Rare cancers account for almost a quarter of all new cancers worldwide though there is no universally adopted definition for rare cancers. In the U.S., rare cancers are defined as those with fewer than 15 cases per 100,000 per year,...
Expertise: Oncology & Hematology 102 results
Oncology & Hematology
Resources for Childhood Cancer Awareness Month
Premier Research is dedicated to helping patients and families around the world overcome the burden of debilitating diseases, such as a cancer diagnosis. Cancer is a leading cause of death for children and adolescents, and there are approximately 300,000 children...
Oncology & Hematology
Regulatory Challenges in Global CAR-T Cell Therapy Development
When exploring the complex and rigorous regulatory landscape for CAR-T cell therapies, sponsors may encounter challenges in their efforts to bring products to market Since the historic approval of Kymriah® (tisagenlecleucel) in 2017, research on chimeric antigen receptor (CAR) T...
Oncology & Hematology
Considerations for Applying Adaptive Design Approaches to Early Oncology Studies
By utilizing accumulating data to modify the operating characteristics of an active trial in accordance with pre-specified rules, adaptive designs can make clinical trials more flexible, efficient, and informative than fixed-sample designs.1 Adaptive design approaches can be applied across all...
Oncology & Hematology
Minimizing Early-Stage Oncology Failures with Adaptive Design Approaches
Despite advances in our understanding of the complex genetic, molecular, and immunological factors which lead to cancer, the success and likelihood of approval rates for oncology remain low. According to a recent study performed by the Biotechnology Innovation Organization (BIO),...
Oncology & Hematology
Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines
Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer.
Oncology & Hematology
Med Ad News – Optimizing Early Oncology Studies Through Adaptive Trial Designs
Despite advances in technology and our understanding of the genetic and molecular underpinnings of cancer, making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. In fact, a recent review revealed...
Oncology & Hematology
iPSP Considerations for Molecularly Targeted Cancer Drugs
With the passage of the Pediatric Research Equity Act (PREA) of 2003, drug manufacturers were required to submit an initial pediatric study plan (iPSP) prior to commencement of Phase 3 studies (or new drug application [NDA]/biologics license application [BLA] submission...
Oncology & Hematology
5 Things to Know About the FDA RACE for Children Act
The Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients by mandating that all new adult oncology drugs also be tested in children when the molecular targets are...
The Research to Accelerate Cures and Equity (RACE) for Children Act The Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients by mandating that all new adult oncology...