Tag: oncology

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

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...

Clinical Research: Phase 1 - Phase 4

Making the Asia-Pacific Region a Destination of Choice for Oncology Clinical Trials

Introduction Over the past decade, the Asia-Pacific (APAC) region has seen the most robust growth in oncology clinical trial activity, with a 138 percent increase over the period from 2010 to 2020. In fact, APAC now ranks first in the world for total number of ongoing oncology clinical trials, with China accounting for more than...

Clinical Research: Phase 1 - Phase 4

The Expanding Role of RWE in Rare Studies

August 4th, 202210:00am EST 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 better understand and use COVID-19 treatments. While placebo-controlled trials...

Clinical Research: Phase 1 - Phase 4

Addressing Challenges in Bringing Male Contraceptives to Market

There are currently more than a dozen categories of female birth control with proven efficacy on the market. Conversely, the only options available for men today are condoms and vasectomy, despite decades of research. No new male contraceptive products have entered the market since the condom was created in the 1800s. This is in part...

Clinical Research: Phase 1 - Phase 4

Addressing the Challenges and Opportunities in Gynecologic Cancer Research

Gynecologic cancers continue to be a significant cause of female morbidities and mortality worldwide. Significant unmet needs exist in diagnosis and treatment. These cancers are often detected at later stages when therapeutic options are limited, and advanced or recurrent disease leads to a poor prognosis. Earlier diagnosis and more effective treatments will enhance the quality...