Assessing the adoption and impact of decentralized clinical trial approaches in Africa: a multi-country survey

Abstract

<title>Abstract</title> <bold>Background</bold> Decentralized clinical trials (DCTs) are increasingly promoted as a digital and remote health research strategy to improve trial recruitment, retention, diversity, and overall efficiency. However, evidence on their adoption and feasibility in African settings remains limited. We aimed to assess the adoption and impact of DCT approaches in Africa. <bold>Methods</bold> We employed a cross-sectional descriptive-analytic survey design to collect and analyze data from clinical research stakeholders directly involved in trial implementation, oversight, and support in Africa. Using a structured questionnaire, participants reported on the DCT components they implemented and associated challenges, opportunities, and recommendations for use in Africa. We cross-tabulated frequencies to generate an 8 x 8 contingency matrix representing eight DCT components and eight perceived advantages, and we used Pearson chi-square (X ² ) tests of independence to analyze the association between the two, with standardized residuals (&gt;│2│) indicating over- or under-represented associations. <bold>Results</bold> We received responses from 91 participants in 31 countries, with 75 (83.3%) based in Africa and mostly affiliated with clinical trial sites or research centers (55; 67.9%) and contract research organizations (15; 18.5%). Participants identified 90 advantages, 78 challenges, and 30 recommendations related to DCT implementation in Africa. Major advantages included improved patient access to trial sites (25; 27.8%), faster data availability (19; 21.1%), and reduced administrative burden (12; 13.3%), while the main challenges were related to technology (17; 21.8%), infrastructure (16; 20.5%), and digital literacy (12; 15.4%). Recommendations most frequently favored direct data entry (36; 92.3%), remote study visits (31; 81.6%), and electronic source data (31; 81.6%). The analysis revealed 151 links between DCT components and perceived advantages across the eight categories, with a significant association and non-uniform distribution of advantages among DCT components (X ² = 78.6, df = 49, <italic>p &lt; 0.01</italic> ). Direct data entry contributed the largest share of advantages (38; 25.2%) and overrepresentation (standardized residuals &gt; + 2.0), especially for faster data availability, improved data quality, and reduced administrative burden. <bold>Conclusion</bold> DCTs are increasingly used in Africa, but adoption and benefits vary by component, with foundational, data-centric elements more widely implemented than advanced, participant-centric elements, such as wearable devices and direct-to-patient investigational medicinal products, due to technological, logistics, and regulatory constraints. Equitable scale-up requires a context-adapted approach supported by workforce capacity, regulatory alignment, and digital infrastructure.

Ähnliche Arbeiten