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TRI Biomedical Informatics Pilot Awards

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 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

Applications Sought for CTSA Inter-institutional Pilot Awards

The Western States Consortium, which includes the UAMS Translational Research Institute (TRI) and four other Clinical and Translational Science Award (CTSA) institutions, has issued the call 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, University of Kansas Medical Center, and University of Utah, all part of the national CTSA consortium, supported by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). (Note: The University of Kansas Medical Center is not participating in 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.

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

Applications are due Jan. 19, 2018, at 5 p.m. (CT). Please submit to NLIndelicato@uams.edu.

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

Key Dates:

  • IRB Submission Deadline: Nov. 24, 2017
  • Application Deadline: Jan. 19, 2018, 5:00 pm Central Time
  • Notice of intent to fund at each CTSA: Feb. 2, 2018
  • Just In Time Period: Feb. 2, 2018 – Feb. 9, 2018
  • Submission to NIH for Prior Approval of Human Subjects: Feb. 12, 2018
  • Funding Cycle: April 1, 2018 through March 31, 2019

Download Request for Applications

TRI Part of NIH Milestone to Accelerate Multisite Clinical Studies

CTSA Program paves way for nationwide single IRB model.

Developing new treatments for diseases often requires large numbers of clinical research participants enrolled in the same study at numerous geographical sites. These multisite clinical trials are well-positioned to discover whether a promising therapeutic is safe and effective, and may provide medical professionals with the information needed for treating their patients. However, the initiation of such studies may be delayed because each site typically relies on its own Institutional Review Boards (IRBs) to provide ethics reviews of the risks and benefits of the proposed research.

Christopher P. Austin, M.D.

The National Institutes of Health (NIH) is leading policy and programmatic initiatives to streamline this overly cumbersome process. NIH’s National Center for Advancing Translational Sciences (NCATS) announced today that all Clinical and Translational Science Awards (CTSA) Program sites (including the UAMS Translational Research Institute) have signed on to the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB authorization agreement. This agreement — which now includes a total of more than 150 top medical research institutions — will enable all participating study sites to rely on the ethics review of one IRB for each study, making it possible to initiate multisite studies within weeks instead of months. For patients waiting to enroll in a study, this could make a life-saving difference.

The SMART IRB authorization agreement serves as a model to help investigators adhere to the NIH’s policy on single IRB use for multisite studies. This policy was designed to improve IRB efficiencies while ensuring the protection of research participants so that research can proceed expeditiously.

The authorization agreement effort was led by Harvard Catalyst, University of Wisconsin-Madison Institute for Clinical and Translational Research, and Dartmouth Synergy. Through these institutions, a team of NCATS-supported SMART IRB ambassadors facilitated and provided critical guidance and support to assist institutions in joining and implementing the SMART IRB authorization agreement.

“This milestone is a giant step toward a nationwide model for greater efficiency in IRB review, which is critical to getting more treatments to more patients more quickly,” said NCATS Director Christopher P. Austin, M.D. “It was made possible by the teamwork of hundreds of experts across the country who worked together to achieve what was thought to be impossible even a few years ago.”

In addition, the SMART IRB authorization agreement will provide the foundation for NCATS’ Trial Innovation Network central IRBs. The Trial Innovation Network is a collaborative CTSA Program initiative designed to address critical roadblocks in clinical research, and to optimize and streamline the clinical trial and studies process.

Next steps for the NCATS SMART IRB Platform include the development of education, training and harmonization of best practices for a single IRB review. Learn more at https://ncats.nih.gov/expertise/clinical/smartirb and https://smartirb.org (link is external).

About the National Center for Advancing Translational Sciences (NCATS): To get more treatments to more patients more quickly, NCATS incorporates the power of data, new technologies and strategic collaborations to develop, demonstrate and disseminate innovations in translational science. Rather than targeting a particular disease or fundamental science, NCATS focuses on what is common across all diseases and the translational process. Learn more at https://ncats.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

‘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

New Tool Simplifies and Expands Cohort Searches

Amy Jo Jenkins, M.S., and Ahmad Baghal, M.D.

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.

<a href=”https://urldefense.proofpoint.com/v2/url?u=https-3A__t.e2ma.net_click_cimvkb_cun0ym_4rsw6r&d=DwMFaQ&c=27AKQ-AFTMvLXtgZ7shZqsfSXu-Fwzpqk4BoASshREk&r=4LXLFJs5XBtylClwIS_UAgK8uCNIrvwWz1icOu8671Y&m=bKx0sJm3z5KdF-B_iFTQ4iZmbERtwj3sACetCQVvfLQ&s=vjgjhCpVv2Ih9CauGwHKTXeU9zptd0cTHm8GUqa4p6c&e=”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.

Download: Health Science Entrepreneurship flier

Researchers Urged to Complete GCP Training

The NIH Policy on Good Clinical Practice (GCP) Training became effective January 1, 2017. This policy applies to NIH-funded investigators and site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials. An NIH Clinical Trial is defined as Research studies in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.  An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.

If you are conducting an NIH-funded clinical trial, you will need to complete your training as soon as possible. There are several ways to do this: 

  1. Complete GCP training using the CITI program at https://www.citiprogram.org/. Log in using the user ID and password that you used for your human subjects protection training, scroll down past the list of courses you have completed and select Add a Course. Select Good Clinical Practice (GCP) Basic Course.
  2. Complete NIH-developed GCP training. Send completion certificate to Catrice Banks-Johnson in the Office of Research Compliance (CRBanksjohnson@uams.edu). 
  3. For social and behavioral researchers, you can log onto Blackboard and complete the NCATS-developed GCP training.  View documents for the GoSignMeUp registration process and basic navigation functions for the Blackboard Course. A Certification of Completion will be generated upon the conclusion of the final module.  Send completion certificate to Catrice Banks-Johnson in the Office of Research Compliance (CRBanksjohnson@uams.edu).
  4. Send record/certificate of current GCP training (i.e., from industry-sponsored trial participation, from ACRP or SoCRA certification, or from completion of UAMS Graduate School courses PHSC6043 or PGSP6101) to Catrice Banks-Johnson (CRBanksjohnson@uams.edu). 

For options 2-4 above, Catrice will record this training in Training Tracker for you upon receipt of your completion certificate.  

NOTE: GCP training expires after three years.

If you have ambitions of conducting an NIH-funded clinical trial, you are highly encouraged to complete the training now!  

Even if you have determined this does not apply to you, you are highly encouraged to complete the training now!  GCP training is likely to be mandated within the next 6-12 months, as many institutions, journals, and other funding sources are trending toward this requirement.

The UAMS Office of Research Compliance will conduct random audits to ensure compliance with this policy.

If you have any questions, please contact one of the following institutional offices:

Amy Jo Jenkins
TRI
686-5939
ajjenkins@uams.edu

Jennifer Holland
IRB
526-7559
jrholland@uams.edu

Darri Scalzo
Office of Research Compliance
686-8062
dlscalzo@uams.edu

Larry Cornett, Ph.D.
Office of the Vice Chancellor for Research
686-5347
cornettlawrencee@uams.edu