Guest Contribution: Standard Bearers
by Rebecca Kush, Ph.D. and Tanyss Mason
January 2007
A commitment to data standards will enable a link from clinical research to the everyday practice of health care.
As the current progression toward data standards adoption gains momentum in the heavily regulated pharmaceutical industry, many thought leaders dream of establishing a true link between health care and clinical research.
In the keynote address at the Clinical Data Interchange Standards Consortium (CDISC) International Interchange meeting in September 2006, U.S. Food and Drug Administration deputy commissioner and chief operating officer Dr. Janet Woodcock said, “Once we can make the link from health care to the [drug] development process, we will bring about an explosion of knowledge … we will think back of us today as blundering in the dark.”
To facilitate the marriage of these disciplines, CDISC and the Health Information Management Systems Society (HIMSS) are collaborating to accelerate the use of standards to share data. Production standards for clinical research data interchange are critical, since they allow exploration into how best to develop a link with health care data standards. “The CDISC Board has established linking the CDISC domain to health care as a strategic priority,” says David Hardison, CDISC board chair and vice president of life sciences for SAIC, a San Diego, Calif., USA–based systems, solutions and services company.
Practices for collecting clinical research data that are not based on standards are less efficient, and more importantly, they unnecessarily burden investigative site personnel. For example, a 2005 CDISC survey found that 68 percent of investigator sites have two or more research data collection systems in use in addition to their current (paper or electronic) health record system for collecting patient data. Moreover, 17 percent of sites have five or more systems in use. Multiple systems with varied data collection requirements pose a real pain point in the data entry processes at investigative sites. Also, having electronic data capture systems separate from the health record system necessitates data re–entry and invites errors in transcription.
The collaboration of CDISC and HIMSS is aimed at leveraging the use of standards to enable an efficient process where data can be entered once to satisfy the requirements of both the patient health care record and the clinical research protocol. This process will aid in eliminating multiple data collection systems at an investigator site, and will improve data quality while saving both time and money, and facilitating clinical research at sites.
The CDISC–HIMSS collaboration will demonstrate this concept through an integration profile called Retrieve Form for Data–capture (RFD), which is based on the methodology of Integrating the Healthcare Enterprise (IHE). This work originated in 2004 with a CDISC proof–of–concept project called Single Source. Opening the door for semantic interoperability between health care and biomedical research, Single Source laid the foundation for the current IHE Integration profile, RFD. This profile enables an electronic health record system to host an external data capture form to fulfill the data needs of a related agency or organization, such as a clinical trial sponsor (clinical research data), the FDA (public safety information) or the CDC (biosurveillance). “RFD takes the first step toward interoperability, leveraging the clinical workflow between health care and clinical research,” says Didi Davis, director of IHE at HIMSS. There are plans to demonstrate the profile for use in four specific scenarios: clinical trial execution, post–marketing safety surveillance, clinical trials registries and bio–surveillance.
Collaborations and joint development of standards and open source models are excellent means to ensure that standards are accepted on a global, industry–wide basis and realize the full benefits to the entire clinical research industry. According to Gartner, based upon its experience with other industries, the adoption of such standards has a potential value to the pharmaceutical industry of $6 billion to $8 billion. More importantly, standards can help researchers and clinicians more efficiently and effectively assess the safety of new therapies to the benefit of all.
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