Tag: Neuroscience

Consulting

The 3 Ds of a Successful Strategic Sponsor-CRO Partnership

Want to know how to build strong strategic sponsor-CRO partnerships? Commit to the three Ds: Start with a dialogue that establishes the project’s direction, ultimately making a difference in the relationship. In these relationships, a CRO must bring to the table the supplemental expertise a sponsor doesn’t know they don’t have, but needs for success. 1. Foster a Dialogue Bidirectional communication is probably the...

Study Design

AD Trials: Is your protocol asking the right questions?

Most trials for potential Alzheimer disease (AD) treatments fail—and the reason may be poor protocol design. After all, typical AD studies are double-blind placebo-controlled parallel group clinical trials with a dual outcome, including a cognitive measure and a global impression of aptitude for the activities of daily living—a trial design originally developed to study cholinesterase...

Clinical Research: Phase 1 - Phase 4

Global Alzheimer’s Disease Trials: 10 Factors to Consider

Roughly 47 million people around the world are living with Alzheimer’s disease (AD) — a number that is expected to increase to 75 million by 2030 and 150 million by 2050. Researchers are pursuing a range of treatments: disease modifying, symptomatic treatment and therapy for behavioral issues. Yet no new therapy has been approved since...

Clinical Research: Phase 1 - Phase 4

A Vast Unmet Need: Challenges In Alzheimer’s Clinical Trials

Dementia is a growing global epidemic, affecting nearly 47 million people worldwide. That number is expected to approach 75 million by 2030, when the cost of patient care is forecast to reach $2 trillion. And the trend will only accelerate: By 2050, it’s estimated that 115 million will suffer from some form of dementia. Alzheimer’s...

Patient and Stakeholder Engagement

7 Ways to Engage Military Vets in PTSD Clinical Trials

Combat related trauma is significantly affecting U.S. military veterans compared to other military populations across the globe. As many as 20 percent of the U.S. military veterans who served in Iraq and Afghanistan and up to 30 percent of those who fought in the Vietnam War will suffer from Post-Traumatic Stress Disorder (PTSD) in a...

Patient and Stakeholder Engagement

3 of the Hardest Obstacles We Face in Alzheimer’s Clinical Drug Trials

For the estimated 30 million people worldwide who have Alzheimer’s disease, progress toward understanding and treating this most prevalent form of dementia is frustratingly slow. The few approved drugs address only the condition’s symptoms, though scores of drugs to prevent onset or alter the disease’s course are now under study. From high screen failure rates...

Clinical Research: Phase 1 - Phase 4

Fragile X: The Quest to Treat a Complex, Little-Understood Condition

We worked on a Phase II study of a drug to treat Fragile X syndrome that, like most rare work we do, was a challenge from the start. Fragile X is a rare and not fully understood genetic disorder, typically resulting from an expansion of the CGG triplet repeat within the Fragile X mental retardation 1 (FMR1) gene...

Consulting

Forging Strong Sponsor-CRO Relationships: Join Us at OCT New England

DURHAM, N.C., SEPTEMBER 5, 2017 — Sponsors and CROs can forge stronger relationships by pursuing long-term partnerships that value collaboration over transactions. Premier Research’s top neuroscientist will discuss how when she hosts a session at Outsourcing Clinical Trials New England in Boston. Krista Armstrong, Vice President and Head of Neuroscience, will describe best practices for...

Clinical Research: Phase 1 - Phase 4

The Placebo Problem, Part 3: Psychological Underpinnings

This is the third installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Additional posts in the series can be accessed here. Solutions to the placebo problem require an understanding of the underlying mechanisms. Broadly, research on contributors to the placebo response falls into two...

Clinical Research: Phase 1 - Phase 4

The Placebo Problem, Part 2: Rising Response

This is Part Two of our series on the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the other parts here. Analgesic and psychiatric drug development is facing an enormous problem: rising placebo responses in randomized controlled trials (RCTs) threaten the ability of pharmaceutical companies to successfully identify novel...