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Short Course on Analysis of Incomplete Data, April 28

Ofer Harel, Ph.D.

The Central Arkansas Chapter of the American Statistical Association (CASA) is sponsoring a one-day short course about the Analysis of Incomplete Data on Friday, April 28, 2017, from 9 a.m. – 4:30 p.m. in the College of Public Health building, room 8240.

Biased results and inefficient estimates are just some of the risks of incorrectly dealing with incomplete data, a common problem in applied research. This course will emphasize practical implementation of proposed strategies for dealing with missing data, including discussion of software to implement recommended procedures.

The instructor is Ofer Harel, Ph.D., professor of statistics at the University of Connecticut. Harel received his doctorate in statistics in 2003 from the Pennsylvania State University and post-doctoral training in biostatistics at the University of Washington. He has served as a biostatistical consultant nationally and internationally since 1997 and has been involved with a variety of research fields including Alzheimer’s, diabetes, nutrition, HIV/AIDS, and alcohol and drug abuse prevention.

The cost to attend the short course is $90 for CASA members, $100 for non-members, and $35 for full time students. Lunch is included in the registration fee.  See printable registration form. 

The registration fee may be paid by check with a check payable to Central Arkansas Statistical Association, credit card (send an email to James Selig jpselig@uams.edu with the completed registration form and you will receive an invoice through PayPal that can be paid with a credit card), or by IDT (email the completed registration form to jpselig@uams.edu with a note that you will be paying by IDT to Account #: 117-1003693, GL Code: 631400 and include the account to be charged).

‘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.  

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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. 

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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

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.

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