Clinical Research: Phase 1 - Phase 4

Data at Your Fingertips: The Case for Centralized Monitoring

In the dynamic arena of clinical trials, optimizing efficiency, maintaining cost-effectiveness, and safeguarding the integrity of collected data are important considerations. Traditional onsite monitoring has long been the cornerstone of ensuring data accuracy and patient safety. However, as technology and data analytics advance, a more efficient and effective approach has emerged—centralized monitoring. In this blog,...

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...

8 Cost Containment Strategies for Rare Disease Clinical Trials

In a world of ever-increasing clinical trial costs, sponsors can feel overwhelming pressure to stretch their budgets without sacrificing the data they need for regulatory approval. In rare diseases, this pressure is intensified with the many challenges that often accompany these trials, such as small patient populations, limited disease data, and patient engagement challenges. Here...

5 Stepping Stones to the Future State of Rare Disease Clinical Development

Rare diseases are a distinctive and complex field within clinical development, characterized by significant hurdles from start to finish. Addressing these complexities requires innovative approaches to achieve a future of adaptability, quality, and efficiency. Here are 5 key steps to bringing rare disease clinical development forward. Predicting the Future of Rare Disease Research As we...

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...

Navigating the FDA’s Draft Guidance on Psychedelic Drug Development

The FDA’s Center for Drug Evaluation and Research issued a structured, meticulous roadmap to advance the clinical development of psychedelic drugs, highlighting key considerations in regulatory frameworks, ethical conduct, chemistry manufacturing controls (CMC), and clinical studies to ensure safety and efficacy in addressing psychiatric and substance use disorders. In this blog, Premier Research dissects the...

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...

Leveraging Technology and Expert Clinician Review to Enhance Risk Detection in Neuroscience Studies

Across all indications, the primary source of trial failure has been—and remains—an inability to demonstrate efficacy.1 An analysis of 640 phase 3 trials with novel therapeutics demonstrated that 54% failed in clinical development. Among those that failed, more than half—57%—failed due to inadequate efficacy.2 In neuroscience indications, an estimated 85% of late phase studies fail,...

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...

What Patient Population is Participating in Your Early-Phase Gene Therapy Trials? These Factors Could Influence Your Strategy

Today there are over 10,000 rare diseases affecting more than 30 million people in the U.S.1 Many of these disorders are life-threatening, and more than 90% do not have a U.S. FDA-approved treatment2. Novel gene therapies offer hope for improving the health of patients afflicted with these conditions. Securing clearance for these treatments is...