Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

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

TORONTO (PRWEB)AUGUST 28, 2020 New treatment options for moderate to severe dermatological diseases and areas of high unmet need are driving a revolution in clinical development of dermatology drugs. But questions remain: What indications should be pursued? How to design a study that targets the right endpoints? And how will environmental constraints affect the research?...

Clinical Research: Phase 1 - Phase 4

Setting a Real-World Strategy in an Evolving Clinical Research Environment

Presented byStacy Weil, Senior Vice President, Clinical Data Operations, Strategic Business Optimization & Nach Dave, RPh., MSc, Vice President, Development Strategy Related Resources Real-World Data and Real-World Evidence: What Is Their Value as a Synthetic Control Arm? Data Driven: How Electronic Patient-Reported Outcomes (ePROs) Provide a Vital Opportunity to Capture Key Data Beyond the COVID-19...

Clinical Research: Phase 1 - Phase 4

Setting a Real-World Strategy in an Evolving Clinical Research Environment

Presented byStacy Weil, Senior Vice President, Clinical Data Operations, Strategic Business Optimization, & Nach Dave, RPh. MSc, Vice President, Development Strategy Since early this year, many standard clinical trial processes have been significantly disrupted. Patients have been prevented from attending regular physician visits. Clinical research associates who traveled regularly to study sites to review and...

Clinical Research: Phase 1 - Phase 4

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...

Clinical Research: Phase 1 - Phase 4

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. Of...

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

Novel Trial Approaches for Rare Cancer Patients, Upcoming Webinar

TORONTO (PRWEB) AUGUST 4, 2020 Join Rupa Doshi, Ph.D., Executive Director –Program Strategy, Oncology, Premier Research and Sameena Sharif, Ph.D., Senior Vice President, Product Strategy, Premier Research in a live webinar on Monday, August 24, 2020 at 11am EDT (4pm BST/UK). Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no...

Clinical Research: Phase 1 - Phase 4

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...

Clinical Research: Phase 1 - Phase 4

Oncology Trials in the Time of COVID-19: Expert Insights

Best practices for managing ongoing cell and gene therapy trials Personalized medicine is radically changing how the world looks at cancer therapy. Having completed more than 170 hematology and oncology trials, we know what it takes to optimize studies for these next-generation biotherapies with expertise ranging from small dose-finding studies to large multinational trials. In...

Clinical Research: Phase 1 - Phase 4

Addressing a Critical Unmet Need: Considerations for Designing and Conducting Neonatal Clinical Trials

Introduction Due to the challenges associated with studying investigational medical products in neonates, healthcare professionals must often resort to administering drugs in neonatal intensive care units (NICUs) off-label. While numerous pediatric legislative initiatives have been passed worldwide, neonates are still largely treated with medicines that have not been specifically studied or approved in this young,...