White Papers

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

Making the Switch from Rx to OTC

Introduction With the support of patients, regulators, and payers, pharma and biotech companies’ interest in converting prescription drugs (Rx) to over-the-counter (OTC) is growing. In 2021, the sales value of Rx-to-OTC switches was around $35 billion USD. According to Future Market Insights, it is expected to rise at 5.3 percent compound annual growth rate (CAGR),...

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

Natural History Studies: Understanding and Enhancing Their Value in Rare Diseases

Successful drug development requires a comprehensive understanding of the underlying disease. To design reliable clinical trials with meaningful, measurable outcome measures, sponsors must apply thorough knowledge of disease presentation, manifestations, and progression, which may be challenging in rare diseases where this information is minimal. Thus, observational studies, encompassing both registry and natural history studies, play...

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...

Clinical Research: Phase 1 - Phase 4

Improving Birth Control for All: Opportunities and Obstacles in Male Contraception

Introduction There are currently more than a dozen categories of female birth control with proven efficacy on the market. For men, the only options available today are condoms and vasectomy. Despite decades of research and discussion about male contraception, no new products have entered the market since the condom was created in the 1800s. As...

Clinical Research: Phase 1 - Phase 4

Ten Tips for Establishing the Clinical Utility of Molecular Diagnostics: Stepping Stones to Precision Medicine

Introduction The strongest foundation for successful widespread marketing of any diagnostic is evidence of clinical utility. Clinical validation – determining a test’s ability to diagnose a health condition or predict risk of clinical outcomes – may fail to convince physicians and especially healthcare payers to accept a new diagnostic. Failure to gain payer acceptance may...

Clinical Research: Phase 1 - Phase 4

Opportunities Beyond Hope: Immuno-Oncology Drug Development

Introduction Over the past decade, immuno-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

Women-Centric Approach to Clinical Trials

Introduction For decades, women were left out of clinical trials, despite the fact that they often process drugs differently than men due to their size, biology, and physiology. It wasn’t until 1993 that the NIH Revitalization Act mandated women and minorities be included in clinical trials funded by the federal government. This has resulted in...