The US Food and Drug Administration has rejected Eiger BioPharmaceuticals’ request to meet with the agency regarding peginterferon lambda, its repurposed hepatitis D treatment for use in COVID-19. The company asked for the meeting to discuss an emergency use authorization in September based on data […]
The Disconnect Between Clinical Trial and Real-World Populations Holds Back Oncology Care
Randomized controlled trials (RCTs) are the gold standard for regulatory approval. However, cancer trial participants are often not representative of real-world patient populations. As a result, patient outcomes may not mirror those found in trials. In a new article published on OncLive, Maurie […]
External Control Arms as a Substitute for Placebo Groups
While randomized controlled trials (RCTs) are the gold standard format of clinical trials, the need for a placebo group can extend development or even render their use impossible for rare diseases with small patient populations. The use of existing real-world data (RWD) and real-world evidence (RWE) […]
Lecanemab May Avoid Aduhelm’s Fate With CMS
New data from Eisei suggests that its Alzheimer's drug lecanemab may not share the same fate as aduhelm, which was pulled from the market after the Centers for Medicare and Medicaid Services (CMS) agreed to only reimburse the drug for patients in randomized clinical trials. The results show that the […]
Webinar: Avoid The Valley of Death – Increase Confidence in Translational Research Using Biosimulation – September 12th
Only a third of preclinical programs make it to Phase 1 trials. Honing translational research is key to reducing the substantial financial risk associated with drug development. A new tool to help narrow the focus of preclinical programs is physiologically-based pharmacokinetic modeling (PBPK) […]
Using Real-World Data to Boost Clinical Trial Patient Diversity
The patient population of clinical trials currently and historically have rarely represented the demographics of the general population. Real-world data (RWD) is increasingly being used to help address these disparities in trial participation. RWD sources are often far more diverse than patient […]
Webinar: Overcoming Patient Recruitment Challenges in Rare Disease Trials
Nearly 450 million people live with rare diseases globally. This diverse population needs treatment options, but clinical trials are made difficult by the small number of people living with a given disease. As a result, effective recruitment strategies are more critical than ever. In a new webinar […]
Webinar: Overcoming Patient Recruitment Challenges in Rare Disease Trials – September 28th
Patient recruitment is one of the most difficult parts of any clinical trial, but it’s even tougher when studying therapeutics for rare diseases. In an upcoming webinar taking place on September 28th, speakers will discuss the unique challenges of patient recruitment in the field, how to speed up […]
Whitepaper: Making APAC the Oncology Clinical Trial Destination
A new whitepaper from Premier Research makes the case that the Asia-Pacific (APAC) Region is the hot spot for oncology clinical trials. Currently, APAC stands as the region with the most ongoing oncology trials worldwide, with the number of active trials growing 138% over the last 10 years. In the […]
Using Just-in-Time Clinical Trials to Address Disparities in Clinical Trial Representation
Finding and enrolling patients for clinical trials is one of the most difficult, time-consuming, and expensive parts of the drug development process. Ensuring that the patients represent the diversity of the population is even harder. In a new Targeted Oncology article, Kashyap Patel, MD, and […]
