Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

Considerations to Improve Patient Outcomes in Early Drug Development

Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes. Topics in this...

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 3, 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

Gaining Patient Input: How to Ensure Patient Interests Remain Top of Mind

Our focus on women’s health research means we’re sensitive to the concerns and needs of the female volunteers contemplating clinical trial participation. In order to effectively enroll women, it’s important to acknowledge these volunteers and consider their perspectives in every step of the clinical research process. Regularly engaging women, their physicians, and health advocates helps...

Clinical Research: Phase 1 - Phase 4

Teaming Up with Sites During Trial Design

According to the Tufts Center for the Study of Drug Development (Tufts CSDD), nearly half of all clinical studies require substantial—and potentially avoidable—protocol amendments that lengthen timelines and increase costs. Tufts CSDD also notes that more than half of the substantial amendments are implemented during the study enrollment period, mainly due to difficulties in recruiting...

Clinical Research: Phase 1 - Phase 4

Designing Trials for Patients

Clinical development is about finding new healthcare solutions that improve patient lives. This starts with identifying what matters most to people as they manage their health and wellbeing. Appropriate use of patient input can help improve development and regulatory decisions. Listening to patients living with a condition, we can proactively address potential flaws in clinical...