CER Daily Newsfeed

Using Real-World Data to Improve Patient Access to Oncology Therapies

(10/9, Carolyn Zele, Biopharma Dive) comments “...In some cases, RWD might reveal that a manufacturer’s payer contracting hasn’t resulted in the expected level of access, as a competitor is receiving preference on the pathway at the most common treatment facilities...Also, for drugs that are left off of a clinical pathway, integrated RWD can help manufacturers persuade pathway influencers to reconsider their stance.” Full

Why Linking Clinical Trials to Real-World Data Is the Critical next Step for Medical Device Development

(10/Mehdi NajafZadeh, Medical Design & Outsourcing) comments “...Linking clinical trial data to RWD at the patient level can help medical device manufacturers develop a deeper understanding of the longitudinal patient journey than ever before. Regulators are enthusiastic to link clinical trials to RWD to reduce gaps in insights and evidence. Said FDA Commissioner Dr. Robert Califf at the 2023 J.P. Morgan Healthcare Conference: ‘It’s not hard to imagine that the combination of the patient’s medical record and the use of digital technologies at home would give a much better portrait of what’s going on with a human being than going to a research clinic once every three months and having a study coordinator try to figure out what happened during that intervening period.’” Full

How Payer-Participating Trials Could Help Transform Clinical Research on FDA-Approved Drugs

(10/6, Vijay Ramakrishnan, STAT Plus) comments “...Unlike patient registries or real-world evidence trials, payer-participating trials aim to collect patient-specific clinical data, including blood-based immune biomarkers, in stratified patient subsets. Such data could yield critical insights into clinical responses and guide treatment decisions for these therapies, which share two common immune mechanisms: one facilitating beta-amyloid plaque clearance, and the other causing brain bleeding and swelling. Through patient stratifications, excellent clinical responders and those at higher risk for adverse effects could be identified.” Subscription Required

Germany: Clinical Trials: Two Arms Are Better than One, Says IQWiG

(10/9, The Pharma Letter) reports “...Beate Wieseler, head of the IQWiG’s Drug Assessment Department, notes: ‘The FDA clearly states that the likelihood of demonstrating the effectiveness of a drug with an external control is low, and strongly recommends a study design with an internal control - also for rare diseases. In addition, the FDA designates specific situations where externally controlled studies are generally not suitable, for example when the natural history of the disease is not well known or the disease course is variable. The EMA should include these points in its reflection paper.’” Subscription Required