Clinical Research Information Exchange

Country: United States

Organization: CRIX International

Focus of activity - Technology

Year the initiative began (yyyy) - 2007

Main barrier addressed: Monopolies of knowledge
Main insight addressed: Simplify through technology

Define the innovation - What is the main focus (product, services, etc) of your innovation? Who are the primary beneficiaries? How does it make health and/or health care more affordable, accessible, and simpler to achieve/use? How does it differ from what currently exists in the market? In the clinical research arena, fewer new therapies are being approved by regulators while research costs continue to escalate—and new therapies take as long as ever to reach patients. With the public and the U.S. Congress increasingly skeptical of the value, effectiveness, and safety of clinical research, a visionary group of professionals drawn from across the breadth of the clinical research community has committed to address these issues through the creation of a Clinical Research Information eXchange (CRIX). Such an exchange will provide faster, less expensive, and completely secure alternatives to the exchange of regulated clinical research information, and will create improvement opportunities, in areas such as the monitoring of safety, that otherwise do not exist.

An information exchange consists of a secure, standards-based information platform coupled with low-cost processes and tools. Such an exchange will act as a hub capable of receiving, storing, and sending regulated information. This hub has spokes that can reach out to anyone involved or interested in biopharmaceutical research and products. With the entire clinical research community— patients, patient advocates, hospital groups, academic research centers, sponsors of new therapies, and health authorities—connected through this hub, CRIX is much more efficient than a traditional model of one-to-one connections. The broad adoption of such a platform will allow for faster, increased access to information, increased opportunities for collaboration, and the efficiencies of scale afforded through centralization.

- Less time on paperwork means more time devoted to improving patient outcomes
- Lower transactional costs mean more money for research
- Electronic exchange reduces the chance for human error
- Faster communication means faster new treatments for patients
- Easier processes encourage greater participation in life-saving clinical trials

Context for Disruption: - Describe how your innovation is transforming traditional health or related systems in the short and long term. The centralization of data through a common platform has the potential to revolutionize the clinical research and regulatory environments. The clinical research community has been experiencing a fundamental shift away from closed systems of scientific exploration and towards integrated, collaborative scientific efforts. This includes exploring the potential to make safety reporting and clinical study data capture a seamless part of a physician’s office maintaining an Electronic Health Record. At the heart of this transformation is the need for real-time, dynamic information flows and feedback loops. This level of collaboration is impossible in the current research environment—the creation of an e-platform is essential to facilitate the clear flow of information.
In the short term, a CRIX platform will:

- Facilitate secure transmission of clinical research information between sponsors of new therapies, researchers, collaborative business partners, and regulatory authorities;
- Develop a common set of registries, including an investigator registry, that can be leveraged across a variety of applications;
- Promote the adoption and use of selected electronic data standards, standardized terminologies, e-transactions, and e-submissions;

Delivery Model - How does your innovation reach its target populations? What mechanism(s) (e.g., communications, distribution channels, etc.) do you have in place? What is your current market penetration? How do you measure this? CRIX consists of a suite of services and tools offered through a secure, standards-based information platform, or web-based portal. CRIX currently has over 100 member organizations each of which have direct access to hundreds if not thousands of potential end users. Since the use of the CRIX portal has the potential to save larger pharmaceutical companies and research organizations millions of dollars annually, these organizations will have a strong incentive to drive usership among the clinical research community. Through this mechanism we expect to quickly reach between 10,000 and 25,000 clinical researchers and ultimately approximately 250,000 clinical researchers.

Key Operational Partnerships - What key partnerships have you established to make your disruptive innovation model possible? Who are your partners (business, social, government, other) and what are their roles? How central are these partnerships for your initiative. The CRIX International Association is an independent, privately funded, not-for-profit organization with offices in Reston, VA. The company was formed in December, 2006 with the vision of a public-private partnership to oversee an electronic information exchange.

While initial contributions came from Pfizer, Amgen, and Novartis, CRIX International encompasses a broad range of stakeholders. Represented within the CRIX community are hospital groups, patients, patient advocates, academic research centers, trade and standards-setting organizations, bio-pharmaceutical companies, and industry service providers. Many of these community members participate in CRIX International activities through working groups and regional advisory councils. Moreover, CRIX International has received formal endorsements from the following companies: Accenture, Clinical Data Interchange Standards Consortium (CDISC), IBM, Health Level 7 (HL7), Northrop Grumman, Sanofi-Aventis, Science Applications International Corporation (SAIC), Signatures and Authentication for Everyone (SAFE), and Theravance.

Financial Model - Describe the financial model for your innovation. What percentage, if any, of the total operating costs does earned income (from products, services, or other fees) represent? CRIX International plans a funding approach that is based on a set of initial contributions from stakeholders within the healthcare community. These initial contributions will be sufficient to cover cash flow needs for two to three years in order to create the foundation of the public-private partnership and to adequately support and sustain the development and deployment of an initial service.

Once the initial service is implemented, usage fees will be sufficient to cover sustaining and maintenance costs. Surplus revenues would be used to build reserves that can be reinvested towards incubating and developing additional services for the benefit of the healthcare community.

Early financial estimates and models used by CRIX International project that the system can reach self-sustainability from a service fee perspective within a period of three years, even with relatively low transaction volume assumptions.

What is your annual operating budget? $2,000,000
What are your current sources of revenue? (please list any sources that are foundation grants) To date, CRIX International has received funding through membership fees from Pfizer, Amgen, and Novartis. Our business model, however, anticipates our primary source of revenue will be user and associated membership fees that will allow access to the information exchange. The net effect is to create a sustainable business model that will allow CRIX International to oversee the operation of the exchange and reinvest proceeds to expand the exchange for the overall benefit of the healthcare community.
We are specifically targeting a range of services which may not deliver a positive return on investment to CRIX International, but would significantly expand access to information across the healthcare community. Examples of such services include a clinical trial matching service and spontaneous adverse event reporting services. The clinical trial matching service will allow cancer patients to more easily find and participate in clinical trials for therapies specific to their illnesses. Spontaneous adverse event reporting services could dramatically accelerate reporting to regulatory authorities and potentially provide real-time feedback to physicians and patients.

Effectiveness - What has been the measurable impact of your project to date? How many people have benefited from your program in total? What policies, communities, or institutions have been influenced to make fundamental changes because of your work? The focus of our first year has been on the development of our technology and our community support. As the technology is not yet ready for production, our impact is best measured by the growth of the CRIX Community. Support for CRIX International has grown from our initial two founding members in December 2006 to more than 140 members as of June 2007.

We have engaged the CRIX Community primarily in two ways: one, through a loosely structured working group whose goal is to gather requirements for our first service, and two, through the formation of the North American Advisory Council (NAAC). Both the working group and the NAAC have representation from more than fifteen organizations. The NAAC is the first of several planned regional advisory councils that will provide guidance and set service priorities for CRIX International.

Which element of the program proved itself most effective? The most effective element of our program thus far has been the realization by the healthcare community of the potential savings of time and money and the expansion of access to information that the CRIX portal could provide. This realization has been the primary driver of our rapid expansion of membership and community interest even prior to the availability of CRIX services.
Number of clients in the last year? We expect to launch our initial exchange platform in September 2007 and begin deliver of services by year-end 2007.
What is the potential demand? We anticipate that up to 300,000 clinical researchers worldwide could see benefit from our exchange in the initial stages. Our estimates suggest that benefits to the patient population could be an order of magnitude greater than the direct usership among the healthcare industry participants.

Scaling up Strategy - What is your priority for the next 3 years and please describe why. Our long-term priority is to deploy more services on the CRIX platform, effectively building out the information exchange. The interoperability of these services will allow users to cross-reference data across knowledge domains. For example, clinical investigators will be able to cross-reference adverse events with specific patient populations (impossible in the current environment). The CRIX Community will realize the benefits of a clear flow of information afforded by the CRIX platform in a variety of ways.

Stage of the initiative: Start up
Expansion plan: Additional functionality being explored encompasses authoritative databases and registries to meet the needs of a broad set of research processes. These registries include a study registry, a service provider registry, and others. In the exploration of additional services, the CRIX Community has identified the following areas of specific interest:
• Clinical trial matching service
• Spontaneous adverse event reporting services
• JANUS SDTM data warehouse and reporting environment
• Collaborative review environment for processes such as developing the Structured
Product Label (SPL)

Origin of the Initiative - Tell the personal story that will help people connect to your work. How did the initiative start? Was there a particular individual or event driving the idea? Tell the reader the story behind the innovation. In 2003 & 2004, the National Cancer Institute (NCI) & FDA formed a task force with the goals to speed new research discoveries to the public & lower costs by implementing a shared, standards-based infrastructure for regulatory data & document submission, review & analysis. At the same time, several members of the biopharmaceutical industry were exploring similar shared infrastructure initiatives. Recognizing the need for a common solution, the CRIX initiative was born out of these separate initiatives in 2005 through the NCI. In December 2006, CRIX International was formed under a collective vision as a public-private partnership to oversee an information exchange. Through broad stakeholder participation in various councils & working groups, CRIX International will leverage the vast experience of the CRIX Community to provide the definition, development, & delivery of valuable services

Contact Information:

Jenn Whinnem
Communications Manager
CRIX International
(not-for-profit)

Submitted by: whinnemj

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