Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

Choose the Right FDA Program to Expedite Your Rare Oncology Trial

Rare cancers account for 27 percent of all new cancer diagnoses in the U.S. and 22 percent of all new cancer diagnoses in the EU  With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Faced with limited...

Clinical Research: Phase 1 - Phase 4

Drug and Device Development Secrets in the World of Medical Aesthetics

New treatment options for aesthetic indications are in record-high demand, fueled by an aging population, and a growing focus on aesthetic issues related to nutritional habits, sedentary lifestyles, the complex stresses of 21st-century life and rising awareness about aesthetic solutions in all adult age groups. The search for more effective, less invasive, more affordable and safer solutions...

Clinical Research: Phase 1 - Phase 4

Adaptive Design Methods Offer Rapid, Seamless Transition Between Studies

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers , each with a unique implication for patient management and therapy....

Clinical Research: Phase 1 - Phase 4

The Importance of Site Selection and Dosing Strategies in Early-Phase Oncology Studies

Setting up an effective phase one trial for a novel investigational oncology product is rife with challenges. Every aspect from site identification to estimation and coordination of enrollment and safety review is interconnected. Nuance is important. What factors can affect, or even derail, the timeline? Who are the key influencers and experienced sites? Does a...

Clinical Research: Phase 1 - Phase 4

Tumor-Agnostic Treatments: A Game Changer for Rare Oncology Trials

Rare cancers account for almost a quarter of all new cancers worldwide though there is no universally adopted definition for rare cancers. In the U.S., rare cancers are defined as those with fewer than 15 cases per 100,000 per year, whereas in the EU, they are defined as six cases per 100,000 per year. Historically,...

Clinical Research: Phase 1 - Phase 4

mHealth and Remote Clinical Trial Strategies to Include in Your next Study

What happens when patients and clinical research associates alike can’t—or won’t—go to your clinical trial sites? It’s time for a new plan. In the months since the novel coronavirus brought all normal activity to a halt, clinical trials worldwide have been forced to re-examine their strategies and reconsider their approach to data collection, data monitoring,...

Clinical Research: Phase 1 - Phase 4

Essential Strategies in Dermatology Clinical Trials: The Convergence of Patients, Regulations, and Study Design

Competition for patients among sponsors in the field of dermatology drug development has never been as intense as it is now — so much so that it’s becoming difficult to meet project timelines, attract and retain patients, and achieve comprehensive study results. Patients are in high demand, and making studies appealing to them — convenient,...

Clinical Research: Phase 1 - Phase 4

Operational & Regulatory Factors in Cross-Border Enrollment in Rare Disorders

Researchers are more focused than ever on finding treatments and cures for rare diseases, encouraged by a regulatory environment that is increasingly welcoming to innovation and collaboration. But even under these favorable conditions, the potential success of orphan drug development hinges on finding patients and getting them to trial sites. Patients for rare disease trials...

Clinical Research: Phase 1 - Phase 4

Achieving the Promise of Gene Therapy: New Pathways to Overcome Patient Enrollment and Safety Challenges

Meeting shifting operational and regulatory demands in precision medicine trials This webinar examines the evolving science of gene therapy, covering current approaches such as gene transfer and gene silencing, safety considerations, and delayed adverse events. Learn about the current regulatory landscape, identify opportunities to more closely engage with regulators, and more. Topics in this presentation...

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...