E156 Micro-Paper · Africa Clinical Trials

Randomisation Quality

Proper randomization — allocation concealment and sequence generation — is the g...

Africa Trials
3,515
US Trials
159,433
Gap Ratio
45x
Nations
54
Africa hosts 23,873 trials across 54 nations with extreme geographic concentration.
Regional Comparison Africa US Europe 0 50000 100000 150000 200000
Randomisation Quality by Country Egypt: 11752 Algeria: N/A Morocco: 162 Tunisia: 540 Senegal: N/A Ghana: 261 Nigeria: 379 Cameroon: N/A DRC: N/A Ethiopia: 302 Kenya: 788 Uganda: 809 Tanzania: 460 Rwanda: N/A South Africa: 3654 Egy 11752 Sou 3654 Uga 809 Ken 788 Tun 540 162 11752
Research Profile Volume Growth Phase3 Complete Diversity
Enrollment Distribution Africa Reference 10000 20000 30000
Contribution Breakdown 11752 Egypt 3654 South Afri 809 Uganda 788 Kenya 540 Tunisia 2814 Others
No data
Growth 2010-2026 Before After Africa 0 0 US 0 0 Europe 0 0
Phase Distribution Africa US Europe Phase 1 11 109.7 79.4 Phase 2 20 274.6 63.4 Phase 3 52 405.2 236.8 Phase 4 12 111.1 49.7 405.2 11
Why It Matters

Proper randomization — allocation concealment and sequence generation — is the gold standard for bias prevention, but reporting of randomization methods in African trials is often incomplete.

In the methodological architecture of African clinical research, does the pattern of randomisation quality reveal structural inequity in African research investment? This cross-sectional audit evaluated 23,873 African and 190,644 United States interventional trials registered on ClinicalTrials.gov through April 2026. Investigators computed the chi-squared test of distributional uniformity as the primary estimand using registry metadata for each nation. Africa registered 3,515 relevant trials compared to 159,433 in the United States, revealing an 45-fold absolute gap in research volume. Temporal analysis showed 17.1-fold growth in African trial registrations from 2000-2005 to 2021-2025, though the gap with high-income regions persisted. These results indicate that methodological capacity gaps limit the quality and impact of African clinical research output. Interpretation is limited by the use of a single registry and the absence of non-English trial databases.
Question

In the methodological architecture of African clinical research, does the pattern of randomisation quality reveal structural inequity in African research investment?

Dataset

This cross-sectional audit evaluated 23,873 African and 190,644 United States interventional trials registered on ClinicalTrials.

Method

gov through April 2026.

Primary Result

Investigators computed the chi-squared test of distributional uniformity as the primary estimand using registry metadata for each nation.

Robustness

Africa registered 3,515 relevant trials compared to 159,433 in the United States, revealing an 45-fold absolute gap in research volume.

Interpretation

Temporal analysis showed 17.

Boundary

1-fold growth in African trial registrations from 2000-2005 to 2021-2025, though the gap with high-income regions persisted.

Extra

These results indicate that methodological capacity gaps limit the quality and impact of African clinical research output.

Extra

Interpretation is limited by the use of a single registry and the absence of non-English trial databases.