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The TRIbune is Here!

TRI’s March-April newsletter, The TRIbune, features a breakthrough success in research collaboration with the adoption of SMART IRB by all the CTSA sites across the country, including UAMS. This new single IRB capability is expected to spur inter-institutional collaborations for multisite clinical trials and help avoid trial delays. We also note the numerous cross-CTSA collaborations that involve UAMS researchers and TRI.  Along those lines, we highlight a recent retreat on data available to researchers through the Arkansas Center for Health Improvement. The retreat was enlightening for research leaders from UAMS, Arkansas Children’s Research Institute and the Central Arkansas Veterans Healthcare System. Our TRI & Me feature spotlights Donald Mock, M.D., Ph.D., who leads our Pilot Studies Program, and you can view the latest TRI-cited publications.

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Newsletter Archive

TRI Awards Four Pilot Research Studies

Kristie Hadden
Kristie Hadden
Atul Kothari
Atul Kothari
Se-Ran Jun
Se-Ran Jun
Bradley Martin
Bradley Martin

The UAMS Translational Research Institute (TRI) has approved four research pilot study awards totaling about $166,000.
Nine applicants sought awards of up to $50,000 for one-year projects that utilized translational biomedical informatics approaches to improve health and solve health care issues of rural and underserved populations.
The 2017 pilot awardees and their project titles are:

  • Kristie Hadden, Ph.D., assistant professor, College of Medicine, Division of Medical Humanities, “Patient health literacy screening: An informatics approach.”
  • Se-Ran Jun, Ph.D., assistant professor, College of Medicine, Department of Biomedical Informatics, “Genomic surveillance of mumps outbreak in Arkansas using third generation sequencing technology.”
  • Atul Kothari, M.D., assistant professor, College of Medicine, Department of Internal Medicine, “Molecular epidemiology and transmission of Clostridium difficile infections (CDI) in nosocomial settings.”
  • Bradley Martin, Ph.D., Pharm.D., professor, College of Pharmacy, “Development, validation, and implementation of an opioid risk prediction tool.”

“The purpose of our pilot awards is to help researchers develop novel technologies and methods and to test the feasibility of their approaches,” said Laura James, M.D., TRI director and associate vice chancellor for clinical and translational research. “This year’s focus on collaborations with experts in biomedical informatics will test state-of-the-art solutions to problems common in Arkansas. Each project also has high potential for extramural funding and for application to individuals beyond Arkansas.”

Applications were reviewed and scored by a study section of 23 faculty and community representatives. The study section, led by Donald Mock, M.D., Ph.D., included independent scientists from a wide range of disciplines and from across the country, and community stakeholders from across Arkansas. Inclusion of trained community stakeholders is a novel venture for this pilot program that helps realize the NIH goal of ensuring that studies have the input of the general public, clinicians and professionals in the health industry. This year was the first time that community stakeholders participated in the full review, discussion, and scoring process.

CTSA Consortium Issues Call for Inter-Institutional Pilot Award Applications

The Western States Consortium, which includes the UAMS Translational Research Institute (TRI) and three other Clinical and Translational Science Award (CTSA) institutions, issued the call April 3 to all faculty for pilot award applications.

In addition to TRI, the Western States Consortium members are the University of Kentucky, University of New Mexico and University of Utah, all part of the national CTSA consortium, supported by the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS). (Note: The University of Kansas Medical Center has withdrawn from this pilot program.)

The purpose of the pilot awards is to promote inter‐institutional collaboration by funding innovative, translational research projects that involve two or more of the four Western States Consortium members.

Awards of up to $25,000 will be provided by each participating institution. The total funding available for a particular collaborative project will depend on the number of participating institutions and the level of funding that each institution devotes to the program.

The cover page and letter of intent are due by noon, April 24, 2017, at TRIservices@uams.edu. The application deadline is 5 p.m., July 1, 2017. The funding cycle is from Nov. 1, 2017, to Oct. 31, 2018.

For additional details, view the Request for Applications (RFA) document and the letter of intent form and guidelines. If you have any questions, please contact Nia Indelicato at NLIndelicato@uams.edu or 501-614-2287.

The 2017 inter-institutional RFA is the fourth pilot funding opportunity by the Western States Consortium.

 

Download Request for Applications

 

Download Letter of Intent

K Awards Informational Session Recording, Slides Available

Mary Aitken, M.D., Joshua Kennedy, M.D., and Taren Swindle, Ph.D., were part of a panel discussion Thursday on NIH K awards. Kennedy and Swindle are recent K award recipients, and they shared their experiences leading to their successful applications.

Download SlidesPlay Video

‘Budgeting for Grant Applications’ March 24

Renee Raines, CCRP, CRA, director of the Office of Sponsored Programs Administrative Network (OSPAN), will present “Budgeting for Grant Applications” on March 24, 8:30 – 10 a.m., at the Psychiatric Research Institute, room 136.

Her presentation, part of the TRI Research and Career Development Seminar Series, will include information on OSPAN’s services provided to researchers.

Please register via TrainingTracker. The presentation is also available via BlackBoard Collaborate.  

Download Flyer

Visiting Latino Leader, Scholar to Give Three Lectures March 16, 17

UCLA Distinguished Professor of Medicine David E. Hayes-Bautista, Ph.D., who has spent decades studying and writing about the links between culture, behavior and health, will give three presentations in Little Rock on March 16 and 17.

The UAMS Translational Research Institute is sponsoring a reception following his March 16 presentation, “Latino Leadership and the Cinco de Mayo in the American West,” from 6-7 p.m., at the Clinton School of Public Service, Sturgis Hall, 1200 President Clinton Ave. 

View Flier

Hayes-Bautista is director of the Center for the Study of Latino Health and Culture at the UCLA David Geffen School of Medicine. For the past five years, he has been chosen one of the 101 Top Leaders of the Latino Community in the U.S. by Latino Leaders Magazine. In 2012, he received the Association of American Medical Colleges (AAMC) Herbert W. Nickens Award for his lifelong concerns about the educational, societal, and health care needs of underrepresented groups.

For more than three decades he has studied the “Latino Epidemiological Paradox,” the tendency of Latino Americans to have health outcomes comparable to or better than their non-Hispanic white counterparts in the U.S., and the implications of this paradox for populations, chronic diseases and communicable diseases. 

To join the March 16 lecture at ACH via live streaming on your PC, MAC, iPad or iPhone:

  1. Visit www.archildrens.org/video
  2. Click on the Peds PLACE icon
  3. Click on the topic and date listed above (or search)
  4. If watching LIVE, remember that you can send in questions for the speaker

New Tool Simplifies and Expands Cohort Searches

Tools should make life easier, and that applies to the tools researchers use accessing the Arkansas clinical Data Repository (AR-CDR), formerly the UAMS Enterprise Data Warehouse.

The AR-CDR has been a pillar of UAMS’ translational research infrastructure since its establishment in 2011 with support from the Translational Research Institute (TRI).

In 2015, UAMS leadership made improving researcher access to the AR-CDR a priority with the creation of the AR-CDR work group, led by Charlotte Hobbs, M.D., Ph.D., executive associate dean for research in the College of Medicine. The work group also included representatives from UAMS Information Technology, TRI, and the Department of Biomedical Informatics.

TRI, through its Clinical and Translational Science Award (CTSA) Consortium activities, discovered TriNetX, a federated clinical data network of providers, including pharmaceutical companies and contract research organizations (CROs), as well as 21 CTSA institutions. TriNetX presented to the work group, and TRI Director Laura James, M.D., and TRI Executive Program Manager Amy Jo Jenkins, M.S., led the effort to make UAMS part of the federated network, integrating it with the AR-CDR.

Jenkins organized an onboarding team of 16 people from TRI, the Department of Biomedical Informatics and UAMS Information Technology for acquiring and installing the network’s cohort estimation tool, establishing a security protocol, and training. “The work of our interdepartmental team was phenomenal,” Jenkins said. “UAMS had the fastest onboarding in the network’s history.”

The collaboration began in September, providing all UAMS researchers with three significant benefits:

  • It includes a user-friendly search tool for exploring the rich clinical data repository as a preliminary step in developing clinical research studies.
  • It helps match investigators with industry sponsored clinical trials.
  • It can link cohort data at multiple network sites in the future.

Another key change recommended by the work group is the addition of the AR-CDR’s first director, Ahmad Baghal, M.D., who joined UAMS in October.

Baghal predicts the new search engine, the UAMS Research Cohort Estimation Tool, will be popular with researchers.

“We now have an intuitive cohort estimation tool; anybody can learn to use it in 10 minutes,” he said.

Apples to Apples

The primary tool for research cohort identification has been i2b2 (Integrating Biology and the Bedside). While it remains a component of AR-CDR, it has moved to the background with the UAMS Research Cohort Estimation Tool offering a self-service capability that provides researchers with deidentified aggregates for a study cohort.

“A nice feature of the new cohort estimation tool is the future ability to expand a study cohort by including other collaborating institutions in a query search. The good thing about the tool is that data received from different institutions are mapped to a single, unified ontology,” Baghal said.

Trial Run

Brad Martin, Ph.D., Pharm.D., gave the new system a trial run and came away impressed.

“Comparing the new query tool to the previous platform, i2b2, is kind of like comparing Windows to DOS,” said Martin, a professor in the UAMS College of Pharmacy. “The cohort estimation tool allows for an intuitive approach to understanding patterns in the data warehouse. One of the most impressive features of the new platform is that it allows users to build temporality into the queries. For example, users can build queries that require a diagnosis before some drug exposure or vice versa, which is critical for research and quality improvement analyses.”

The information researchers gather from their cohort estimation queries will help them determine whether to pursue additional, identifying data elements (e.g., demographics, procedures and diagnoses). To receive the identifiable data, researchers must seek IRB approval and submit a data request using the Request Services portal button on the TRI website (tri.uams.edu).

Additional information is also on the TRI website, including an online training tutorial. The Arkansas Clinical Data Repository (AR-CDR) page is in the main menu under Services, or simply type AR-CDR in the search field to find it.

In addition, Baghal will meet with research groups for more specialized training.

New Clinical Trial Opportunities

Another powerful feature of UAMS’ membership in the federated network is the abundance of new prospects for UAMS participation in industry sponsored clinical trials. The network serves as a matchmaker, helping the pharmaceutical industry identify researchers to conduct clinical trials.

“As members of the network, there are mutually beneficial opportunities for our researchers and the pharmaceutical industry looking for collaborators,” James said.

Jenkins has served as the liaison to industry sponsors looking for sites to run their clinical trials. After receiving an inquiry, she attempts to find an interested investigator through the UAMS Service Line research liaisons or the Rockefeller Cancer Institute. She facilitates the required confidentiality agreements and works with the sponsor to get their trial placed at UAMS.

Since becoming part of the network, UAMS has received 22 inquiries about clinical trial opportunities. UAMS faculty are pursuing clinical trials in stem cell transplantation, cytomegalovirus infection, pain management, irritable bowel disease, renal disease, diabetes and prostate cancer.

“The network collaboration is helping UAMS faculty be at the front end of clinical trial opportunities as trials are being rolled out from pharmaceutical sponsors,” James said. “It increases our visibility to the broader research industry, and that’s good for UAMS and our patients.”

April 12 Webinar: Learn How to Conduct Multisite Clinical Trials with a Single IRB

The first SMART IRB webinar on April 12, 3:30 – 4:30 p.m., will provide an overview of the SMART IRB Online Reliance System, which will be available to researchers later this spring. UAMS is among the Clinical and Translational Science Award (CTSA) Consortium SMART IRB participating institutions.

The Online Reliance System is a unique tool that helps institutions establish and document single IRB review arrangements. By using this system:

  • Investigators can create and submit requests to use a single IRB for their studies.
  • Collaborating institutions can work together to identify a Reviewing IRB and track and document reliance arrangements on a study-by-study basis.
  • Users have a clear understanding of next steps and are notified when action is required.

The webinar will be led by Nichelle Cobb, Ph.D., chief regulatory operations officer for Implementation for SMART IRB, and director of the Health Sciences IRBs Office at the University of Wisconsin-Madison.

Register for Webinar

 

TRI Changes Process for Study Budget Development & Negotiations

The Translational Research Institute (TRI) Clinical Trials Innovation Unit (CTIU) recently revised the process for investigators submitting studies that require a Medicare coverage analysis and budget in CLARA.  

In addition to conducting full Medicare Coverage Analysis, CTIU’s Research Finance Team (RFT) offers full budget development and/or negotiation services for all non-cancer-related protocols requiring a budget. To access all services, the investigator or designee submits a request through the TRI services portal. RFT members will work with investigators and their team to complete the budget, coverage and legal process in an efficient manner.

To increase efficiency and provide feasibility data to investigators, the RFT has altered the order of its coverage and budget activities, performing the Medicare Coverage Analysis prior to budget development and review. If investigators and their team wish to develop and/or negotiate the budget themselves, the RFT highly encourages them to submit the required study documents to the RFT prior to starting budget development. The RFT will provide a Medicare Coverage Analysis Report (MCAR) that is sent to the investigator for approval and can be used as a guide for budget development. 

It is not mandatory to obtain a MCAR prior to budget development. However, if the budget is developed prior to the MCAR it will likely delay the budget approval process for the study. If investigators or study teams have questions about this process, contact Jonathan Young, JAYoung@uams.edu, 526-7984.

UAB Entrepreneur to Speak at HSE Seminar, March 1

The next Health Sciences Entrepreneurship Seminar will feature Erik Schwiebert, Ph.D., from the University of Alabama, Birmingham (UAB), speaking March 1, from 5 – 6 p.m. at the Reynolds Institute on Aging, Jo Ellen Ford Auditorium. 

Schwiebert will present “New Paradigms for Scientist to CEO Transition and New Biotechnology Startup Creation.”

DiscoveryBioMed, Inc. is a Birmingham-based life sciences and biotechnology company, with the goal of integrating human cell physiology with the drug discovery critical path. Schwiebert, a physiologist, launched the company in October 2007. Since then DiscoveryBioMed has continued to grow and gain recognition both locally and nationally.

The UAMS Seminar Series is being offered in collaboration with UAB, University of Kansas Medical Center and the University of Utah – all Clinical and Translational Science Award (CTSA) institutions. The series is sponsored by the NIGMS Systems Pharmacology and Toxicology T32 Training Program, UAMS Translational Research Institute (TRI) and UAMS BioVentures.

If you missed last month’s seminar featuring UAMS’ Amy Hester, Ph.D., watch it here