Welcome to part two of our blog series focused on the integration of diversity, equity, and inclusion (DEI) into clinical research. If you missed part one of the series that highlights recent FDA initiatives and legislative changes behind these developments, click here. In today’s clinical research environment, sponsors face the challenge of comprehensively incorporating DEI...
Introduction When approached for an early-in-illness schizophrenia trial, Premier Research knew that patient recruitment would be challenging and require creative approaches for success. Based on our experience in mental illness studies and with this indication, we recognized the importance of identifying sites where patients were already being diagnosed and treated. To achieve this, the Premier...
In the ever-evolving field of global clinical research, the integration of diversity, equity, and inclusion (DEI) has become a pivotal focus, especially considering recent FDA initiatives and legislative changes. The U.S. Food and Drug Administration’s (FDA) ongoing efforts, coupled with the enforcement of the DEPICT Act and impending final regulatory guidance, highlight the urgency and...
Centralized monitoring’s state-of-the-art approaches and tools are reshaping clinical trials’ efficiency, accuracy, and overall effectiveness. Here we discuss the core methodologies that underpin centralized monitoring—study-level and patient-level data analysis—and how these strategies collaboratively refine the monitoring process. Moreover, we outline seven compelling reasons why shifting from traditional monitoring to a sophisticated, centralized approach is not...
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,...
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...
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...
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...
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...
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...