Study Design

Clinical Research: Phase 1 - Phase 4

A New Era in Dermatology: Study Design, Regulatory Strategies, and Patient Participation

Explore dermatology trials from the vantage point of study design, patient access, data quality, regulatory considerations, and more This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical...

Resources for Childhood Cancer Awareness Month

Premier Research is dedicated to helping patients and families around the world overcome the burden of debilitating diseases, such as a cancer diagnosis. Cancer is a leading cause of death for children and adolescents, and there are approximately 300,000 children diagnosed with cancer each year around the world.1 With the help of better therapies, more...

Premier Presentations from WODC

Watch Premier Research’s presentations from World Orphan Drug Congress 2020 below. Note: You must be logged into your WODC Swapcard account to view presentations Rare Disease Recruitment: Addressing Enrollment Hurdles and Differentiating Your Clinical Trial in an Increasingly Competitive Research Environment Jonathan Kornstein, Executive Director, Program Strategy, Rare Disease & Pediatrics, shares tips for overcoming...

Regulatory Challenges in Global CAR-T Cell Therapy Development

When exploring the complex and rigorous regulatory landscape for CAR-T cell therapies, sponsors may encounter challenges in their efforts to bring products to market Since the historic approval of Kymriah® (tisagenlecleucel) in 2017, research on chimeric antigen receptor (CAR) T cell therapy has accelerated. There are more than 230 regenerative medicine companies in Europe and...

Expert Reaction to a Study Looking at Caffeine and Pregnancy

A study, published in BMJ Evidence Based Medicine, looked at caffeine use and pregnancy. At Science Media Center, Dr. Adam Jacobs, Associate Director of Biostatistics, Premier Research, said: “I note the author has published 2 books on the dangers of coffee which in my opinion should have been included in declarations of interest for the journal article....

Considerations for Applying Adaptive Design Approaches to Early Oncology Studies

By utilizing accumulating data to modify the operating characteristics of an active trial in accordance with pre-specified rules, adaptive designs can make clinical trials more flexible, efficient, and informative than fixed-sample designs.[1] Adaptive design approaches can be applied across all phases of clinical development, including early oncology studies. These designs introduce real-time flexibility while a...

Minimizing Early-Stage Oncology Failures with Adaptive Design Approaches

Despite advances in our understanding of the complex genetic, molecular, and immunological factors which lead to cancer, the success and likelihood of approval rates for oncology remain low. According to a recent study performed by the Biotechnology Innovation Organization (BIO), nearly one-third of drugs entering phase 2 studies between 2006 and 2015 failed to progress....

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...

PREMIER VOICES #13: Early-Phase Oncology – Emerging From the Crisis & Innovating for the Future

Featured Guests Luke Gill, B.Sc., M.Sc., MBAVice President, Oncology Luke Gill is the head of Oncology Clinical Development Services at Premier Research. He works collaboratively with biotech sponsors, the scientific community, and other stakeholders to develop and implement strategic approaches to early phase oncology development and CAGT trials. As a drug development expert, Gill has...

Long-Term Follow-Up in Gene Therapy Trials: Ensuring Patient Engagement & Regulatory Compliance

Gene therapy products are typically designed to achieve therapeutic effect through long-acting or permanent changes in the human body. Due to this extended period of exposure, patients who receive gene therapies may be at increased risk of delayed adverse events. To understand and mitigate the risk of these delayed adverse events, participants in gene therapy...