Clinical Research: Phase 1 - Phase 4

The Multi-Faceted World of Clinical Trial Matching in Precision Oncology Studies

The success of clinical trials is contingent upon finding participants who meet certain criteria, ensuring that the resulting study data are meaningful and relevant to the target patient population. Clinical trial matching is the process of identifying and connecting potential participants with studies that align with their specific medical condition and characteristics. In precision oncology,...

Clinical Research: Phase 1 - Phase 4

Vein-to-Vein Logistics in Cell Therapy: A Guide to Reducing Workflow Risk from Engineering to Patients’ Bedside

Cell therapy clinical trials are complex and successfully operationalizing these studies requires careful consideration of the interplay between the patient journey and vein-to-vein logistics workflow. In this guide, we explore key steps in executing a cell therapy clinical trial, from selecting the right sites to optimizing study retention. We also discuss the critical role of...

Medical and Regulatory Affairs

Rare Oncology and the FDA: Taking the Guesswork Out of Expedited Pathways

Rare cancers account for 25-30 percent of all new cancer diagnoses and 25 percent of cancer deaths.1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Faced with limited treatment options, researchers, clinicians, and patients may be...

Cancer Research is Complex. Let’s Navigate it. Together.

Supporting the journey from breakthrough science to new medical treatments. Hematology and oncology drug development has been transformed by the evolution of precision medicine, emerging therapies, and immuno-oncology. From small dose-finding studies to large, multinational trials, Premier Research offers cross-functional, customized solutions to meet you wherever you are in your development journey. To read more,...

Clinical Research: Phase 1 - Phase 4

Beyond Boundaries: Revolutionary CAR-T Therapies Pave Way to Conquer Solid Tumors

Chimeric antigen receptor (CAR) T-cell therapy is becoming an increasingly important part of the cancer treatment landscape, with a growing number of clinical trials investigating its use across a range of cancer types. To date, the FDA has approved six CAR T-cell therapies, all for hematological malignancies and all primarily used as treatments for patients...

Development Strategy

Premier Insight 283 | Rescuing a Phase 1 Oncology Trial: Long-Standing Experience Saves Study Momentum

Introduction For those who have been through it, a rescue study transition from one contract research organization (CRO) to another can be a difficult ordeal, often accompanied by logistical hurdles and communication challenges. When a sponsor of a Phase 1 dose expansion trial for a novel oncology therapy contacted Premier Research, they were more than...

Clinical Research: Phase 1 - Phase 4

9 Tips for Designing and Operationalizing Early-Stage Precision Oncology Studies

Traditionally, early-stage clinical trials focus on toxicity assessment and dose selection. Today, a growing number of Phase 1/2a trials are designed to draw inference about preliminary response rates due, in part, to the use of biomarkers and adaptive design approaches that enhance the early detection of efficacy signals. These approaches may add to study complexity...

Clinical Research: Phase 1 - Phase 4

Can Your Protocol Flex? The Importance of Adaptive Trial Designs in Precision Oncology Studies

Cancer is one of the most scientifically complex and dynamic diseases. Even with significant advances in our understanding of the genetic and molecular mechanisms that lead to cancer, only 10 percent of approved oncology drugs demonstrate an overall survival benefit.1 In recent years, there has been a shift in how early-phase oncology studies are conducted...

Clinical Research: Phase 1 - Phase 4

The Rise of Radiotherapeutics: Brief History and Best Practices for Clinical Trials

Radiation therapy was first used to treat cancer more than a century ago, and nearly half of all cancer patients still receive it at some point during their treatment.1 Historically, most radiation therapy was given by delivering ionizing beams of radiation from outside the body, but with advances in the field of nuclear medicine,  radionuclides...

Clinical Research: Phase 1 - Phase 4

Premier Perspective on Biomarkers in Oncology

In this era of precision medicine, biomarkers play a critical role in the rational development of novel therapies. With advances in both our understanding of cancer pathophysiology and tumor profiling technology, biomarkers can now be used to provide important insights at every stage of drug discovery and development. In this article, we explore the common...