February 7, 2020
Clint Kilts, Ph.D.
Uncategorized
UAMS Offering Research Leadership Training to Community-Based Organizations
Community-based organizations are invited to apply for a new research leadership training program at the University of Arkansas for Medical Sciences (UAMS) that includes seed funding for community projects.
Applications are due by Oct. 14, 2019, for the Community Partners Educated as Arkansas Research Leaders (CPEARL) Program, supported by the UAMS Translational Research Institute.
Up to six community-based organizations will be selected, with two or three leaders or emerging leaders per organization invited to participate. Up to $2,500 in seed funding will be provided to each organization to tackle a health-related community project.
The one-year program will begin Jan. 15, 2020, with a six-week intensive training offered by the Translational Research Institute in partnership with the Arkansas Department of Health.
“UAMS research can play a bigger role in improving health, especially if we can engage communities most burdened by poor health in influencing our research,” said Kate Stewart, M.D., M.P.H., director of the research institute’s Community Engagement Program. “We will use this new program to build capacity of community leaders and empower them with the knowledge to partner in research addressing our state’s health disparities.”
Experts in community-based research, clinical and public health practice and community engagement will provide interactive learning sessions during the six-week intensive training. Each team will have a UAMS researcher assigned to mentor them throughout the year and the opportunity for one-on-one consultations with a community mentor. The program is free and all trainings will be held in Little Rock.
Interested community-based organizations may contact
Funding for the project is supported by the Translational Research Institute, Clinical and Translational Science Award UL1 TR003107, through the National Center for Advancing Translational Sciences at the National Institutes of Health.
For more information, visit the CPEARL Program Page.
Applications may be submitted to triceteam@uams.edu.
Questions? Contact RBHale@uams.edu.
November/December TRIbune
The Translational Research Institute (TRI) is wrapping up 2017 with good tidings!
The November/December TRIbune features some helpful new developments with clinical trials: Trails Today, a CTSA initiative that makes it easier for the public to find clinical trials of interest; TriNetX, which is matching UAMS investigators with industry sponsored Clinical Trials; and ClinCard, a new more efficient way of compensating research participants. You’ll also read about our latest pilot awardees – the first time we’ve offered pilots in implementation science. Our TRI & Me features Geoffrey Curran, Ph.D., who leads TRI’s implementation science efforts and directs the UAMS’ Center for Implementation Research. You’ll also find the latest TRI-supported publications cited by your colleagues.
TRI Names Four New KL2 Scholars
Four early career UAMS researchers were recently selected to receive KL2 Mentored Research Career Development Scholar Awards.
The KL2 Scholar program provides two years of research training to junior faculty. It provides 75 percent salary support and up to $25,000 per year for research, tuition, travel and education. The scholars, all from the UAMS College of Medicine, are:
- Lisa Brents, Ph.D., instructor, Department of Phamacology and Toxicology.
Her research is focused on improving buprenorphine treatment of opioid use disorder during pregnancy by reducing fetal exposure to an active metabolite of buprenorphine, norbuprenorphine.
KL2 project title: The Metabolic and Pharmacodynamic Profile of Deuterated Buprenorphine
- Sufna John, Ph.D., assistant professor, Department of Psychiatry.
Her research is examining the impact of early childhood education factors on the effectiveness of therapy services for preschool-aged children who present with disruptive behaviors.
KL2 project title: Improving Outcomes for Young Children with Behavior Disorders: A Coordinated Care Model
- Rosemary Nabaweesi, Dr.P.H., M.B.Ch.B., M.P.H., assistant professor, Department of Pediatrics, Center for Applied Research and Evaluation (CARE).
Her research is focused on injury-related infant mortality prevention and reduction of health disparities for rural and underserved populations.
KL2 project title: Developing Safe Sleep Interventions for Rural Underserved Communities
- Carolina Schinke, M.D., assistant professor, Department of Internal Medicine, Myeloma Institute.
Her research is attempting to determine yet undiscovered pathologic pathways in multiple myeloma and to identify new therapeutic targets.
KL2 project title: The Role of Pl-IF 19 as a Promoter of Tumorigenicity and Therapeutic Target in Multiple Myeloma
Fifteen KL2 Scholar applications were reviewed by a study section (committee) made up of faculty members from UAMS and other research institutions. Five finalists were interviewed by senior members of the panel.
This year’s awards are supported by UAMS institutional funds provided to TRI, and funding from Arkansas Children’s Research Institute and the UAMS Psychiatric Research Institute.
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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:
- 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.
- Complete NIH-developed GCP training. Send completion certificate to Catrice Banks-Johnson in the Office of Research Compliance (CRBanksjohnson@uams.edu).
- 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).
- 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
