Tag: early phase oncology

Clinical Research: Phase 1 - Phase 4

The Importance of Site Selection and Dosing Strategies in Early-Phase Oncology Studies

Setting up an effective phase one trial for a novel investigational oncology product is rife with challenges. Every aspect from site identification to estimation and coordination of enrollment and safety review is interconnected. Nuance is important. What factors can affect, or even derail, the timeline? Who are the key influencers and experienced sites? Does a...

Clinical Research: Phase 1 - Phase 4

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...

Patient and Stakeholder Engagement

The Art and Science of Selecting Patients for Phase 1 Oncology Studies

The primary purpose of early-stage clinical trials is to determine the recommended dose and toxicity profile of an investigational drug or multi-drug combination therapy. Since molecularly targeted agents (MTAs) and immunotherapies have toxicities that are distinct from cytotoxic chemotherapies, traditional dose escalation methods using toxicity-based endpoints may not be suitable for phase I studies of...

Clinical Research: Phase 1 - Phase 4

Key Considerations When Designing a Phase 1 Oncology Trial

Traditionally, phase 1 oncology trials have relied on a standard 3+3 dose escalation design to achieve the objective of defining a recommended phase 2 dose (RP2D). However, statistical simulations have shown that as few as one in three trials using the 3+3 design succeed in identifying the maximum tolerated dose.[1] Concerns have also been raised...