The Alzheimer’s Clinical Trial Consortium (ACTC), funded by the NIH, aims to accelerate and expand studies for therapies in Alzheimer’s disease and related dementias.
The consortium will be supported by an award of nearly $70m over the next five years, during which time it is expected to have the capacity to coordinate five to seven trials. Funding for the specific trials will be awarded through a separate grant process.
The full-service consortium will consist of up to 35 sites across the US, all of which will be required to use a centralized institutional review board (IRB) – an NIH mandate for all multi-site trials.
While some of the sites have already been chosen, commercial sites will also have the opportunity to join, explained Laurie Ryan, PhD, chief of the Dementias of Aging Branch in NIA’s Division of Neuroscience, which leads NIH research on Alzheimer’s.
The NIH works closely with industry, especially with smaller companies that require more support, Ryan told Outsourcing-Pharma.com.
“A lot of these large trials are actually public/private partnerships,” she added, noting that the NIH has a large translational program of which the ACTC is just one piece.
“We really do see this as a pipeline where we go from early discovery to hopefully moving things into the clinic,” she said. “We want to be leaders in creating novel design.”
Revamping the consortium model
The NIH has had a consortium for clinical trials dating back to 1991; as with other NIH and industry-sponsored trials in the past, staff were allocated to other projects between trials. However, one of the general criticisms of this model is that “you have to have people who are ready to go,” said Ryan.
As such, the NIH realized it needed to have a dedicated infrastructure even during downtime when trials aren’t being conducted, otherwise staff is lost, Ryan explained – a challenge not specific to the NIH, but one that plagues industry-sponsored trials as well.
“We realized that we needed to make some changes to enhance the consortium,” she said.
“The idea is to have a standing infrastructure with trained staff, dedicated staff, at not only the coordinating center but at each of the sites,” Ryan explained. “That’s really sort of the new model as well as a big focus on recruitment.”
Recruitment and trial delays
Recruitment has always been an issue, Ryan said – especially with such large-scale prevention studies.
For the NIH’s A4 (Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease) study, 7,000 participants were screened to enroll approximately 1,000 in the study, she explained to exemplify the challenge.
“There’s a huge demand and we need to actually have a system that also will hopefully make it a little more streamlined,” she added.
As Ryan explained, the new consortium will have centralized contracting, which should help streamline the process, “and get the trials started sooner, which means hopefully we can get them finished sooner too, without having extended delays.”
The NIH is focusing particularity on diverse recruitment, “Because that’s something we need to do much better at,” she added.
The ACTC is establishing a new Minority Outreach and Recruitment Team to support both central and local partnerships with diverse communities.
The funding opportunity announcement for trials is expected to be issued early in calendar year 2018.