Hub-and-Spoke Platform Ready to Roll

Clinical Research Information Exchange (CRIX) International plans to hit the ground running in 2008 by launching its much-anticipated CRIX technology platform early in the year. Over the past several months, a number of news stories have been written on the topic, and the organization has been working hard to make its goal of "transforming clinical research" a reality. The launching of its e-platform brings CRIX one step closer to this goal, and in a sense it is the culmination of years of effort-even though the company just turned one back in December.

Long and winding tale

In 2003, the National Cancer Institute (NCI) teamed up with FDA to create the Interagency Oncology Task Force (IOTF). Among their goals: Get new therapies to the public faster. To achieve this, IOTF would implement a shared, standards-based, electronic infrastructure for regulatory data and document submission. Around the same time, according to Susan Dubman, former director of biomedical informatics applications at NCI and the current chairperson of the CRIX North American Advisory Council (NAAC), a number of biopharms had the same idea for a shared infrastructure and were exploring their own initiatives. "The Clinical Research Information Exchange (CRIX) initiative was born out of these separate initiatives," said Dubman, "and launched in late 2004."

The following April, NCI formed the CRIX Steering Committee, made up of 30 to 35 members from government, industry, academia, patient advocates, and standards groups (i.e., the stakeholders of the public–private partnership known as CRIX). Their first order of business: the Federal Investigator Registry for Biomedical Informatics Research Data (FIREBIRD). Firebird sought to make the FDA's 1572 registration process for investigators more efficient.

The here and now

Despite early success with FIREBIRD, the Steering Committee realized that in order to meet the larger needs of the clinical research community, they would have to look beyond CRIX. So, in December 2006, the CRIX Community formed CRIX International and brought their case for a shared-technology, standards-based information exchange before FDA. "While we have taken the initial steps to form an entity that embraces a public–private partnership," Pfizer's Debra Bremer, vice president of development and medical information, testified at FDA's Part 15 Meeting, "it could readily be merged into an existing, strategically aligned nonprofit organization." Enter today's CRIX International (www.crixinternational.org).

"We are a not-for-profit, [and] we are intended to function as such-an industry type consortium controlled by industry and the regulatory bodies," says James Bland, executive director of CRIX International, "and we oversee the operations of the organization"-one that has been on the move for over a year. Following initial capital from Pfizer and Amgen, and then Novartis in early 2007, the not-for-profit formed the NAAC featuring members from CDISC, Eli Lilly, and AstraZeneca; chose Northrop Grumman (Los Angeles, CA) as their operating partner to host the platform; and selected TriCipher (Los Gatos, CA) to provide an authentication infrastructure.

Now they're expected to launch the CRIX platform and serve up their first offering: a FIREBIRD-based electronic investigator registry that collects and aggregates data, storing it on a secure shared system where CRIX members can access it, eliminating the need for investigators to fill out required paperwork every time they sign on to a study. Instead, it's a single, sign on deal that streamlines the credentialing process.

But that's just the first step. CRIX International plans to expand upon this application and incrementally roll out a "suite of services," including patient matching, adverse event reporting, clinical data management-the list goes on. Tools will be added according to market needs, says Mark Vermette, project manager at CRIX, who explained that it's a subscriber model, with fees based on usage and CRIX taking little overhead.

What the organization does take is an idea from other industries that have implemented a consortium exchange model to help drive down costs, improve cycle times, and create efficiency across the board. And with so many in industry on board already-a result of their involvement from the very beginning-CRIX International already has the financial backing and support, it appears, to truly bring this type of efficiency to the clinical research industry.

What would seal the deal is backing from FDA, which has remained mum since CRIX International answered the agency's RFI back in May 2007. If they do decide to get on board, the EMEA will follow suit. "The EMEA has already agreed to join," Vermette told Applied Clinical Trials, "their contingency is that FDA signs up."