CER Daily Newsfeed

New CHEST Recommendations Guide Biologic Use for Severe Asthma

(1/20, Victoria Johnson, HCPLive) reports “...‘Given that there are currently no comparative effectiveness studies, nor is there a validated, commonly agreed definition of clinical response, biologic therapies can only be individualized in daily practice using indirect comparisons of data (delineated into conditional recommendations),’ [Amber J. Oberle, MD] and colleagues wrote in the guideline. ‘Decisions as to how to individualize biologic therapy should occur under a shared decision-making process that carefully considers underlying asthma comorbidities, T2 biomarkers, injection frequency, mode of administration, and access to resources.’” Full

From Evidence to Access: How Real-World Data Delivers for Patients

(1/20, Awny Farajallah, MD, PharmExec) comments “...At Takeda, large-scale RWE efforts in conditions such as narcolepsy and multiple myeloma have been crucial in informing trial design and endpoint selection, and in deepening our understanding of patient journeys. RWE enables us to more accurately illustrate how therapies perform in everyday settings across broad populations, thereby creating a fuller picture of a therapy's true clinical importance.” Full

Real World Evidence Can Guide Treatment for Advanced Prostate Cancer

(1/20, Sue Rochman, Kaiser Permanente) reports “...Patients with metastatic castration-resistant prostate cancer that did not progress when previously treated with the chemotherapy drug docetaxel may have better survival if they choose docetaxel again when they need a new treatment regimen rather than switch to the chemotherapy drug cabazitaxel, a new study published in JAMA Network Open suggests.” Full

Reflecting on 2025, Looking to 2026: Experts Predict the next Phase of Decision-Grade RWE

(1/21, Joanne Walker, The Evidence Base) reports “...Rachele Hendricks Sturrup (Duke-Margolis Institute for Health Policy) sees the FDA’s updated medical device RWE guidance as more than a usability tweak. In her view, it also points to a broader shift in what the agency will expect around oversight of RWD for all regulatory applications. ‘The US FDA plans to issue new guidance to align final RWD audit/inspection requirements within CDRH … with that of CDER and CBER,’ she told The Evidence Base. ‘The FDA says such inspection will no longer be required, provided the scientific merit of the study is high enough to not warrant source data inspection.’” Full