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

Pursuing Parkinson’s Disease Gene Therapies: Strategies & Operational Requirements

Clinical Research: Phase 1 - Phase 4

Pathways to Expedited Drug Development in the U.S. and Europe

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

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...

Patient and Stakeholder Engagement

The Art and Science of Selecting Patients for Phase 1 Oncology Studies

The primary purpose of early-stage clinical trials is to determine the recommended dose and toxicity profile of an investigational drug or multi-drug combination therapy. Since molecularly targeted agents (MTAs) and immunotherapies have toxicities that are distinct from cytotoxic chemotherapies, traditional dose escalation methods using toxicity-based endpoints may not be suitable for phase I studies of...

Consulting

Planning a Gene Therapy Trial? Ask an Expert — and Pay Attention

It’s been 46 years since researchers Theodore Friedmann and Richard Roblin published a landmark paper in the journal Science that posed a provocative question: “Gene therapy for human genetic disease?” And while clinical trials for gene therapy drugs have become much more common in the past 20 years — more than 2,400 had been conducted...

Clinical Research: Phase 1 - Phase 4

Gene Therapy 101: From the 1960s to Today

Gene therapy is a hot topic in clinical research today — and for good reason! These technologies have the potential to treat — and in some cases even cure — a wide range of conditions, including rare genetic disorders that previously had no effective therapies. What Is Gene Therapy? Gene therapies are a diverse group of...

Consulting

Webinar Explores Expanding Role of Immuno-Oncology Drugs

DURHAM, N.C., MAY 23, 2017 — Interleukin-2, interferon, and other immune-modulating agents have long been used to treat some solid malignancies, but their efficacy is generally limited to immunogenic cancers such as melanoma and kidney cancer. Until now. Today, multiple immuno-oncology pathways are under development, and we’ll explore this promising trend in a webinar on...

Quality

The Trends Reshaping Medical Device Trials: Attend Our Webinar on Nov. 2

DURHAM, N.C., OCTOBER 27, 2016 — Medical device and diagnostic companies are conducting more clinical trials than ever, a trend that’s giving rise to new procedures and best practices for studies that differ in many ways from pharmaceutical trials. Register for this webinar focused on the evolution of device clinical research on Wednesday, November 2....