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

13-Jun-2017 - Last updated on 14-Jun-2017 at 15:04 GMT

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

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.”