Clinical Research: Phase 1 - Phase 4

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...

Clinical Research: Phase 1 - Phase 4

Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines

Introduction Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of response rate showed only 10 percent of these therapies demonstrate an overall...

Clinical Research: Phase 1 - Phase 4

Opportunities Beyond Hope: Immuno-Oncology Drug Development

Introduction Over the past decade, immune-oncology (IO) has become one of the most promising and fastest-growing areas of cancer research and drug development. Present-day advances in immuno-oncology can be attributed to an explosion of research in this area in recent years, leading to a paradigm shift in the understanding of cancer. Until the late 1990s...

Clinical Research: Phase 1 - Phase 4

Antibody-Drug Conjugates in Oncology: Key Considerations and Future Trends

Antibody-drug conjugates (ADCs) are an active area of oncology research, partly due to advances in synthetic biochemistry that may help improve the tissue specificity and cytotoxicity of these complex therapeutics. In recent years, the pace of development for this class of cancer therapeutics has been increasing, with 12 ADCs  approved by the FDA since June...

Clinical Research: Phase 1 - Phase 4

Premier Insight 282 | Leveraging the Power of Communication: Supporting Enrollment of a Phase 2 Cervical Cancer Study During a Pandemic

Background Cervical cancer is the fourth most common cancer in women. Despite being highly preventable, over 600,000 women were diagnosed and more than 340,000 died from the disease worldwide in 2020. The majority of cervical cancers are caused by infection with human papillomavirus (HPV) and the implementation of HPV vaccines has been shown to reduce...

Clinical Research: Phase 1 - Phase 4

Leveraging Real-World Data & Real-World Evidence to Support Regulatory Decision Making

The FDA is committed to increasing sponsor opportunities to apply RWD and RWE to support regulatory decision-making.1 The goal is to use quantities of available data, streamline the drug development process, and learn how interventions perform in real-world use, outside the strictly controlled limits of a clinical trial. According to legal and scientific standards, the...

Clinical Research: Phase 1 - Phase 4

Pharmaceutical Outsourcing | Registries and Natural History Studies in Rare Disease Drug Development

Increasing emphasis on rare diseases has led to a greater need to accurately define the profile, characteristics, and outcomes of patients living with those conditions. The development of safe and effective treatments of rare diseases requires a deep understanding of the disease of interest, including its frequency, clinical features, risk factors, outcomes, burden, and evolution....

Clinical Research: Phase 1 - Phase 4

A Fit-for-Purpose Path Forward: Linking RWD to Your Overall Data Strategy

Real-world data (RWD) and real-world evidence (RWE) have become an increasingly important part of the medical product development landscape. These tools can enable sponsors to optimize clinical trial designs and demonstrate the real-world effectiveness of new medical products. Part 2 of this three-part blog series outlines a fit-for-purpose approach to RWE. (See Part 1:  What...

Clinical Research: Phase 1 - Phase 4

What is Real-World Data and Evidence and How It Can Facilitate Clinical Development

The 21st Century Cures Act (Cures Act)1 signed into United States law in 2016 aims to accelerate medical product development and bring innovations to patients faster through real-world evidence (RWE) to support regulatory decision making. Incorporating real-world data (RWD) and real-world evidence (RWE) can help pharma and biotech companies optimize clinical trial designs and demonstrate...

Clinical Research: Phase 1 - Phase 4

The Expanding Role of RWE in Rare Studies

September 29th, 20222:00 p.m. AET / 1:00 p.m. KST / 12:00 p.m. SGT Real-world evidence is increasingly important in drug development as the medical and pharma communities recognize the data’s potential for predicting the benefits of treatment interventions. Accelerating this trend is the Food and Drug Administration’s growing understanding of how RWE has helped researchers...