The College of Nursing & Healthcare Innovation has launched an interdisciplinary initiative with the formation of the Center for Healthcare Innovation & Clinical Trials (CHI&CT) to help bring innovative health care products to market.

The center is in partnership with InnovationSpace, an ASU entrepreneurial joint venture with the College of Design, the Ira A. Fulton College of Engineering, and the W. P. Carey School of Business and Arizona Technology Enterprises (AzTE).

The purpose of CHI&CT is to teach students how to develop products that create market value while serving real societal needs and minimizing impacts on the environment. The clinical trials initiative is funded by the Kauffman Foundation’s “University as Entrepreneur” program as part of a five-year grant to ASU.

Linda Mottle, a clinical associate professor at the college, has been named director of the center. She has more than 30 years experience in the health and clinical research fields as an administrative manager, nursing clinician and organizational leader, specializing in health program and clinical research development, in addition to intensive cardiac care.

“This innovative center will serve as the focal point among biotechnical organizations, health care institutions and clinical researchers,” says Bernadette Melnyk, the college’s dean and a Distinguished Foundation Professor in Nursing. “It will attract scientists and health care practitioners who have innovative ideas for products to improve health care, but who need assistance in actualizing their ideas through design, clinical trial testing and taking their product to market. Unique to this center is the clinical trials component, which will allow gathering of solid evidence to support product use for sustained solutions in health care institutions.”

The center also will have an educational component where interdisciplinary students can learn the process of translating innovative ideas into the design and testing of new health care products and approaches. Specifically, the CHI&CT has developed a new graduate certificate that has been submitted to the university for approval.

It is anticipated the 15-credit-hour graduate certificate for clinical research management will be approved to be offered in January. The center also will offer an interdisciplinary master’s degree in clinical trials management, and pre- and post-doctoral mentor programs for research scientists at a later date.

ASU entrepreneur initiative

“This initiative advances the ASU entrepreneur initiative by launching an innovative center, which to our knowledge, is the first of its kind in the country,” Mottle says. “It will create a national hub for clinicians, scientists, and collaborating health care institutions and community partners to advance health care through the creation of evidence-based innovative products and approaches that improve the health care system and create a cadre of interdisciplinary innovators, which the field urgently needs.”

The center already has conducted a low-risk clinical trial on a cardiographic impedance device approved by the Food and Drug Administration (FDA).

Center looks at health care needs

One of the challenges in the medical technology industry is that most new technologies do not result in obvious gains in mortality or morbidity, so that it is important to demonstrate improvements in quality of life and economic advantages, Melnyk says. More health care providers and payers want to see evidence of effectiveness in community settings rather than just efficacy in the carefully controlled settings that characterize data gathering for purposes of regulatory approval. The College of Nursing & Healthcare Innovation has the infrastructure in place to conduct these specific types of trials and product assessments in collaboration with its health care institutional partners.

The new center plans to work with interdisciplinary ASU scientists and community health care institutions and practitioners, biomedical and biotechnical professionals to deliver breakthrough medical inventions that can eliminate the potential for errors, improve the quality of health care delivery and save lives. Equally important, the next wave of medical technology innovation will address the cost effectiveness concerns that pervade government and society and will seek to meet the growing needs of an increasingly well-informed patient population that demands more effective, more efficient and less-invasive treatment options.

Health care networks and community biotechnical partners

The ASU nursing faculty and college’s new master’s degree in health care innovation program provide existing collaborations with numerous health care institutions and medical product developers and a long history of substantive research in health care process, evidenced-based practice, nursing process and clinical research. Current clinical research projects generally evaluate already developed and FDA-approved products.

The College of Nursing & Healthcare Innovation operates five community-based health centers and an advanced student clinical simulation lab that provide an extensive internal network of clinical trial sites. The nurse-managed centers include the ASU Health Center on the Downtown Phoenix campus that provides services for 6,800 ASU students and employees, thus giving the college direct access to potential test subjects.

Mottle says the college plans to expand the types of clinical trials and clinical research opportunities with many of the more than 400 health care institutions in Arizona that are contracted clinical educational sites for nursing students and also provide additional external clinical research sites and cooperative efforts for clinical trial through extensive health care institutional and clinical research networks.

The College of Nursing & Healthcare Innovation is ranked in the top 8 percent, or 32nd out of 396, of graduate colleges of nursing by U.S. News & World Report. Its pediatric nurse practitioner program was listed 13th in its peer group in the same survey rankings.

The college has an enrollment of more than 1,800 students and more than 7,600 graduates.

For information on the CHI&CT, visit the Web site http://nursing.asu.edu/chict or call (602) 496-0684.