Lower participation, slower studies delaying Alzheimer's research, says IRB

By Melissa Fassbender contact

- Last updated on GMT

Schulman IRB has partnered with the National Biomedical Research Ethics Council. (Image: iStock/kunertus)
Schulman IRB has partnered with the National Biomedical Research Ethics Council. (Image: iStock/kunertus)

Related tags: Neurology, Clinical trial, Alzheimer's disease, Alzheimer

At least 50,000 volunteers are needed to participate in clinical trials for Alzheimer’s disease – the global cost of which is expected to reach $2 trillion by 2030.

According to a report published​ in the Journal of the Alzheimer’s Association, the worldwide costs of dementia were estimated at $818bn in 2015 and are projected to cost $2 trillion a year globally by 2030.

To address the myriad challenges facing Alzheimer’s disease research, the National Biomedical Research Ethics Council (NBREC) and Schulman IRB have teamed up to improve research protocols and expedient study completion.

The announcement also follows the US National Alzheimer's Project Act​ and a recent NIH mandate for single IRB review​ in multisite clinical trials.

The alliance marries NBREC’s network of dementia researchers with Schulman’s expertise and experience conducting single IRB review for multi-site research​,” Schulman’s COO Eli Alford told Outsourcing-Pharma.com.

The alliance aims to improve the quality and efficiency of Alzheimer’s disease research and subsequently, other neurological disorders affecting memory, mood, and movement, Alford explained.

"We bring together industry leaders and distinguished scientists, applying their expertise first to scientific review of protocol feasibility and then to regulatory and ethical review within the IRB process," ​he said.  

Ultimately, our objective is to make research protocols better, reducing the likelihood of amendments that result in costly changes in a study’s lifecycle, and speeding study completion.​”

The launch of the new Central Neurology Review service, which is set for July, follows the successful implementation of Schulman’s Central Oncology Review service six months ago. 

Alford said the company expects additional therapeutically-focused service offerings to follow.

Improving the odds

When asked what some of the main challenges are facing Alzheimer’s research, Alford said it would be easy to point to recent headline-grabbing failures of experimental drugs in the Alzheimer’s research space. However, “disappointing as those failures are, actually the primary challenge is finding enough volunteers willing to participate in studies overall​,” he explained.

Currently, there are more than 400 studies​ recruiting on ClinicalTrials.gov – and at least 50,000 volunteers are needed, according to the Alzheimer’s Association​.

Lower participation rates mean slower studies, delayed results and ultimately delayed advancements in prevention, diagnosis, and treatment​. That’s the challenge​,” said Alfrod.

It’s time for fresh approaches that improve the odds of success for research that will pave the way to prevent, diagnose, and treat this disease​.”

Related news

Show more

Related products

show more

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Baxter BioPharma Solutions | 05-Nov-2018 | Technical / White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

Baxter’s Oncology Contract Manufacturing

Baxter’s Oncology Contract Manufacturing

Baxter BioPharma Solutions | 29-Aug-2018 | Product Brochure

Baxter BioPharma Solutions’ FOYA award-winning facility in Halle/Westfalen, Germany, offers state-of-the-art parenteral cGMP manufacturing at one location,...

Related suppliers

Follow us

Products

View more

Webinars