Building a national collaborative network for developing randomized clinical trials on infectious diseases and antimicrobial resistance: A survey in Spanish hospitals

Abstract

Background

Antimicrobial resistance (AMR) is a global health challenge. Clinical trials are essential for evaluating novel and alternative therapeutic strategies. However, conducting randomized clinical trials (RCTs) in infectious diseases faces regulatory, logistical, and financial barriers, as well as challenges in patient recruitment. Collaborative research networks have demonstrated their effectiveness in overcoming these limitations. This study evaluates the capacity of Spanish medical centers to participate in RCTs on infectious diseases and AMR.

Methods

A structured feasibility survey was developed to assess infrastructure, research experience, patient recruitment potential, and willingness to collaborate in Spanish hospitals. Responses were collected using the REDCap platform and analyzed using Microsoft Excel, with results expressed as percentages.

Results

Of 90 centers contacted, 65 centers from 17 autonomous communities responded. The majority (78.5%) had dedicated infectious disease departments or units, and 36.9% reported over 1000 annual hospital admissions for infectious diseases. Research experience was strongest in antimicrobial-resistant Gram-negative (84.6%) and Gram-positive bacteria (78.5%). Phase II–IV RCTs were the most conducted trials, predominantly funded by private sources. While 75.4% of centers reported available human resources for research, specialized roles such as project managers (18.5%) and monitors (12.3%) were less common. Notably, 90% of centers expressed willingness to participate in a collaborative network for conducting unfunded RCTs.

Conclusions

The results highlight Spain's strong research infrastructure and expertise in infectious diseases, providing a solid foundation for establishing a national collaborative clinical trials network. However, variations in specialized research personnel and the low frequency of academic trials indicate areas for improvement.