As scientific knowledge, clinical experience, and acceptance of gene therapy products have evolved, so have the regulatory frameworks for ensuring the safety of these novel treatments. To date, there is no harmonized international standard for regulating gene therapy products; however,...
Expertise: Oncology & Hematology 104 results
Rare cancers account for 27 percent of all new cancer diagnoses in the U.S. and 22 percent of all new cancer diagnoses in the EU.1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges...
Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into...
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,...
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...