Study Design

Medical and Regulatory Affairs

Medical Design & Outsourcing – What you need to know about growing cyber threats to medtech

Medical Design & Outsourcing – What you need to know about growing cyber threats to medtechby Nach Davé, Vice President, Global Regulatory Affairs & John Pappan, Director, Medical Device Regulatory

Study Design

Neuropathic Pain: What It Is, How It’s Diagnosed, How It’s Treated

Between 7 and 10 percent of the U.S. population suffers from some type of neuropathic pain, and a significant share of those affected require chronic pain treatment.[1] This high rate of occurrence makes our limited understanding of these afflictions, and the long search for effective treatments, all the more frustrating. Treating neuropathic pain starts with...

Clinical Research: Phase 1 - Phase 4

The Potential For Disease-Modifying Therapies In Parkinson’s Disease

Parkinson’s disease is a progressive neurodegenerative disease that strikes its victims in the prime of their lives. Most available treatments have remained largely unchanged for years, with Levodopa the “gold standard” for treating Parkinson’s disease for nearly 50 years, with only marginal advances in improving the drug’s efficacy. It also only targets the symptoms, not...

Clinical Research: Phase 1 - Phase 4

Neuropathic Pain Studies: Patient Selection, Study Design, And Clinical Trial Challenges

Treatment of neuropathic pain has been a challenge for drug developers for years. Opioids show limited efficacy and are subject to abuse. Tricyclic antidepressants, long considered first-line therapy, have been hampered by side effects and are still effective in only about one-third of patients. Treatment of neuropathic pain has been a challenge for drug developers...

Medical and Regulatory Affairs

5 Reasons to Consider APAC for Clinical Trials

Small and mid-size biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies. In fact, the number of clinical trials in...

Clinical Research: Phase 1 - Phase 4

Applied Clinical Trials – Alzheimer’s Clinical Trials: Obstacles and Opportunities

Applied Clinical Trials – Alzheimer’s Clinical Trials: Obstacles and Opportunitiesby Krista Armstrong, Ph.D., Vice President & Head of Neuroscience & Sebastian Turek, Project Director, Neurology

Clinical Research: Phase 1 - Phase 4

Finding the Fast Track in Early-Phase Oncology Trials

Put yourself in this scenario: Your compound is a newly validated mutated receptor that is present in only a limited number of cancer patients, and there is no approved diagnostic test. Your product, an antibody-like molecule that inhibits the receptor’s activity, also stimulates a potent immune response. Further complicating things, much of the preclinical data...

Consulting

Driving Product Development and Finding the Fast Track in Early-Phase Oncology Programs

Small- to mid-sized biotech and pharma companies face many challenges when planning and executing an early-phase oncology trial, from performing a regulatory gap analysis and developing a target product profile to identifying the right patients and selecting efficacy endpoints.

Clinical Research: Phase 1 - Phase 4

Key Considerations When Designing a Phase I Oncology Trial

Traditionally, phase I oncology trials have relied on a standard 3+3 dose escalation design to achieve the objective of defining a recommended phase II dose (RP2D). However, statistical simulations have shown that as few as one in three trials using the 3+3 design succeed in identifying the maximum tolerated dose.[1] Concerns have also been raised...

Study Design

Considerations for the Design and Execution of Medical Device Trials

While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed. Here are a few of the key differences: Requirement for a clinical trial When studying...