Seeking to gain efficiencies, cost savings and faster enrollment timelines for vaccine clinical trials, North Carolina-based PRA Health Sciences has formed a non-exclusive strategic partnership with the Alliance for Multispecialty Research (AMR), a geographically dispersed network that represents 17 independently owned, multi-therapeutic clinical research investigative sites.
The collaboration—among the first to engage a single site network for vaccine trials—enables PRA to have detailed information about the quality and capabilities of each site, with Tennessee-based AMR providing clinical study services including vaccines and several bioterrorism-related government sponsored programs support. A key goal is to make it easier to identify appropriate patient populations and implement efficient solutions to smarter vaccine development, according to Brenda Atchison, AMR’s chief executive officer.
“We are pretty excited about this collaboration, which we have been working on for three years,” said Atchison. “Basically we operate as a core team, with a group of vetted sites and the advantages of strong collaborations with CROs and sponsors. But unlike most CROs, we provide sponsors with due diligence on these specific sites before receiving the actual study, which helps sponsors with feasibility, so they don’t have to worry about picking and evaluating sites.”
AMR believes that its sponsors meet better enrollment timelines. Atchison cited subject retention rates between 93% and 100% for its previous clinical trial studies, which allows for successful support of small to mid-size vaccine trials.
For PRA, the collaboration is a chance to identify patient populations needed for vaccine studies and work with one of the most cost-effective clinical research site networks, noted Frank Hijek, PRA senior vice president for strategic drug development.
“Together, we can help sponsors get vaccines to the people who need them,” Hijek said in a prepared statement. He added that PRA has provided support for 10 approved vaccines in the past five years.
PRA’s vaccine experience includes phase I through phase IV adult and pediatric studies involving nearly 213,000 participants at more than 3,000 sites around the world, while AMR member-centers have enrolled nearly 50,000 volunteers across all age ranges in vaccine trials alone and including several bioterrorism-related programs conducted under government contracts.
Under the strategic partnership, AMR—which is an alliance, rather than a site management organization—provides, at no cost to PRA, self-coordination services that maximize consistency across all the sites. Instead, the network members pay yearly dues to AMR, which helps all the sites with the study design development and with writing the protocols. For each clinical trial involving the alliance, AMR assigns an internal chairperson who provides internal oversight.
“What we are creating is a formalized, longstanding collaborative relationship with PRA,” said Atchison. “We work on behalf of our sites on immediate program development, proposal development, budget assistance and management assistance. Before CROs’ bids are ever in, we participate actively on behalf of our members. And we are involved from day one, and not just in vaccine trials but with other trials—all at very early stages that no one else does.”
AMR, which recently completed a major Ebola study that enrolled 150 patients at multiple sites, also has provided support for more than 10 approved vaccines in the past five years. Although the majority of vaccines are for children, there are industry projections that the adult vaccine market is expected to double by 2020—especially in the area of infectious diseases that affect people globally.
In a joint statement, both PRA and AMR stated the collaboration is expected to identify patient populations needed for vaccine studies with the ultimate goal of getting vaccines to market more quickly than in the past.
“This is an ideal collaboration,” said Hijek. “It combines the expertise of PRA, one of the world’s leading contract research organizations, and AMR, one of the most effective clinical research site networks in the industry. Together, we can help sponsors get vaccines to the people who need them.”
Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology.
This article was reprinted from Volume 19, Issue 40, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »