Tag: webinar

Clinical Research: Phase 1 - Phase 4

5 Key Takeaways: Insights on Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies

Traditionally, Phase 1 trials commonly utilize 3+3 designs to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Studies have shown, however, that two out of three trials employing a 3+3 design failed in identifying the MTD, and better approaches are needed.1 During Premier Research’s recent webinar Alternative Designs to the...

Clinical Research: Phase 1 - Phase 4

Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies, Upcoming Webinar

TORONTO (PRWEB) FEBRUARY 08, 2021 Phase 1 clinical trials aim to determine the maximum tolerated dose (MTD) of a new molecule with the goal of identifying a recommended Phase 2 dose (RP2D), often the MTD itself. Ideally, the RP2D would have adequate therapeutic effect to demonstrate preliminary signs of efficacy in Phase 2, but many...

Clinical Research: Phase 1 - Phase 4

Drug and Device Development Secrets in the World of Medical Aesthetics, Upcoming Webinar

TORONTO (PRWEB) NOVEMBER 09, 2020 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,...

Clinical Research: Phase 1 - Phase 4

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

TORONTO (PRWEB) NOVEMBER 02, 2020 Setting up an effective phase 1 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 interrelated to ensure a timely dose determination that is nimble and allows flexibility. What factors can affect, or...

Clinical Research: Phase 1 - Phase 4

mHealth and Remote Clinical Trial Strategies to Include in Your Next Study, Upcoming Webinar

TORONTO, ONTARIO (PRWEB) OCTOBER 01, 2020 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...

Clinical Research: Phase 1 - Phase 4

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

TORONTO (PRWEB) SEPTEMBER 15, 2020 Though gene therapy has been around for decades, it continues to pose extraordinary challenges in the areas of R&D, clinical development, and operation of clinical trials. Sponsors and CROs face shifting operational and regulatory demands amid rapid advances in the science of precision medicine. This webinar will examine the evolving...

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?...