December 14, 2011

IN THIS ISSUE …

NEWS AND ANNOUNCEMENTS

Researchers Form Consortium to Study Post-Cardiac Arrest Patients

Mary Ann Peberdy, Professor of Internal Medicine and Emergency Medicine, Virginia Commonwealth University

Four NCRR-funded academic medical centers — Virginia Commonwealth University, Beth Israel-Deaconess/Harvard University, the University of Pittsburgh and the University of Pennsylvania — created the National Post-Arrest Research Consortium to conduct collaborative research on post-cardiac arrest patients. NPARC expects to better understand post-arrest physiology and reperfusion injury, and to ultimately improve outcomes over hypothermia treatment alone.

Therapeutic hypothermia quickly lowers a patient’s body temperature to stabilize physiological functions in an effort to reduce the damage to the brain and other vital organs. Post-arrest treatment continues to evolve by implementing the latest techniques to ensure that patients receive the best available treatment. The newly formed NPARC plans to continue serial translational research projects to further the understanding of post-arrest physiology and improve outcomes after cardiac arrest. Read more.

New Chemical Process Traces Biological Pathways

A new chemical process developed by a team of Harvard researchers may increase the utility of positron emission tomography (PET) in creating real-time 3-D images of chemical activity occurring inside the human body. This new work by Tobias Ritter, associate professor of chemistry and chemical biology, and colleagues holds out the tantalizing possibility of using PET scans to peer into a number of functions inside animals and humans by simplifying the process of using “tracer” molecules to create the 3-D images. Learn more.

Researchers Identify Gene for Rare Dementia

By studying family members suspected of having Alzheimer's disease, researchers at Washington University School of Medicine in St. Louis have identified a gene that causes a rare disorder highlighted by memory loss and motor impairments, and that leads to an early death. The condition, known as Kufs disease, strikes middle-aged adults, but related forms also affect children and infants. Scientists say their discovery paves the way to development of a genetic test for Kufs and therapies to treat dementia, which is a hallmark of Kufs and of other neurodegenerative conditions, such as Alzheimer's disease. Read more.

New Cystic Fibrosis Treatment Shows Promise

A new study has confirmed that the drug, ivacaftor (VX-770), significantly improves lung function in some people with cystic fibrosis (CF). Ivacaftor, also known as VX-770, was developed by Vertex Pharmaceuticals with financial support from the Cystic Fibrosis Foundation. The oral medicine targets the defective protein produced by the gene mutation called G551D that causes CF. Researchers found that patients carrying G551D — approximately four per cent of all CF patients — who were treated with VX-770 showed a 17 percent relative improvement in lung function that was sustained over the course of 48 weeks. Learn more.

Fish Oil Lowers Inflammation and Anxiety in Healthy Medical Students

Ohio State's Center for Clinical and Translational Science conducted a study on the use of fish oil to lower inflammation and anxiety in healthy medical students. The results of this NCRR-funded study, published this month in the journal Brain, Behavior, and Immunity, show that supplementation with Omega-3 (n-3) fatty acids can help healthy subjects feel calmer, suggesting that supplementation could benefit unhealthy populations. The reduction in anxiety symptoms associated with n-3 supplementation provides the first evidence that n-3 may have potential anxiolytic benefits for individuals without an anxiety disorder diagnosis. Read more.

Community Representative Appointed to Community Engagement Key Function Committee

Al Richmond will take office as one of three co-chairs of the NIH Clinical and Translational Science Awards (CTSA) Key Function Committee (KFC) on Community Engagement. The KFC coordinates and facilitates activities of the community engagement cores across all of the 60 medical institutions nationwide that comprise the CTSA Consortium. Richmond is the first community representative to assume such a leadership post. Until now, leaders of the KFC have been academic researchers from the CTSA institutions. The KFC formed a subcommittee to examine the role of the community in leadership and decided to appoint Richmond as a co-chair. Learn more.

Top 10 Clinical Research Achievement Awards

The Clinical Research Forum announces its inaugural “Top 10 Clinical Research Achievement Awards” honoring outstanding accomplishments in clinical research. This national competition seeks to identify major advances resulting from the nation's investment in research to benefit the health and welfare of its citizens. The Forum is a nonprofit organization dedicated to providing national leadership in clinical research. Its mission is to generate support for clinical research and promote understanding of its impact on health and health care delivery. Winners will be recognized at the Clinical Research Forum Annual Meeting and Awards Dinner in Washington, D.C., April 18 – 19, 2012. Read more.

Principles of Community Engagement, Spanish Version Now Available

Principles of Community Engagement (Second Edition): New Resource Offers Guidance for Engaging Communities in Research. Order print copies.

Principles of Community Engagement (Second Edition), now available in English and Spanish, was developed by a partnership among the National Institutes of Health, Centers for Disease Control and Prevention, Health Resources and Services Administration, other federal agencies and community representatives to provide health care professionals with practical guidance for engaging communities in research.

Through the presentation of tools and success stories, Principles of Community Engagement provides public health professionals, health care providers, researchers and community-based leaders and organizations with both the theoretical framework and practical guidance for engaging partners in projects to advance health science and benefit communities nationwide.

The first edition of Principles of Community Engagement was published in 1997 by the CDC and the Agency for Toxic Substances and Disease Registry. Since then, the body of knowledge supporting community engagement principals and initiatives has grown. This second edition provides new information for those who are learning about and leading efforts to improve population health through community engagement. Order print copies.

EVENTS

Clinical Research Compliance Basic Training

Online Course: January 5, 12, 19 and 26, 2012, 3:00 – 5:30 p.m. CST

Live Course: February 6 – 8, 2012, 8:30 a.m. – 5:00 p.m. CST

The Northwestern University Clinical and Translational Sciences (NUCATS) Institute designed this training program to meet the needs of clinical research coordinators who have less than one year of experience or who have never received formal training. The class provides practical information to get students “up and running” in the clinic, with many tools and templates to assist with study implementation. Topics include: Informed Consent, Clinical Trial Initiation and Budget Negotiation, Regulatory Documents, Subject Recruitment, Compliance and Retention, Drug Compliance, IRBs, HIPAA, Adverse Events, Safety Monitoring, FDA Forms, Procedures and Audits and more. For more information, please e-mail nucats-ed@northwestern.edu or visit the NUCATS website.

CTSA Committee Meetings and Activities

View the full CTSA Committee Meetings and Activities calendar on CTSAcentral.org.

FEATURES

UNM CTSC Leads Rocky Mountain West Consortium

Richard Larson, CTSA Principal Investigator and Vice Chancellor for Research, UNM Health Sciences Center

The Rocky Mountain West region, home to the University of New Mexico (UNM), includes rich cultural and ethnic diversity as well as communities separated by hundreds of miles of mountainous terrain. A rapidly changing region that faces health care accessibility challenges, this area is fertile ground for partnerships dedicated to moving health discoveries from the lab to the bedside. In order to strengthen research collaboration throughout the region, universities from New Mexico, Idaho, Nevada, Wyoming, Montana, Alaska and Hawaii formed the Mountain West Research Consortium (MRWC). The purpose of the consortium is to better integrate the activities of NCRR-funded Centers of Biomedical Research Excellence (COBRE) and IDeA Networks of Biomedical Research Excellence (INBRE) in the region.

As a recent recipient of an NCRR Clinical and Translational Science Award, UNM and its Clinical and Translational Science Center (CTSC) are uniquely positioned to lead the regional consortium's larger scale, clinical research collaboration efforts by better integrating UNM CTSC research, education and training activities with the regional COBRE and INBRE programs.

“Through collaboration that builds on individual institutional strengths and expertise, we will expand regional research capacity to increase access to special southwest populations,” said Richard Larson, M.D., Ph.D., CTSA principal investigator and vice chancellor for research at the UNM Health Sciences Center. “And, by sharing specialty expertise, technology and health data, integrating our work, and increasing research capacity, we will accelerate our ability to address the very unique needs of underserved populations throughout the Southwest Mountain Region.”

The MWRC merges research resources, technology and populations to conduct faster, more meaningful studies. Currently, MWRC is developing a coordinated approach to diabetes and obesity, aiming to more rapidly introduce study findings into health care practice throughout the region. In addition, MWRC already has developed several programs, including one at the UNM CTSC to encourage Mountain West region students to pursue biomedical research careers. They also have formed a regional pre-grant submission review program for junior faculty. Mock study sections for MWRC schools provide insight on how NIH grant applications are reviewed for scientific and technical merit.

For more information, visit the UNM CTSC website.

CTSA's Comparative Effectiveness Research Committee Advances Patient-Centered Outcomes Research

Clinical and Translational Science, Volume 4, Issue 3, pages 188–198, June 2011

Recognizing the importance of patient-centered outcomes comparative effectiveness research (CER), the CTSA Consortium created the CER Key Function Committee (KFC), dedicated to advancing this burgeoning field of research. CER compares medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies to provide information to patients, providers and decision-makers about different health care options. This approach to research provides more information on different options for patients to consider, which will ultimately improve the quality of health care. The CER KFC plays an important role in advancing CER, in line with National Institutes of Health CER priorities.

After launching in December 2009, the CER KFC spearheaded two CER stakeholder forums in 2010 to better understand the research landscape and identify priorities and opportunities for collaboration among clinicians, researchers, patients and organizations. The CER KFC established several key areas on which to focus: community and practice engagement; research infrastructure using observational and clinical trial designs; education, training and workforce development; informatics, information technology and electronic health records; and methods development. Stemming from the stakeholder discussions at the CER Forums, the CER KFC went on to tackle several patient-centered CER projects aligning with these key areas. In addition, bringing forward several years of preliminary work, the CER KFC Methods Workgroup published “A CTSA Agenda to Advance Methods for Comparative Effectiveness Research,” in the Clinical and Translational Science journal.

BERD Watch: Recommendations for Designing Pilot Studies

Biostatisticians from the Biostatistics, Epidemiology and Research Design (BERD) units at the University of Pittsburgh, Mayo Clinic, Medical University of South Carolina and the University of North Carolina collaborated on an article in the October issue of Clinical and Translational Science. The authors recommended pilot study design improvements that would enable researchers to test the measures, procedures, recruitment criteria and operational strategies used in subsequent, often larger, studies. CTSA institutions regularly conduct such pilot studies.

The collaboration arose from a breakout session at a 2010 meeting of the BERD Key Function Committee, during which a small group of interested BERD investigators met to discuss common problems associated with pilot studies. A poorly planned pilot study could produce “negative” findings that may preclude the success of subsequent studies, thus discouraging investigators from conducting further research and drawing valuable conclusions. The published recommendations are intended to enable clinical and translational scientists to develop strong pilot study proposals that provide a compelling justification for conducting the study. For example, the recommendations address the need for an analysis plan that aligns with the study aims and a strong justification for the study’s proposed sample size. As pilot studies are designed with greater rigor, the results from broader, subsequently studies undoubtedly will improve.

Read more about this BERD Success Story on CTSpedia.

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IN THIS ISSUE …