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Diabetic Retinopathy Network Helps MDs and Patients Compare Treatment Options
In 2013, UNM became a certified site for the NIH-funded Diabetic Retinopathy Clinical Research Network, administered by the National Eye Institute. UNM’s first trial in the network was a comparative effectiveness study to test the efficacy and safety of three different drug therapies for diabetic macular edema, a condition that causes the retina to swell and without treatment can rapidly lead to loss of central vision.

Findings from this study were recently published by the New England Journal of Medicine. Network researchers recruited 660 patients from 89 clinical sites and randomly assigned them to receive one of the three treatments, which range in price from $50 to almost $2,000 a dose. They found that the treatments are equally safe and effective for most patients, though Elyea, the most expensive, was more effective for patients who had poorer vision at the beginning of the study.

Arup Das, MD, PhD, professor of Surgery and chief of the UNM Hospital Ophthalmology Division, and research coordinator Linda Friesen led the study here at UNM. CTSC’s clinical research unit assisted with phlebotomy and sample processing. Read more about the study in the New York Times and NIH press release.

CTSC Launches GCP Initiative
UNM CTSC is leading the way for enhancing clinical research professional training at the UNM Health Sciences Center and as part of a new CTSA-wide initiative to standardize clinical processes and improve training programs. All CTSC research staff are currently completing training and certification in Good Clinical Practice (GCP), an internationally recognized standard for ethical and scientific quality in clinical research.

“Performing clinical research in a standardized way is important for ensuring safety and well-being of human research participants, study efficiency and data integrity,” said Amy Overby, CTSC Clinical Research Operations Manager. “Comprehensive GCP training and in-house certification for CTSC staff will align our institution with the highest level of clinical research performance and standards recognized by NIH, FDA and industry.”

UNM CTSC’s initiative coincides with a CTSA consortium project, supported by a supplement award from the NIH National Center for Advancing Translational Science, to enhance training and qualifications for clinical research professionals across the consortium. Members of CTSC’s leadership and management team attended a meeting in Chicago, November 3 – 4, 2014, to discuss best practices and strategies for standardizing research training for clinical and translational science. The CTSAs, said Overby, could make a significant impact in this area and be a model for conducting clinical research at academic institutions. Currently, only approximately 23 percent of CTSAs provide GCP training for their research staff, according to a survey of CTSA principle investigators.

The GCP curriculum for CTSC staff includes instruction on data quality, source documentation, informed consent, clinical study protocols and reports, FDA inspection and how to document, manage and report protocol deviations. CTSC hopes in the future to be able to provide this training to other clinical research divisions and centers at the UNM Health Sciences Center and partnering institutions.

News and Events Archive

Pilot Update
The CTSC Pilot Program RFAs are open! For more information and to view current opportunities, please visit the Funding Opportunites homepage.

Investigator & Staff Profiles
CTSC Investigator of the Month
Nate Link, MD
Nate Link, MD, is an assistant professor in the UNM Department of Pediatrics and provider at the Healthy and Fit Children’s Clinic, where he works closely with overweight and obese children and their families to reduce health risks and help them make lifestyle changes. Link is also an advocate in the community to build awareness about the life-long health effects of childhood obesity and importance of diet and physical activity. He has worked with several Albuquerque public schools to build school gardens and develop nutrition curricula.
Read more about Dr. Link
CTSC Employee Profile
Vanessa Garcia
Vanessa Garcia is a radiological technologist specialist and member of the CTSC’s bionutrition unit. As the CTSC’s DXA expert, she has assisted many investigators in designing protocols that include body composition assessment technologies, as well as with collecting biometric data and other clinical study activities.
Read more about Vanessa

Spotlight Archive

Clinical & Translational Science Center
The UNM CTCS is supported in part by the Clinical & Translational Science Awards (CTSA). The CTSA initiative is led by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health.

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