Study Design

Clinical Research: Phase 1 - Phase 4

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...

Study Design

Digital Disruption in Dermatology: The Role of E-Health Technologies in Clinical Care and Research

In a fast-paced digital world, healthcare has had to adapt to better serve consumers who increasingly prefer or rely on web- or app-based services. Telehealth (or e-health) solutions are providing increased access to care, making it easier not only for patients to receive care, but also for healthcare professionals to deliver that care. For healthcare professionals...

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

Dementia is a global epidemic, affecting nearly 50 million people worldwide. By 2050, it’s estimated that 115 million people will suffer from some form of dementia. Alzheimer’s disease (AD) is the most common type of dementia occurring late in life. AD is also the only condition among the leading causes of death that cannot currently be...

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. Sponsors of first-in-human trials of novel oncology compounds face significant challenges. Beyond the typical circumstances of limited budget,...

Quality

Operational Challenges of Neuroscience Clinical Trials, Part 4: Assessment Subjectivity

In this blog series, we’ve been discussing some of the challenges of conducting clinical trials in neuroscience. In our final post of the series, we turn to another major one: ensuring that assessments are conducted with high quality whilst also minimizing subjectivity. Rating subjectivity can make signal detection substantially more difficult, if not impossible. This...

Clinical Research: Phase 1 - Phase 4

PM360 – Maximizing the Probability of Trial Success for CAR-T Cell Therapies

CAR-T cells are complex products, and translating them from basic and preclinical research to clinical trials and commercialization can be challenging. Understanding the regulations and developing a protocol that puts safety first—at every stage of development—are important first steps in bringing promising CAR-T cell therapies to the patients who need them most. CAR-T Cell Therapies:...