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TRI Names Four New KL2 Scholars

Four early career researchers were recently selected to receive KL2 Mentored Research Career Development Scholar Awards.

Fifteen KL2 Scholar applications were reviewed by a Study Section and finalists were interviewed by senior members of the panel. The scholars, all from the College of Medicine, are:

Lisa Brents
Lisa BrentsPh.D., instructor, Department of Phamacology and Toxicology
KL2 project: The Metabolic and Pharmacodynamic Profile of Deuterated Buprenorphine
Sufna John
Sufna JohnPh.D., assistant professor, Department of Psychiatry/Psychology
KL2 project: Improving Outcomes for Young Children with Behavior Disorders: A Coordinated Care Model
Rosemary Nabaweesi
Rosemary NabaweesiDr.P.H., M.B.Ch.B., M.P.H., assistant professor, Department of Pediatrics,Center for Applied Research and Evaluation CARE
KL2 project: Developing Safe Sleep Interventions for Rural Underserved Communities
Carolina Schinke
Carolina SchinkeM.D., assistant professor, Department of Internal Medicine, Myeloma Institute
KL2 project: The Role of Pl-IF 19 as a Promoter of Tumorigenicity and Therapeutic Target in Multiple Myeloma

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.”

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

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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

TRI Research and Career Development Seminar Slides Available

Slides are now available from Susan Steelman, MLIS, UAMS head of education and reference services, who was the Feb. 22 speaker for the TRI Research and Career Development Seminar Series.

Download: Library 301: Publishing Pitfalls & Resources for Researchers/Authors

The TRIbune Is Here!

The January-February TRIbune newsletter is here! This issue features some exciting developments in Big Data accessibility for UAMS researchers. We now offer researchers a new cohort tool and access to a larger data network. You’ll also read about Amhad Baghal, M.D., our first director of the Arkansas Clinical Data Repository (AR-CDR), formerly the UAMS Enterprise Data Warehouse. Baghal, who arrived in October, is continuing to build on the new opportunities now available, so stay tuned! TRI’s Beatrice Boateng, Ph.D., director of evaluation and continuous improvement, is the subject of our TRI & Me feature, and we include your TRI-cited publications.

Download PDF

Newsletter Archive

Cancer Institute’s Kacie Simpson Honored for Work with Research Participants

Kacie Simpson (right) received the Bonny Hope Wallace Award from Sandy Annis.

Kacie Simpson (right) received the Bonny Hope Wallace Award from Sandy Annis, a past recipient.

Kacie L. Simpson, the clinical research associate team lead at the UAMS Winthrop P. Rockefeller Cancer Institute, is the 2016 Bonny Hope Wallace Award recipient for her outstanding work with research participants.

The award was presented by Sandy Annis, a past recipient of the award who directs the UAMS Cancer Clinical Trials Office, at a Jan. 27 ceremony. Simpson was chosen for the award by members of the UAMS Certified Research Specialist Program.

Simpson has been at the Cancer Institute for 10 years. For the last nine years she has worked with patients in cancer clinical trials. She has served many roles in the Cancer Clinical Trials and Regulatory Affairs offices, including regulatory specialist, study coordinator, and for the last four years, manager of the study coordinators.

“It was an honor to be nominated for the Bonny Hope Wallace Award and selected by my peers to receive the award,” Simpson said. “I am also honored to work with world class physicians, nurses, research staff, and most importantly, the people who participate in research at the Cancer Institute.”

Simpson is a member of the Society of Clinical Research Associates (SoCRA), Association of American Cancer Institutes (AACI), the SWOG Oncology Research Professional (ORP) Liaison Committee, and the study coordinator for the SWOG Melanoma Committee. She has had UAMS Certified Research Specialist (CRS) certification since 2008 and SoCRA Certified Clinical Research Professional (CCRP) certification since 2010.

Wallace is remembered for her respectful treatment of research participants and her commitment to research integrity. She worked in research at UAMS for more than 30 years before her death in 2004.

Recipients of the award in Wallace’s name must demonstrate dedication to the research participant; respect for the participant’s sacrifice; devotion to research integrity; commitment to mentoring; and enthusiasm for learning.

Wallace was an instructor in surgery and laboratory director for surgical research at the Department of Surgery at UAMS as well as clinical coordinator of research at the Arkansas Children’s Hospital Burn Unit. Her efforts were focused on cutting-edge research to promote women’s health. Her accomplishments were many and her awards of recognition are numerous.

UAMS’ Data Sluice Machine

Biomedical informatics initiatives at UAMS cover the spectrum in the clinical and translational cycle for improving human health.

Biomedical informatics initiatives at UAMS cover the spectrum in the clinical and translational cycle for improving human health.

If new biomedical discoveries are like gold, to borrow the metaphor used by Meredith Zozus, Ph.D., the prospecting days are fast coming to an end. A new associate professor in the rapidly expanding Department of Biomedical Informatics (DBMI), Zozus was explaining UAMS’ recent and forthcoming biomedical informatics strategies to benefit clinicians, biomedical researchers and graduate students.

The need for managing enormous amounts of data and meeting the NIH’s new, higher expectations for rigor and study reproducibility are helping drive UAMS’ efforts for more robust data management systems. Another factor is the increasing difficulty compared to 20 years ago for a clinical researcher to make a single discovery that improves health outcomes, Zozus said.

“Back then, finding those gold nuggets was a lot easier. You could do a large study and learn something new that changed clinical practice and improved outcomes,” she said. “But those gold nuggets have become harder to find. So, like real-life prospectors, we’re moving from panning for gold to computationally sifting through tons of data to find the nuggets.”

Zozus also noted that the NIH, through its Big Data to Knowledge (BD2K) initiative, is targeting a growing shortage in biomedical research of individuals with computational expertise, informatics and statistics, with enough understanding of the underlying biology, biochemistry or physiology to really collaborate with a biomedical scientist. The challenge is particularly acute for extremely large datasets, where different methods are needed.

To help ensure UAMS is a leader in biomedical informatics, Fred Prior, Ph.D., who chairs DBMI and leads TRI’s Comprehensive Informatics Resource Center, recently announced new – some nationally unique – education initiatives to the TRI Leadership Council. Together the initiatives cover the translational spectrum, from molecules to populations. Pending approval from the Arkansas Department of Higher Education (ADHE), and starting in fall 2017, these four tracks in different areas of Biomedical Informatics will offer certificates, master’s degrees and doctorates:

Translational Bioinformatics. This degree program is for researchers using data in cellular and molecular level studies that have a clinical target, e.g., a study of genes producing a protein that has a role in disease. The field also encompasses work with pre-clinical data as development and testing begins for new targets, compounds or devices.

Imaging Informatics. Training in Imaging Informatics, offered only a few places nationally, includes coursework in research imaging to teach the latest modalities and methods of managing and interpreting images used in research. It also includes coursework for imaging professionals, i.e., those who run a hospital’s picture, archiving and communication (PAC) system where images such as CT scans, X-rays, and MRIs are stored.

Clinical Informatics. This program is for those interested in generation, management and use of information in health care settings, i.e., clinical decision support or algorithms to predict patients who are likely to respond well to treatment. Clinical informatics is a medical subspecialty approved in 2011 by the American Board of Medical Specialties. DBMI ran its first review course this summer to help physicians sitting for the clinical informatics board exam. The review class will be offered again this summer as a free service to all physicians in Arkansas who want to sit for the exam. Other plans include a fellowship in clinical informatics.

Clinical Research Informatics. If approved by ADHE, UAMS may be the first program to offer graduate degrees in Clinical Research Informatics in the United States.

Clinical research informatics involves data for the design, conduct and reporting of clinical studies. While easily confused with clinical informatics, clinical research informatics is not research on clinical informatics; instead, it is the informatics of research, i.e., how information is used in gauging the feasibility, or in designing, conducting or reporting clinical studies. If approved by ADHE this spring, the Clinical Research Informatics track will include a master’s degree and Ph.D. as well as a professional master’s option.

All four tracks will have the option of distance learning.

DBMI and TRI will also continue the Research & Application Seminar Series, which is open to the public and offers an hour of CME credit to clinical and informatics professionals across the state for attending seminars on the latest biomedical research tools and practices.

While biomedical informatics is not new to UAMS, it is increasingly approaching the data as a science, considering its fundamental properties and how those should govern its management, Zozus said.

“As an institution we are increasingly providing collaboration, informatics expertise and data infrastructure to biomedical researchers at all scales, from the smallest to the largest of studies, so our investigators don’t have to build their own data processes,” she said. “In essence, we are building a data sluice operation.”