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


Lyophilization Scale-Up and Tech Transfer

Baxter BioPharma Solutions | 12-Mar-2018 | Technical / White Paper

There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation...

How will Brexit affect the Pharmaceutical Industry?

How will Brexit affect the Pharmaceutical Industry?

Source BioScience Ltd | 08-Mar-2018 | Technical / White Paper

Have you prepared your strategy for the outcome of Brexit to ensure that you can continue to supply the UK market?
Source BioScience is a CRO with...

Leveraging Best Practices in Primary Packaging

Leveraging Best Practices in Primary Packaging

Catalent Pharma Solutions | 05-Mar-2018 | Technical / White Paper

When planning a clinical trial, overlooking the importance of primary packaging can be a mistake. From stability concerns to labeling to patient compliance...

VDS groß

Meet the challenges of complex injectables

Vetter Pharma International GmbH | 07-Nov-2017 | Technical / White Paper

In the time it takes from the exciting discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can...

Related suppliers