Three prominent cardiovascular researchers have teamed up to provide what they say will be a more efficient IT-based process for moving cardiovascular devices through the investigational process. The partnership will combine clinical and analytical expertise with core laboratory firepower to give sponsors a streamlined, high-quality product that better meets regulatory demands, one of the directors, Jeffrey J. Popma, MD, said in an exclusive interview.
Their long-term objective is to develop a first-in-man to post-approval strategy for industry sponsors, said Popma, director of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center Angiographic Core Laboratory and an associate professor of medicine at Harvard Medical School in Boston. The collaborative alliance pairs the Angiographic and Imaging Core Laboratories of the Clinical Trials Center at the Cardiovascular Research Foundation (CRF) in New York with Popma’s laboratory in Boston.
The partnership, called CRFiCOR, will be led by Popma; Gregg W. Stone, MD, director of CRF and Gary S. Mintz, MD, chief medical officer at CRF. Stone also is a professor of medicine at Columbia University College of Physicians and Surgeons and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center in New York City.
While the alliance is new, collaboration among the three investigators is not. Popma, Stone and Mintz worked together in the 1990s when Popma established CRF’s Angiographic Core Laboratory in Washington, D.C., and they have collaborated on several studies over the years. More recently, though, they were competing for the opportunity to perform the angiographic analyses, Popma said.
Trends toward less frequent trials and more rigorous quality assurance requirements helped them realize that combining their laboratory capabilities might offer both scientific and operational value, he said. The alliance also allows the two laboratories to leverage and expand on their IT capabilities.
“Many of the sponsors want to move toward IT solutions” for rapid image transport and analysis, Popma said.
CRFiCOR will offer core laboratory analysis, including coronary angiography, carotid and peripheral angiography, intravascular imaging and structural heart disease assessment, electrocardiography, CT and MR imaging. The two laboratories have similar processes, Popma said, because they both trace their roots to his laboratory in Washington, D.C. The two laboratories, collectively, have performed imaging studies on more than 100,000 patients, according to a CRFiCOR statement.
The immediate task at hand is getting the labs in synch. “The roadmap for the short term is to integrate the quality assurance and operational pieces to demonstrate the definitions, analyses, processes and variability are comparable in our two laboratories,” Popma said. “Our next short-term goal is to work on IT integration.”
The ability of the laboratories to cross-check data will provide value for vendors, Popma said, because it will ensure internal consistency, reliability and reproducibility–critical attributes in the regulatory process. The experience of the co-leaders will also be valuable for designing rigorous trials that meet regulatory standards, Popma added.
Within a year, Popma predicted, CRFiCOR will be able to provide a cloud-based virtual data-sharing and analysis capability that will enhance quality and speed along the process. Their goal is to develop collaboratively the ability to hold a virtual investigators’ meeting and provide complete data analysis via IT, allowing international investigators to view images and discuss results simultaneously through the internet.
“At the end of the study, our quantitative angiographic results would be stored, reviewed and ready to be submitted electronically to regulatory bodies,” he said.
In the end, their sponsors must find value in their alliance, Popma acknowledged. “The burden of proof is on us to demonstrate we have an enhanced product,” he said.