Gynecologic cancers are comprised of five major types: ovarian, uterine, cervical, vaginal, and vulvar. All women are at risk for these, and risk increases with age. Specific risk factors include a family history, human papillomavirus (HPV) infections (cervical cancer), genetic...
Expertise: Oncology & Hematology 102 results
Maximizing Oncology Study Outcomes: Protocol Development Considerations
Minimizing the burden that trial participants experience is essential for successful recruitment and retention, especially in oncology studies, where patients may need to be followed for years after the treatment phase of the trial. For sponsors, the process of optimizing...
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,...
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,...
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...
A biopharmaceutical company focused on delivering innovative products for women’s health chose us to manage their Phase 3 clinical trial evaluating an investigational, thermosetting, bioadhesive hydrogel for bacterial vaginosis (BV).
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...