Patient-reported outcomes (PRO) offer valuable post-market insight for drug and medical device manufacturers, but they can also be leveraged to provide input into practices that can enhance treatment development during the course of a clinical trial. ICON's own Todd Saretsky recently presented a poster at the FDA's 2015 Office of Regulatory Science and Innovation Symposium
which addresses the potential of developing a standardized PRO tool to measure treatment effects in Hospital-Acquired Bacterial Pneumonia (and will present similar work at ISPOR in Philadelphia). This work is being overseen by ICON Directors Kellee Howard and Sarah Clifford and members of FNIH.
Titled 'Signs, Symptoms, and Existing Patient-Reported Outcome (PRO) Measures in Hospital-Acquired Bacterial Pneumonia (HABP): A Comprehensive Literature Review,' the poster examined data pulled from MEDLINE and EMBASE databases, ultimately focusing on six specific studies that met inclusion criteria. The results of the analysis revealed that current HABP clinical trials have not considered symptoms and health-related quality of life in the evaluation of treatment efficacy. Furthermore, no PRO instruments assessing HABP symptoms have been developed. The ICON team in conjunction with FNIH also discovered that very few articles have focused exclusively on HABP, as authors typically grouped HABP with other forms of nosocomial pneumonia or community-acquired pneumonia and healthcare-associated pneumonia.
The poster identified the most frequent signs and symptoms associated with HABP, including fever, cough, purulent sputum, dyspnea, rales, chest pain, elevated respiratory and heart rate, and elevated white blood cell count. It also stated that the HABP literature has historically focused on clinical global impressions of change to evaluate treatment efficacy and there is currently limited evidence assessing the impact of antibiotic therapies on patient-reported symptoms in HABP patients. The conclusion describes the importance of developing clinically relevant endpoints in accordance with FDA PRO Guidance when evaluating antibacterial drugs intended to treat HABP.
The original poster is available to download
from the ICON website.