RWE Shows that Short-Course Antibiotic Treatment is Better and Safer
(Thursday, November 11, 2021)
Real world data (RWD) and the resulting real world evidence (RWE) can provide unique and valuable information, otherwise hard to generate, on best practices for patient treatment in real-world health care settings. FDA supported two RWD studies, one in adults and the other in pediatric populations, to evaluate the duration of the antibiotic treatments for bacterial infections. Both studies involved extraction of patient-level data from the electronic medical records (EMR) collated from five hospitals within the John Hopkins Health System. Diverse data elements were collected such as demographics, pre-existing medical conditions, severity of infection, source and source control measures, microbiological data, antibiotic treatment data, and clinical outcomes. The first study evaluated antibiotic treatment for Pseudomonas aeruginosa bloodstream infections in adults, and the other study studied antibiotic treatment for pyelonephritis, an upper urinary tract infection, in children 6 months to 18 years of age. In both cases, it was found that the shorter-course antibiotic treatment was equally effective as the longer-course one with fewer side effects and fewer incidences of antibiotic resistance. Based on the studies the researcher recommended a 7-day versus 14-day course for adults, and a less than 10 day-course versus greater than 10 day-course for children. These studies offer a proof of concept of the value of RWD and RWE to inform treatment options. FDA has published a few guidance documents and announced policies to support the use of RWD/RWE for not only making clinical decisions but also for product approval. Over the last 5 years, RWD/RWE have been used for regulatory decisions by FDA for several medical devices, drugs, and biologics. These data are particularly invaluable for finding new uses of previously approved products, generating new benefit-risk data to be used for refining clinical best practices and supporting reimbursement decisions, and reducing avoidable risk of over medication like in the above case of longer-course antibiotic treatment when a shorter one is equally good and may even be better. Similar data could be valuable for products intended for neurological indications, chronic diseases, and pediatric diseases, among others. There is lot more to come from this field of data analysis as shown by these early studies.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC