pandemic challenges. It reduces site burden. It accelerates patient enrollment by eliminating geographic barriers. It enables real-time data quality checks. Remote procedures allow sponsors to deploy monitoring resources efficiently across dispersed LATAM sites, many located in regions with limited infrastructure or challenging travel conditions.

Electronic Consent and Remote Participation

CONEP Circular 23/2022 normalized electronic consent for research participants and biobank donors in Brazil. The circular defines electronic signatures as the final step demonstrating participant agreement to join research. It formalizes remote activities as those conducted without researchers and participants sharing the same location simultaneously.

These measures preserve participant protection, safety, and rights while incorporating technological advances. Researchers must ensure electronic consent processes comply with National Health Council resolutions. The guidance enables broader participant access while maintaining ethical standards.

Site Prequalification Programs

Site prequalification programs enhance trial site readiness before patient enrollment begins. These programs establish standardized criteria for site selection. They assess investigator qualifications, facility infrastructure, regulatory compliance history, patient population characteristics, and technological capabilities.

Prequalification reduces protocol deviations. It improves data quality. It accelerates site initiation timelines by identifying and addressing deficiencies before enrollment commences. ANVISA and regulatory bodies have endorsed prequalification frameworks as best practice, creating harmonized expectations for site readiness across LATAM countries.

What Does ANVISA RDC 945/2024 Establish?

ANVISA RDC 945/2024, published November 29, 2024, defines comprehensive guidelines and procedures for conducting clinical trials with medicinal products in Brazil. The resolution establishes requirements for the Clinical Medicinal Product Development Dossier (DDCM). It applies to all clinical development seeking marketing authorization in Brazil.

The scope covers synthetic and semi-synthetic products, herbal medicines, biological products including biosimilars, radiopharmaceuticals, and medicinal gases. ANVISA may issue specific standards for new clinical trial designs or establish modified procedures during public health emergencies. This flexibility ensures regulatory frameworks can adapt to emerging challenges while maintaining safety standards.

How Have Oncology Trials Been Affected?

Oncology trials in LATAM were early adopters of remote monitoring and site prequalification. The complexity of cancer patient populations, frequent clinic visits for dose adjustments, and geographic dispersion of specialized treatment centers drove adoption. Remote capabilities enable virtual patient assessments, centralized imaging review, and real-time adverse event monitoring without requiring long-distance travel.

Research published in JCO Global Oncology highlights a stark disparity: Latin America carries over 8% of the global cancer burden yet contributes less than 2% of global oncology trial activity and scientific output. This gap represents both a challenge and an opportunity. Remote procedures reduce patient burden, particularly for individuals in rural areas, expanding the accessible patient population for oncology trials.

What Competitive Advantages Does LATAM Now Offer?

The procedural improvements create measurable competitive advantages for LATAM clinical research sites. Sites that invested in remote infrastructure and achieved prequalification status now attract larger, more complex trials that previously favored North American or European locations.

Factor	LATAM Advantage	Impact on Trials
Patient adherence	High retention rates	Reduced dropout, cleaner data
Urban concentration	Major cities host specialized centers	Efficient site selection
Cost efficiency	Lower operational costs	Reduced trial expenditure
Growing networks	Cooperative research groups expanding	Multi-site coordination

Accelerated trial timelines translate to faster regulatory submissions and market entry. Estimates suggest streamlined site initiation and improved enrollment can reduce trial duration by 15-25%. For LATAM as a clinical research destination, these improvements enhance competitiveness against other emerging markets.

What Barriers to Harmonization Remain?

Despite progress in Brazil, challenges remain in harmonizing standards across LATAM countries. Regulatory frameworks, data privacy laws, and technological infrastructure vary significantly between Brazil, Mexico, Argentina, Colombia, and other nations. Sponsors must navigate country-specific requirements for remote monitoring, digital consent, and cross-border data governance.

Brazil leads the region with comprehensive ANVISA guidance and CONEP electronic consent standards. Other nations lag in formalizing equivalent regulatory frameworks. This asymmetry creates operational complexity for multinational trial sponsors. Ongoing dialogue among ANVISA, COFEPRIS, INVIMA, and other regional bodies is necessary to achieve true harmonization.

Frequently Asked Questions

Primary Sources

1. ANVISA. Collegiate Board Resolution – RDC No. 945 of 29 November 2024: Guidelines and procedures to conduct clinical trials in Brazil. Available at: gov.br/anvisa
2. CONEP. Ofício Circular No. 23/2022/CONEP/SECNS/DGIP/SE/MS: Normatização do uso de consentimento e assentimento eletrônico. Brasília, 17 October 2022. Available at: gov.br/conselho-nacional-de-saude
3. Carracedo S, et al. The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges. Pan American Journal of Public Health. Available at: journal.paho.org
4. Challenges and Opportunities for Cancer Clinical Trials Development in Latin America. JCO Global Oncology. 2025. DOI: 10.1200/GO-25-00383