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, whereas in the EU, they are defined as six cases per 100,000 per year. Historically,…
Expertise: Oncology & Hematology 82 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 diagnosed with cancer each year around the world.1 With the help of better therapies, more…
Oncology & Hematology
Regulatory Challenges in Global CAR-T Cell Therapy Development
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 phases of clinical development, including early oncology studies. These designs introduce real-time flexibility while a…
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), nearly one-third of drugs entering phase 2 studies between 2006 and 2015 failed to progress….
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 that, among 59 cancer drugs approved by the U.S. Food and Drug Administration (FDA) based…
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 in the absence of a Phase 3 study) for studies involving a new active ingredient,…
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 relevant to a particular childhood cancer. Enacted August 18, 2017, as part of the Food…
Oncology & Hematology
Contract Pharma – Realizing the Full Potential of Precision Medicine in Oncology
Innovation in oncology drug development is being driven by “precision medicine.” Precision medicine promises a new paradigm in oncology where every patient receives truly personalized treatment. This approach to disease diagnosis, treatment and prevention utilizes a holistic view of the patient—from their genes and their environment to their lifestyle—to make more accurate decisions. Growing at…