Oncology & Hematology

Clinical Research: Phase 1 - Phase 4

Challenges and Opportunities in Gynecologic Cancer Research: Excerpts from a Round Table Discussion

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 mutations such as BRCA1 and BRCA2 (ovarian cancer or OC), and hormone replacement therapy. Early...

Clinical Research: Phase 1 - Phase 4

Empowering Oncology Patients to Maximize Study Outcomes (Australia)

March 3, 2022 | 2:00pm AEDT Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during the initial planning stages of clinical trial implementation, the focus is usually...

Clinical Research: Phase 1 - Phase 4

Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies

Phase 1 clinical trials aim to determine the maximum tolerated dose (MTD) of a new molecule with the goal of identifying a recommended Phase 2 dose (RP2D), often the MTD itself. Ideally, the RP2D would have adequate therapeutic effect to demonstrate preliminary signs of efficacy in Phase 2, but many Phase 2 trials fail to...

Clinical Research: Phase 1 - Phase 4

Empowering Oncology Patients to Maximize Study Outcomes: Strategies and Considerations for Sponsors

Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during the initial planning stages of clinical trial implementation, the focus is usually placed predominately on recruitment and not on patient...

Clinical Research: Phase 1 - Phase 4

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 study outcomes involves a deep understanding of the patient’s care journey and a deliberate effort...

Clinical Research: Phase 1 - Phase 4

Empowering Oncology Patients to Maximize Study Outcomes

February 24, 2022 | 10:00am EST Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during the initial planning stages of clinical trial implementation, the focus is usually...

Clinical Research: Phase 1 - Phase 4

Empowering Oncology Patients: Recruitment and Retention Strategies for Optimizing Study Outcomes

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, trial endpoints require study participants to be followed for years to evaluate side effects and...

Clinical Research: Phase 1 - Phase 4

Opportunities Beyond Hope: Immuno-Oncology Drug Development

Introduction 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, leading to a paradigm shift in the understanding of cancer. Until the late 1990s...

Clinical Research: Phase 1 - Phase 4

Drug Development & Delivery: Navigating the Evolving Landscape of Rare Cancer Trials

Rare cancers account for 27% of all new cancer diagnoses in the US and 22% of all new cancer diagnoses in the EU. With the shift toward grouping cancer based on molecular subtypes rather than by location and tissue type, some common cancers are now categorized as groups of rare cancers. For example, melanoma as...

Clinical Research: Phase 1 - Phase 4

PREMIER VOICES #15: Enhancing Clinical Trial Accessibility – Bringing Oncology Trials to Patients

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 engagement. Now, proactively incorporating...