Tag: Neuroscience

Consulting

Strengthening Neuroscience Clinical Research Through Innovation

There’s a lot of discussions these days about innovative ideas to make clinical research more patient-focused. The concept goes hand-in-hand with the development of technology that permits researchers to design and execute trials that can significantly reduce the burden of participation. Development of neuroscience drugs is benefiting from these advances in patient-focused research, as new...

Consulting

Parkinson’s: Why Has Disease Modification Failed — and What Now?

Researchers have made many attempts at disease modification as they pursue breakthroughs in treating Parkinson’s disease, but so far without success. Why have these efforts failed, and what’s next in treating this degenerative disorder that affects an estimated 10 million people worldwide? We tackled these questions in a Premier Research webcast, The Potential for Disease...

Clinical Research: Phase 1 - Phase 4

Finding the Path to Disease Modification in Parkinson’s Disease

Among common degenerative disorders, Parkinson’s disease strikes more frequently than all but one: Alzheimer’s. Parkinson’s affects about 1 percent of the population over age 60 and claims 60,000 new diagnoses in the United States each year.[1] The cause of Parkinson’s remains a mystery, and the dopamine promoter levodopa — notwithstanding its limitations — has been...

New Research Highlights the Challenges of Studying Alzheimer’s Disease

Recently, researchers at King’s College London published a study in Translational Psychiatry on a feedback loop underlying brain degeneration in Alzheimer’s disease (AD) that, they suggest, may be the reason so many clinical trials targeting this disease have failed. In this new study, the researchers found that when amyloid beta (Abeta) destroys a synapse, the...

Clinical Research: Phase 1 - Phase 4

Making the Case for Long-acting Antipsychotic Treatment

Medical science is making significant advances in treating schizophrenia, but for all the progress we’ve seen, patients don’t benefit much unless they regularly take their medications. Second-generation (or atypical) long-acting injectable antipsychotic treatments (LATs) that ensure consistent administration of medication have become widely available over the past 15 years, but they remain a tough sell...

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

Operational Challenges of Neuroscience Clinical Trials, Part 3: Patient Recruitment

Last week, we discussed the high placebo response that plagues neuroscience clinical trials. Today we turn to another common challenge: patient recruitment. We’ll take a look at three strategies that can be used to improve trial participation: the use of several patient sources when recruiting a focus on patient-centric solutions the use of patient recruitment...

Clinical Research: Phase 1 - Phase 4

Operational Challenges of Neuroscience Clinical Trials, Part 2: High Placebo Responses   

Neuroscience clinical trials, especially those for psychiatry and analgesia indications, have always had to deal with the challenge of high placebo response. Most troubling is that the placebo response rate seems to be on the rise, at least in the U.S.   Bigger placebo responses make it harder to show that an experimental treatment is...

Clinical Research: Phase 1 - Phase 4

Operational Challenges of Neuroscience Clinical Trials, Part 1: Overview

With billions of neurons, the brain is the most complex organ in the body, so it’s not surprising that neuroscience clinical trials—more so than trials in other medical specialties—face major challenges, both conceptual and practical. In this new blog series, we’ll look at the challenges sponsors face when operationalizing clinical trials and share lessons from...

Medical and Regulatory Affairs

The Ongoing Quest for Evidence on the Health Effects of Cannabis and Cannabis-Derived Products

Inadequate funding and burdensome regulatory barriers in the United States are two challenges that must be tackled if clinical researchers are to answer important public health questions about the pros and cons of cannabis and cannabinoid use, one of the world’s leading scientific bodies has concluded. These are among nearly 100 conclusions and recommendations reached...