Clinical research is essential for advancing medical science and improving health care. However, performing clinical research can be very complex.
Even relatively simple clinical trials involve collecting, processing, analyzing and reporting large amounts of health information and study data.
To address the growing management and organizational needs of clinical research, a new field of biomedical informatics has emerged: clinical research informatics (CRI).
Experts at the UC Center for Health Informatics (CHI) and the Center for Clinical and Translational Science and Training (CCTST) have made advancing the science and practice of CRI a major focus of their work, and now they are focusing on teaching others about this important new field.
CRI applies biomedical and health informatics approaches to address the challenges of planning, conducting and distributing the results of clinical research.
“While several programs exist around the nation to teach students about biomedical informatics in general, few, if any, focus specifically on the field of CRI,” says Peter Embi, MD, assistant professor of medicine, director for the UC Center for Health Informatics and director of clinical and translational research informatics for the CCTST.
UC has recently partnered with the American Medical Informatics Association (AMIA) to better prepare professionals in the health, biomedical and information technology fields to handle informatics issues in the workplace.
UC is the fifth university nationally to partner with AMIA in its 10x10 program, focused on training 10,000 people in biomedical and health informatics by 2010, and is the first to offer a course specifically focused on CRI. Embi will lead the 10x10 program being offered at UC.
“CRI is a very important and rapidly emerging domain within the biomedical informatics field,” he says. “Training more professionals and leaders in CRI will help us better and more quickly translate the growing number of biomedical advances being made into improvements for people’s health.”
The CRI 10x10 course, which will be offered beginning in January 2009, includes online multimedia presentations along with access to instructional materials and a face-to-face component at the conclusion of the course.
“Students who complete the course have the option of continuing their education and training in this field through programs offered at UC,” he adds.
Embi says the program will not only highlight the key challenges and opportunities facing CRI but also will introduce students to key models, approaches, tools, regulatory/ ethical issues and initiatives driving their development and practice.
“The program will teach participants about key issues in clinical research and the solutions to them based on established and emerging informatics principles and approaches,” Embi says. “This training will enable participants to serve as champions in local health care, research and industry settings and provide a foundation for those who wish to delve more deeply into this rapidly developing field of study.”
He adds that this program will attract people from all over the nation that have a stake in clinical research and the way research data is managed to advance science, including academic health centers, pharmaceutical companies and research organizations.
But this is only one way that CRI is being advanced at UC.
Embi has just received an National Institutes of Health grant to continue his research that examines the best use of electronic medical records to improve recruitment in open clinical trials. This is done by alerting medical professionals when a patient is eligible to participate.
“We are currently trying to see how effectively this point-of-care clinical trial alert approach will work across different health care settings,” he says. “This is critical because if we can’t find enough people to participate in studies, we can’t complete the studies and advance science.”
He and colleagues at the CHI and CCTST are also partnering with UC’s health partners to create a “research data warehouse,” which will organize electronically collected health and research information in order to help scientists access data.
“Currently, the data needed by researchers is spread among many different systems, making it difficult for them to gain access and do their important work,” he says. “Researchers need to be able to access the data they need more efficiently and effectively.
“At UC, we are doing our part to define and develop this important and rapidly developing field,” he continues.
“As we continue our work, we hope to advance CRI and grow our status as a regional and national leader in this area.”