The research project is a component of work done by Icon and the Foundation for the National Institutes of Health Biomarkers Consortium (FNIH BC) on behalf of the FDA.
The work aims “to support the development of safe and effective antibacterial treatments in areas of unmet need in infectious disease,” Brittany Erana, Senior Director, Clinical and Scientific Research, Icon Commercialization and Outcomes, told us.
The relationship dates back to 2012 and the development of patient-reported outcome (PRO) measures for use with patients diagnosed with community-acquired bacterial pneumonia (CABP) acute bacterial skin and skin structure infections (ABSSSI).
In 2014, the FDA funded the development of a third PRO measure for patients diagnosed with hospital-acquired bacterial pneumonia (HABP).
Erana explained, “All three instruments have been designed to accurately and comprehensively assess the symptoms of each disease area at various time points over the course of the infection."
Antibacterial drugs trials
"Despite the high mortality and morbidity of these conditions, sponsors engaged in this clinical research do not currently have a consistent methodology to assess primary endpoints, which can slow development and ultimately delay delivery of medicines to patients,” Erana said.
However, the PROs currently in development could help define endpoints that can provide direct evidence of treatment benefits.
“When developed appropriately, they can increase the efficiency and clinical relevance of clinical trials,” Erana explained.
Clinical outcomes assessment
While the Clinical Outcomes Assessment (COA) Scientific Research team at Icon has validated the three instruments, Erana explained the most recently awarded component – which Icon announced last week – is a capstone to the project.
“This project involves the design and execution of a psychometric validation study aimed at evaluating the psychometric properties of all three instruments,” she said.
Specifically, once psychometric validity is shown, the three instruments will improve the clinical endpoints for trials in areas where optimal endpoints are lacking.
Moving forward, the team will design and execute a psychometric validation study for the three PRO instruments in accordance with the FDA guidance for PRO measures used to support labeling claims (FDA PRO Guidance, 2009).
The project will be performed in line with the Drug Development Tool (DDT) Qualification Program (Qualification DDT Draft Guidance, 2010).
Additionally, the measures will be adapted for administration via electronic clinical outcomes assessment technology (eCOA).
“As the PRO instruments are in the final stages of development, the eCOA system is being developed in parallel,” Erana explained.
The company is currently recruiting sites and patients to participate in the psychometric validation research stage. Once the eCOA system is developed, the handheld device and web portal will be available for use in the research study.
“This technology will allow the patients to answer the questionnaire on a handheld device at specified time points over the course of the infection in order to measure the effects of antibacterial drugs,” explained Erana.
“Once the measures are psychometrically validated, it is intended for each measure to be used as a standard tool to gather key endpoint data on future clinical researcher in each of the respective indications.”