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Sub-Saharan Africa's Contribution to Clinical Trials in International Acute Coronary Syndromes and
Jonathan A Hudson1, Leah Sanga2, Modou Jobe3
1Kings College London BHF Centre, School of Cardiovascular and Metabolic Medicine & Sciences, London, United Kingdom.
Insights
Sub-Saharan African (SSA) populations are underrepresented in clinical trials informing European Society of Cardiology (ESC) guidelines for acute coronary syndrome (ACS) and heart failure (HF). South Africa is the only SSA country contributing, impacting guideline generalizability.
Area of Science:
- Cardiology
- Clinical Trials
- Global Health
Background:
- Sub-Saharan Africa (SSA) faces a growing burden of acute coronary syndrome (ACS) and heart failure (HF) with poorer outcomes compared to high-income nations.
- European Society of Cardiology (ESC) guidelines are crucial for evidence-based care, but their applicability to SSA populations is uncertain.
Purpose of the Study:
- To assess the representation of SSA populations in randomized controlled trials (RCTs) that inform ESC guidelines for ACS and HF.
- To analyze trends in SSA participation in these pivotal clinical trials over time.
Main Methods:
- Systematic analysis of pharmacotherapeutic RCTs contributing to the 2021 ESC HF and 2023 ACS guidelines.
- Data extraction from ClinicalTrials.gov, assessing trial inclusion of countries by World Bank income group, with a focus on SSA involvement and temporal trends.
Main Results:
- The vast majority of RCTs (75.9%) were conducted exclusively in high-income countries; none included low-income countries.
- South Africa was the only SSA country represented, contributing to 14.2% of HF and 8.2% of ACS RCTs.
- While HF RCTs involving SSA populations showed an increase (2.6% to 50% post-2020), ACS RCTs showed a decline after an initial rise (1.8% to 23.4% then 11.3%).
Conclusions:
- There is significant underrepresentation of SSA countries in pharmacotherapy RCTs for ACS and HF.
- The limited participation, primarily from South Africa, raises concerns about the applicability and generalizability of global ESC guidelines to diverse SSA populations.
Background:
There is a growing burden of acute coronary syndrome (ACS) and heart failure (HF) in sub-Saharan Africa (SSA), yet outcomes remain poor compared to high-income countries. The European Society of Cardiology (ESC) international guidelines are pivotal to the delivery of evidence-based care; however, their representation of populations from SSA remains unclear.
Objectives:
The purpose of the study was to evaluate the representation of populations from SSA in randomized controlled trials (RCTs) that inform ESC ACS and HF guidelines.
Methods:
We systematically analyzed pharmacotherapeutic RCTs contributing to the 2021 ESC HF and 2023 ACS guidelines, extracting data from ClinicalTrials.gov. We assessed the proportion of RCTs that included contributions from countries in each World Bank income group, focusing on the involvement of SSA countries and examining temporal trends.
Results:
Among the RCTs underpinning the ESC HF guidelines (n = 119) and ACS guidelines (n = 343), 75.9% were conducted exclusively in high-income countries. Middle-income countries were included in 22.2% of the trials, but none featured low-income countries. Within SSA, only South Africa was represented, contributing to 14.2% of HF and 8.2% of ACS RCTs. The number of HF RCTs involving populations from SSA has risen, from 2.6% in the 1990s to 50% post-2020 (P for trend< 0.05). For ACS RCTs, the proportion of trials involving populations in SSA increased from 1.8% pre-1990 to 23.4% during 2000 to 2009 (P for trend = 0.003), then declined to 11.3% in the following decade.
Conclusions:
There is a marked underrepresentation of SSA countries in ACS and HF pharmacotherapy RCTs. South Africa is the sole contributor from the region, which may affect applicability and generalizability of global guidelines to populations in SSA.
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