Retrospective on global pulmonary hypertension clinical trials: 1999-2021

Area of Science:

• Cardiology
• Clinical Trials
• Public Health

Background:

• Comprehensive analyses of global pulmonary hypertension (PH) clinical trials are notably sparse.
• Understanding the landscape of PH research is crucial for addressing global health disparities.

Purpose of the Study:

• To analyze the characteristics and trends of PH clinical trials registered globally from 1999 to 2021.
• To identify differences in trial participation and design between developed and developing countries.

Main Methods:

• Extracted data from ClinicalTrials.gov for PH trials registered between 1999 and 2021.
• Analyzed trial information including country participation, intervention type, PH categories, sponsorship, study phase, design strategies, and participant demographics.

Main Results:

• 203 PH trials involving 23,402 participants were analyzed; 67.8% were female.
• Most trials focused on drug interventions (95.6%) for Group 1 PH (76.3%), primarily sponsored by industry (59.5%).
• Developing countries showed higher participation in multinational trials with larger sample sizes and distinct intervention/design strategies.

Conclusions:

• Global PH research progress is uneven between developed and developing countries.
• Women and children with PH exhibit unique characteristics and warrant greater research focus and attention.
• Disparities in PH trial participation and design necessitate targeted strategies to improve global equity in research.