Perpetual observational studies: new strategies to support efficient implementation of observational studies and randomized trials in infectious diseases

In a new peer-reviewed paper*, a team of leading infectious disease experts makes a convincing case for a novel concept in clinical research: Perpetual Observational Studies (POS). This alternative approach is part of Ecraid’s efforts to improve clinical research in infectious diseases. 

The world faces an increasing threat of emerging infectious diseases and evolving antimicrobial resistance (AMR). A recent report estimated that there were around five million deaths associated with bacterial AMR globally in 2019, although significant knowledge gaps exist. During the COVID-19 pandemic, the world witnessed the impact of an emerging infectious disease with pandemic potential. It highlighted the importance of preparedness in healthcare systems in terms of a prompt and coordinated scientific research response to mitigate the pandemic’s consequences. 

In order to identify optimal treatment strategies for (drug-resistant) infectious diseases, randomized intervention studies are preferred, yet challenges exist in conducting clinical research in this domain. Patient recruitment is complex; diagnosis and treatment windows are small and often precede microbiological identification of the causative pathogen and its antibiotic susceptibility profile. This precludes rapid acquisition of high-quality evidence and slows down the development of novel pharmaceutical treatments.  

Enhancing the efficiency of research in infectious disease is needed to contend with emerging antimicrobial resistance and the slow development of new treatment options. In recent years, designing and conducting clinical studies in infectious diseases have evolved through the development and implementation of innovative methods.

Improving clinical research

A peer-reviewed report* recently published in Clinical Microbiology and Infection introduces a new concept in clinical research: Perpetual Observational Studies (POS). POS are prospective, observational clinical studies aiming to enrol patients on a perpetual basis to collect a minimal set of data, mostly available through routine care, as described in a core protocol. POS are planned to serve as the backbone to clinical research that will enable the efficient design and implementation of ‘plug-in’ intervention and observational trials.  

Implementation of POS will promote high-quality and efficient research compared to conventional research. It is based on a network of sites with experienced research staff. Data collected within POS can inform study planning in terms of study site-selection, study feasibility and timelines. Ecraid’s extensive research infrastructure can provide a wide range of expertise needed for study planning and execution. POS will help produce high-quality burden data for infectious syndromes. 

Lead author Dr. Nasreen Hassoun-Kheir from the Geneva University Hospitals (Hopitaux Universitaires de Genève) said:

Within the ECRAID-Base project, five POS studies have been set up as a basis for advanced research on diagnosis, treatment and prevention of infectious diseases. The studies focus on patients with ventilator associated pneumonia, complicated urinary tract infections, inpatients and outpatients with acute respiratory infections, and infectious disease syndromes among immunocompromised patients admitted to the hospital. The hope is that the POS research concept will enhance the quality and the feasibility of studies on prevention, diagnosis, treatment or clinical outcomes of infectious diseases in the era of emerging infectious diseases and antimicrobial resistance. 

Learn more about the five POS studies currently running: POS-VAP, POS-cUTI, POS-ARI-ER, POS-ARI-PC and POS-Diseases X. 

* An open-access, pre-print version of the paper is available here.