Tackling US Veteran’s Issues

Saunders Vet Wall

“Let us never forget the sacrifices made by our veterans and their families, and may the research within this building bring healing to them and others.” – E. Phillip Saunders

This Memorial Day, while we celebrate and honor the many Americans who gave the ultimate sacrifice for our country, we are also reminded of the many issues faced by our veterans who have returned home.

When Phillip Saunders donated $10 million to the University of Rochester Medical Center for the construction of a new home for clinical and translational research, he stipulated that the building, which now bears his name, honor U.S. armed forces. Visitors of the Saunders Research Building may recognize the Veteran Memorial Wall, which is prominently displayed in the building’s atrium.

Because the CTSI has benefited from Saunders’ generosity and dedication to clinical and translational research, the fall CTSI Seminar Series will honor his request by highlighting veteran research occurring at the University of Rochester, the Rochester Outpatient Clinic/Canandaigua Veteran’s Affairs Medical Center, and across the country.

The series will explore research on veteran’s issues such as combating insomnia, preventing suicide, and managing pain. Other topics will include opportunities for research collaborations with the VA, how to improve the quality and evaluation of extended care for veterans, and how to become a VA researcher.

More information about the seminar series, which begins in September, will be included in the CTSI Weekly Update in the near future.

Click here to sign up for the CTSI Weekly Update.

Closing out Mental Health Awareness Month

As we near the end of Mental Health Awareness Month, the CTSI would like to highlight some mental health research projects it has funded in the past 10 years.

 

Mental Health Awareness Month is the longest running national initiative of Mental Health America. Every May since 1949, has been dedicated to fighting damaging stigma about mental illnesses while fostering awareness that these illnesses are real and treatable. The organization also provides tools to help connect people in need with services and treatment for their mental illnesses.

The following are just a sampling of the many mental health research projects the CTSI has supported.

Megan Lytle

Megan Lytle, Ph.D.

In 2014,  Megan Lytle, Ph.D., senior instructor of Psychiatry Research at the University of Rochester Medical Center, was funded by the KL2 Career Development Program to investigate health disparities in the lesbian, gay, bisexual, and transgender (LGBT) communities with a focus on suicide prevention. While the precursor risks for suicide are similar among different groups, members of diverse LGBT populations tend to have a high burden for suicidal thoughts and suicide attempts.

Lytle and her mentor, Vincent Silenzio, M.D., M.P.H., associate professor of Psychiatry Research, Family Medicine, and Public Health Sciences at URMC, delved into the racial, ethnic, and religious diversity within the LGBT community. Across the board, LGB individuals were more likely than heterosexuals to report self-harm, suicidal thoughts, suicide attempts, and depression. They also found that transgender individuals, were at higher risk for suicidal behaviors – especially if they also identified as LGB or a racial/ethnic minority.

Beau-Abar

Beau Abar, Ph.D.

The CTSI has also funded – and is currently funding – research regarding the mental health of the elderly.

Currently, KL2 scholar Beau Abar, Ph.D., assistant professor of Emergency Medicine at URMC, is trying to identify and eliminate barriers to treatment for depression in older adults. His work is focused on testing a variety of barriers to care for depression using an experimental design.

Adam Simning

Adam Simning, M.D., Ph.D.

Adam Simning, M.D., Ph.D., Psychiatry resident at URMC, performed a cross-sectional study of 190 public housing residents 60 years and older in Rochester for his Ph.D. dissertation, which was funded by the CTSI and the Agency for Healthcare Research and Quality. Under the mentorship of Edwin van Wijngaarden, Ph.D., associate professor of Public Health Sciences, and Yeates Conwell, M.D., professor of Psychiatry, Dr. Simning found that mental illness was common among older adults in Rochester public housing, but was largely untreated. Based on their findings, Dr. Simning recommended multidisciplinary collaborative care approaches to address these complex issues in the future.

 

 

 

Clinical Trials Day: A History of Fostering Clinical Research

Today is Clinical Trials Day, an international day of recognition for the scientists, study teams, and volunteers that make new health care discoveries possible. Clinical Trials Day is celebrated on May 20th each year in honor of the start of what is largely regarded as the first clinical trial.

ThinkstockPhotos-92846912

British warship similar to the one on which James Lind conducted the first clinical trial.

On May 20, 1747, a surgeon in the British Royal Navy, James Lind, randomly assigned 6 pairs of sailors afflicted with scurvy to a variety of dietary regimens. Scurvy, a vitamin C deficiency, is characterized by fatigue and bleeding gums and was common among sailors, who had little access to fresh fruit on long voyages. After 6 days on their special diets, only the sailors who were given oranges and lemons showed drastic improvement.

The idea to use citrus fruit for treatment of scurvy came from centuries of prior knowledge – dating back to Vasco De Gama’s expedition to India in 1497. However, the British Royal Navy didn’t adopt the use of citrus juice on ships as common practice, until 40 years after Lind published his results.

The story of Lind and the history of scurvy demonstrates the many roadblocks between scientific discovery and improving the health of a population. Some of these same roadblocks exist today – though, thankfully, to a lesser degree. While it may no longer take centuries to develop new ideas into life-saving therapies, it still can take several decades.

The CTSI is built around breaking through those roadblocks and facilitating scientists in moving their work forward. The institute offers services and guidance all along the spectrum of research, including the design and implementation of clinical trials, which are much more complicated and sophisticated than Lind’s rudimentary trial.

“It’s great that we have a chance at the University of Rochester to go from the inception of the idea to actually have patients coming to be evaluated [in a clinical trial],” says Giovanni Schifitto, MD, MS, Director of the Clinical Research Center and professor of Neurology at the University of Rochester Medical Center. “It’s a full circle.”

The Clinical Research Center (CRC) is an essential resource for the implementation of clinical trials offered by the CTSI. The CRC offers a safe and comfortable place for patients and study volunteers to receive treatments and employs a dedicated, knowledgeable staff that is vital to its success.

“Clinical research is very important and the research nurse is at the forefront of the process,” says Ann Miller, RN, MS, CCRC, nurse manager of the CRC. “The CRC nurses have skill sets that range from neonate to geriatric experience. In conjunction with the Bionutrition staff, Imaging Sciences, and Health Project Coordinator we benefit, and enhance, each other’s knowledge base and I think that’s been very helpful.”

Moxley CRC

Richard Moxley, MD utilizing the Clinical Research Center.

In addition to traditional nurse training for the hospital, the nurses of the CRC are required to undergo continual specialized training to keep them up-to-date on best practices in clinical research and to give them a solid understanding of each of the studies they facilitate. Each investigator that wishes to utilize the CRC must give an inservice training to explain the science behind the study as well as detailed information about what the CRC staff will need to do, when, and why, with the overall goal of making the CRC an integral part of the investigating team.

 

The CRC commonly carries over 100 studies at once. Right now, they are implementing around 80 clinical trials that aim to cure, prevent, or better diagnose 35 different diseases. From understanding the cause of cognitive decline in HIV patients to testing new drugs for rare, debilitating diseases like Duchenne Muscular Dystrophy, the CRC staff is integral to a process that offers hope not only to their study participants, but to millions of people suffering with these diseases around the world.

“We are lucky,” Schifitto says, “to have a resource like the CRC. There are institutions that don’t have such a resource and therefore cannot do certain studies.”

Schifitto also points out that the CRC is just one clinical trial resource offered by the CTSI. While the CRC aids with the implementation phase of a trial, the CTSI also offers help with designing trials, developing helpful collaborations, navigating regulatory processes, recruiting the required amount of participants – especially from populations that are typically under-represented in clinical research, training and providing study personnel, and the collection and management of clinical data.

The CTSI is also affiliated with the Center for Human Experimental Therapeutics (CHET), which was established to conduct rigorous initial investigations of new therapies for musculoskeletal, cardiovascular, neurologic, infectious/immunologic disorders and cancer. CHET facilitates initial clinical trials from many disciplines around the URMC – from vaccines being produced by the infectious disease program to innovative therapies for cancer being tested in the Wilmot Cancer Institute.

All of the resources provided by the CTSI help researchers take their ideas from the laboratory to the clinic and help put URMC at the forefront of biomedical research.  With these resources, our dedicated researchers strive to cure debilitating diseases and improve the lives of the millions of people suffering around the world.

Practice Root Cause Analysis at SCORE Half Day Seminar

ThinkstockPhotos-505250995

The registration deadline to attend the 8th Annual Study Coordinators Organization for Research and Education (SCORE) Half Day Seminar is quickly approaching.  This year’s seminar will feature a simulation of root cause analysis, a methodology to review adverse events, identify key causes and contributing factors and implement system-based solutions. Recent changes to guidelines for investigation and prevention of non-compliance in clinical trials require sponsors and often research teams (study coordinators and research nurses) to be able to perform root cause analysis.

Clinical trial protocols are designed to examine specific scientific questions while minimizing risks to patient safety and maintaining data integrity.  Clinical trials have become increasingly large and complex over the past few decades. It is not uncommon for a trial to have many sites that span the nation or the globe and study teams that may change in personnel during the trial. This increased complexity leads to greater risk of errors and non-compliance, resulting in deviations from the protocol.

Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, has set expectations that all sponsor or clinical research organization (CRO) personnel should review the monitoring plan and be prepared to perform a root cause analysis, and to implement appropriate corrective and preventative actions when deviations occur.

When things go awry in clinical research, it is essential to understand the underlying cause(s) of the error or protocol failure. Root cause analysis gets to the core of the issues, which are often related to system defects in communication, policies and processes, environment, information management and/or human resources. Depending on the root cause identified, system-based solutions are designed to reduce or eliminate the risk of the event recurring.

One thing to keep in mind is that, by their very nature, root cause analyses are not one-size-fits-all. The nature of issues and the optimal intervention will vary from site to site and from study to study. This is why it is important to do a thorough assessment of each critical issue as it arises and devise targeted solutions to prevent future issues.

To learn more about root cause analysis and the expectations for study coordinators and research nurses, register for the SCORE Half Day Seminar.

The seminar will be held on Tuesday, June 7th in the Ryan Case Method room in the URMC with live streaming available at an overflow site. Parking will be available for non-UR attendees for $6 fee.

For more information, please contact SCORE@urmc.rochester.edu.

Congratulations, Graduates!

MD Grads
This past weekend (May 13th and 14th) students from graduate, medical, and nursing programs at the University of Rochester School of Medicine and Dentistry and School of Nursing moved their tassels from right to left, marking an important milestone in their careers.  Commencement ceremonies honored the achievements and hard work of our many graduates through the weekend.

The CTSI would like to congratulate all of the University’s recent grads with special recognition for several medical school graduates who participated in the CTSI’s Academic Research Track and those supported by the CTSI during their MD/PhD program.

Josef Bartels, M.D.
Project Title: The Context, Structure, and Function of Silence in Doctor-Patient Communication
Mentor: Ronald Epstein, MD

Laura Fornarola, M.D., Ph.D.
Project Title: Determining the role of the proryl isomerase Pin1 in neuronal programmed cell death
Mentor: Robert Freeman, PhD

Michael Geary, M.D.
Project Title: Modulation of the prostanoid receptor EP4 to reduce scarring during flexor tendon healing
Mentor: Regis O’Keefe, PhD

Natalia Golub, M.D., Ph.D. 
Project Title: Longitudinal Health Outcomes in Former Refugees
Mentor: Diana Fernandez, MD, MPH, PhD

David Paul Grad HugTrevor Hansen, M.D.
Project Title: Thy1 Expression as a Marker and Therapeutic Target for Scar Formation in Capsular Constracture following Reconstruction Mammoplasty
Mentor: Richard Phipps, PhD

Kelly Makino. M.D.
Project Title: Advance Care Planning in Early Dementia Study
Mentor: Anton Porsteinsson, MD

Kevin Makino, M.D., Ph.D. 
Project Title: An Exploration of the Role of Public Health Insurance in Moderating the Effects of Low Family Income on Children’s Educational Success
Mentor: Bruce Friedman, PhD

David Paul, M.D.
Project Title: Using DTI to measure changes in occipital lobe white matter after decompression of the optic chiasm
Mentors: Brad Mahon, MD and Edward Vates, MD, PhD

Kyle Rodenbach, M.D. 
Project Title: Crystatin-C-based renal reserve in children with history of hemolytic uremic syndrome-associated acute kidney injury
Mentor: George Schwartz, MD

Lauren Roussel, M.D. 
Project Title: Evaluating Upper Extremity Function Following Mastectomy in Reconstructed and Non-Reconstructed Women with Breast Cancer

Helen Wei, M.D., Ph.D.
Project Title: Astrocyte regulation of the cerebral microcirculation
Mentors: Maiken Nedergaard, MD, DM.Sc. & Edward Vates, MD, PhDRodenbach Grad

For more photos, visit the University of Rochester Commencement 2016 webpage.

Photo credit to University photos / J. Adam Fenster

NIH Introduces the Women of Color Research Network

wocrnThe Women of Color Research Network (WoCRn) is an online community of women helping other women succeed in research, with a special focus on enhancing diversity in biomedical science. The purpose of this site is to provide women in biomedical careers of diverse racial and ethnic backgrounds and their supporters with a venue for networking and sharing information. Members can exchange ideas about career development, get advice on navigating the NIH grants process, and participate in discussion groups on a wide range of topics, such as mentoring, science policy, and work-life balance.

The Women of Color (WOC) Committee of the NIH Working Group on Women in Biomedical Careers recognizes that women of color may face unique challenges to entering and advancing in biomedical careers. Some of these challenges have been well documented and described beginning with the historic 1975 paper by Shirley Malcom, et al. (Malcom, S. M., Hall, P. Q., & Brown, J. W. (1975) The double bind: The price of being a minority woman in science. Washington, DC: American Association for the Advancement of Science).

There are a number of online activities available through the WoCRn:

  • Complete a researcher Profile
  • Find colleagues using the Membership Directory
  • View Resources
  • Start a topic in the Forum
  • Connect with others with shared interests through a Group
  • Share entries from the Spectrum Blog with co-workers and mentees.

Participate in the online community that is addressing the challenges faced by all women and minorities entering and advancing in scientific careers. Join the NIH efforts for women of color and everyone who values diversity in the scientific workforce! Join the conversation and the network now!

SCORE Call For Posters Extended Until May 20th

Deadline_ExtensionThe 8th Annual Study Coordinators Organization for Research and Education (SCORE) Half-Day Seminar will take place at the University of Rochester School of Medicine & Dentistry on Tuesday, June 7th, in the Ryan Case Method Room 1-9576.

Call-for-Posters: SCORE invites study team members (study coordinators/project nurses) to submit posters by Friday, May 20th to be displayed at the 8th Annual SCORE Half-Day Seminar – For further information click here.

The seminar, Professional Development for Research Personnel, will be presented for those who actively coordinate health research. A light breakfast fare will be available. Event is presented by the Study Coordinators Organization for Research & Education (SCORE) and the University of Rochester School of Nursing, and sponsored by the Association of Clinical Research Professionals (ACRP) and the Clinical and Transnational Science Institute (CTSI). All attendees (nurses and non-nurses) have an opportunity to earn 3.83 continuing education contact hours.

For questions, please contact SCORE@urmc.rochester.edu .

To register on-line, click here by June 2nd. There is no charge for this event. There will be a $6 cost for parking in the MRB lot.

If you need special accommodations, for example ASL interpreters, please contact SCORE@urmc.rochester.edu by May 23, 2016, 12 noon. The University of Rochester Center for Nursing Professional Development is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.