During the initial planning for clinical trial implementation, intense focus is placed on strategies for patient recruitment, while strategies for patient engagement and retention are often left until after the treatment phase. However, with many current protocol designs in oncology,...
Expertise: Oncology & Hematology 107 results
Oncology & Hematology
Opportunities Beyond Hope: Immuno-Oncology Drug Development
Over the past decade, immuno-oncology (IO) has become one of the most promising and fastest-growing areas of cancer research and drug development. Present-day advances in immuno-oncology can be attributed to an explosion of research in this area in recent years,...
Oncology & Hematology
Enhancing Clinical Trial Accessibility – Bringing Oncology Trials to Patients
https://soundcloud.com/premier-research/premier-voices-15-bringing-the-trial-to-the-patient In recent years, we have seen a shift toward decentralized and hybrid clinical studies that help bring clinical trials to patients and reduce the burden of study participation. COVID-19 accelerated this shift, increasing emphasis on patient access, safety, and...
Oncology & Hematology
Phase 1 Trials: Strategies for Site Selection and Dose-Escalation
Designing and executing an effective Phase 1 trial for a novel investigational oncology product can be challenging. Every facet of the process, from site selection and recruitment rate analysis to trial design and start-up, is interconnected. A nuanced approach is...
Patient recruitment comprises one of the most significant initial challenges in any oncology study, but engaging and retaining patients throughout the trial can prove to be the challenge requiring the most up-front planning and coordination. However, during the initial planning...
Immunotherapy has led to substantial advances in cancer therapy in recent years. Still, unpredictable response rates and immune-related adverse events have hampered the widespread use of immune checkpoint therapy to treat cancers. To tackle these challenges, sponsors are increasingly looking...
Cell & Gene Therapy
A Primer on Cancer Immunotherapy Part 1: Goals & Major Approaches
In recent years, immunotherapy has led to substantial advances in cancer therapy. In particular, the immune checkpoint inhibitors — PD-1/PD-L1 and CTLA-4 inhibitors — have revolutionized treatment for certain hematologic malignancies and solid tumors. The U.S. Food and Drug Administration...
Beginning in 2017 with the approvals of tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™), chimeric antigen receptor (CAR) T-cell therapies have changed the treatment paradigm for patients with certain hematologic malignancies. Since those initial approvals, three other CAR T-cell therapies have...
Chimeric antigen receptor (CAR) therapies use CAR T cells, a patient's own immune cells that are programmed to recognize and kill cancer cells throughout the body. Beginning in 2017 with the approvals of tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™), CAR...
Oncology & Hematology
New FDA Draft Guidance Provides Insights on Use of PROs in Oncology Trials
Incorporating patient-reported outcomes (PROs) into clinical trials can help sponsors better understand patients’ symptoms and how a therapy will affect their quality of life, and these insights can be particularly valuable in oncology research. However, there has been a lack...