Logo Image
|Videos|August 30, 2016

Minimizing the Gap Between Clinical Trial Data and Real-world Outcomes

Romney Humphries, PhD, D(ABMM), section chief of Clinical Microbiology at the University of California, Los Angeles, discusses the importance of minimizing the gap between clinical trial data and real world outcomes.

Romney Humphries, PhD, D(ABMM), section chief of Clinical Microbiology at the University of California, Los Angeles, discusses the importance of minimizing the gap between clinical trial data and real world outcomes.

Interview Transcript (slightly modified for readability)

“I think that as diagnostic manufacturers are developing these technologies, it’s really important for them to keep in mind that they need to have a clinical outcome portion to their trials.

Currently, trial design for in vitro diagnostic devices in the United States is predominantly comparing method A to method B in the lab, but it doesn’t always, or really ever, step outside the lab to look at what could potentially happen with the patient with this test. I think through either clinical trials or follow-up studies, we need to have these real world studies to evaluate randomizing patients to standard of care versus rapid diagnostics and how that impacts the overall outcomes and cost associated with the care of these patients.”

Related to this article

View more
Cefiderocol Continues to Show Activity Against Resistant Gram-Negative Infections
Cefiderocol Continues to Show Activity Against Resistant Gram-Negative Infections
Shionogi data presented at IDWeek 2026 demonstrated a 76.7% clinical response with cefiderocol in carbapenem-resistant respiratory infections and high in vitro activity against resistant P aeruginosa VAP isolates. Christine Slover, PharmD, vice president, Infectious Diseases US Medical Affairs, Shionogi, offers insights on the data as well as clinical considerations for providers when weighing the antibiotic for patients.
Read more
Household Contacts Drive Most Hepatitis B Exposures in Young Children
Household Contacts Drive Most Hepatitis B Exposures in Young Children
Karen B. Jacobson, MD, MPH, of Kaiser Permanente Northern California, presented data at IDWeek 2026 showing 58.2% of children younger than five years exposed to active hepatitis B in the home were exposed by someone other than their birth mother, a risk maternal screening alone would miss under the CDC’s revised birth dose recommendation.
Read more
ID Week Highlights Part 1
ID Week Highlights Part 1
In this first IDWeek 2026 roundup, oral olorofim matched AmBisome in invasive aspergillosis, aztreonam-avibactam held activity as MBL-producing CRE rose, pritelivir cut hospitalizations in refractory HSV, and zelicapavir shortened RSV symptoms in high-risk adults.
Read more
Pfizer 25-Valent Pneumococcal Vaccine Boosts Serotype 3 Response in Infants
Pfizer 25-Valent Pneumococcal Vaccine Boosts Serotype 3 Response in Infants
Alejandra Gurtman, MD, discussed the phase 2 data at IDWeek 2026 which showed the investigational 25-valent pneumococcal conjugate vaccine 25vPnC produced serotype 3 antibody levels about 15-fold higher than Prevnar 20 after the booster dose, targeting a serotype still behind 10.6% of invasive pneumococcal disease in US children younger than five years.
Read more