Oncology & Hematology

Clinical Research: Phase 1 - Phase 4

Patient-Centered Hematological Malignancy Trials: A Blueprint for Success

Hematological malignancies are a diverse group of cancers that affect the blood, bone marrow, lymph nodes, and spleen. The complexity and variability of these diseases demand innovative and personalized approaches to treatment that traditional clinical trial methodologies often lack. Designing patient-centric hematology clinical trials requires a comprehensive understanding of the patient experience, coupled with a...

Getting It Right from the Start: 10 Essentials for Designing Biomarker-Guided Oncology Clinical Studies

In the field of oncology, as we got better at understanding the changes that occur in cancers at a molecular level, we have seen a shift towards precision medicine. Biomarkers are central to this change and can be leveraged to provide important insights at every stage of drug development. By advancing our understanding of cancer...

Operationalizing Biomarker-Guided Oncology Trials: Planning for Success

Advances in genomic and proteomic technologies have led to the identification of numerous biomarkers with potential clinical utility in oncology, including gene mutations, gene amplifications, gene expression signatures, and altered proteins. To date, more than 1,500 potential oncology biomarkers have been identified in the preclinical setting. Among these, approximately half are being studied in active...

Tuning Into Radiotherapeutics: Considerations for Oncology Trials

Radiopharmaceutical therapy is emerging as a safe and effective targeted approach to treating many types of cancer. Clinical trials for these therapies are complex requiring a multi-disciplinary approach and careful coordination to produce meaningful and conclusive results. In this webinar, we look at the history and future trajectory of radiopharmaceuticals, describe their potential advantages, examine...

Regulatory Considerations for Radiotherapeutics and Radiodiagnostics

Scientific innovation and advances in ligand targeting have spurred the development of many different types of radiopharmaceuticals (RPs) – radioisotopes bound to biological molecules to target specific organs, tissues, or cells within the body — with a wide range of clinical uses. As those uses have proliferated, and as research has continued to yield novel...

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,...

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...

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,...

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...