Upcoming CCTS Events
The final CCTS Forum for 2016 provided an overview of the exciting opportunities on the horizon for clinical researchers in 2017, which can be summarized by one acronym: “i2b2.” The UAB instance of i2b2, which stands for “Informatics for Integrating Biology & the Bedside,” said UAB Informatics Institute (II) Director Dr. James J. Cimino, provides researchers with access to de-identified EHR data derived from the Cerner Impact system.
“i2b2 is a great way to explore hypotheses and check study feasibility prior to writing a grant,” said UAB Informatics Institute (II) Assistant Director Matthew Wyatt. “It offers a more user-friendly interface to conduct self-service queries than the Enterprise Data Warehouse, and also allows researchers to obtain HIPAA limited data sets or request a consultation by just dragging and dropping their data set into a field and asking for help.”
Wyatt shared numerous case studies highlighting innovative ways researchers are already using i2b2, including assessing recruitment potential, exploring patient populations, and even developing software. He also reviewed several innovative features the II has developed for UAB i2b2, including a data download plugin, integration with the UAB Learning Management System, IRB Exemption for Self Service access to patient level detailed data (HIPAA LDS), and others.
Wyatt also encouraged attendees to think beyond UAB for cohort estimation and recruitment. “If you don’t find the patients you need in the UAB EHR, you can use i2b2 to access data at other institutions via the Shared Health Research Informatics Network (SHRINE).” SHRINE is built on top of an i2b2 platform, setting the stage for multisite collaborations. Participating SHRINE institutions include UAB, the Medical University of South Carolina, the University of Kentucky, Emory, and the University of Arkansas Medical School, “and the list is growing.” Several CCTS Partners are also active in SHRINE instances, further extending the list of possible collaborators for multisite studies.
Leveraging our i2b2 instances, UAB is in partnership with a company called TriNetX, which connects potential trial sites and principal investigators to pharma sponsors supporting clinical trials on the basis of informatics-enabled assessment of cohort feasibility. TriNetX Chief Medical Officer Dr. Manfred Stapff spoke next, reviewing the advantages of a federated research network approach such as TriNetX. In addition to cohort queries, this network is similar to SHRINE in its ability to support multisite collaborations. “TriNetX also enables faster recruitment of prequalified patients and can help institutions win more competitive grants,” Stapff said, highlighting two additional benefits. Stapff provided a demonstration of the TriNetX user interface, showing how a researcher could apply a variety of exclusion/inclusion criteria and “easily determine possible enrollment hurdles.”
Attendees asked which data types researchers might expect to find in the three systems. All three will offer demographic patient data, as well as diagnosis, labs, and medications, but only i2b2 currently provides extended demographics on pregnancy, marital, and smoking status; alcohol consumption; zip codes, and living will. UAB’s i2b2 also includes data on allergies, immunizations, length of stay, lab panels, and is the only system to offer cancer registry data and the ability to provide project-specific data such as microbiology testing and rheumatology scores. There are plans to include genomic data in both i2b2 and TriNetX, and visit information in i2b2 and SHRINE, with i2b2 offering more extensive data on admit source, length of stay, and discharge disposition.
Researchers interested in learning more about how to use i2b2 are encouraged to sign up for a hands-on training session (the next available session is Thursday, Jan. 5, registration is required). Starting in 2017, the i2b2 training session will be offered bimonthly (visit the CCTS Events page for more information). For those interested in multisite collaborations or industry sponsored trials, contact CCTS Research Commons at
The CCTS is deeply grateful to the faculty members who serve as mentors in our TL1 program.
CCTS TL1 Trainee Poster Presenters (and their mentors)
Macie Enman presented Key Determinants for Achieving Enteral Autonomy in Pediatric Intestinal Failure. (Mentor: Dr. David Galloway)
Stephen D. Gragg presented Hypomethylation of ADORA1, SBNO2, and WIZ is associated with risk of multiple myeloma, smouldering myeloma, and monoclonal gammopathy of undetermined significance. (Mentor: Dr. Elizabeth Brown) 
Joann Hsu presented Aspirin Use and Long-Term Rates of Sepsis: A Population-Based Cohort Study. (Mentor: Dr. Henry Wang) 
Timothy J. Kennell Jr. presented The Almighty, Overridden Clinical Decision Support Alert. (Mentor: Dr. James J. Cimino) 
Alexandra B. Khodadadi presented on Assessing Community Members' Preferences of a Family-Based Diabetes Prevention Program in Rural Alabama. (Mentor: Dr. Andrea Cherrington) 
Matthew B. Neu presented on Initial Whole Genome Analysis of SFARI Phase I. (Mentor: Dr. Greg Cooper). 
Kristin M. Olson presented A Case for Point-of-Care Testing for Chlamydia and Gonorrhea in the Emergency Department Setting. (Mentor: Dr. William Geisler) 
Anna Joy Rogers presented on Missed Opportunities for Repeat HIV Testing and Early ART Initiation during Pregnancy in Southwestern Kenya. (Mentor: Dr. Janet Turan)
How does one prepare for a career in academic medicine? And once hired, how does one move up? Who better to answer such questions for a room full of junior faculty and medical students than a former senior vice president and dean of the UAB School of Medicine? Dr. Robert Rich, currently professor of Medicine, Microbiology, and Medical Education, joined the CCTS on Nov. 16 to share his best tips on Preparation, Negotiation, and Promotion for Researchers in Academic Medicine. Below are a few of the highlights:
- You will not learn how to do clinical research in medical school; the best way to learn it is via a Master’s in Public Health (MPH) or Master’s of Science in Clinical Research (MSCR) degree. Also consider spending at least a year as a research intern; it takes time to become a seasoned scientist, same as it does to become a medical doctor. (Editor’s note: May we suggest the Also, which provides a year of mentored translational research experience culminating in an MS or MSPH?)
- The NIH K series, which supports aspiring researchers at the undergraduate, graduate, and postdoctoral levels, is a wonderful program, providing career development support for five years. The success rate on grant applications submitted by former K awardees is around 50% higher than those submitted by researchers who have never had a K.
- You need to have a sense of where you fit in the translational research pathway. Although one can move from the lab to working with patients in a clinical setting, skills and training are highly variable depending on where one is on the translational spectrum. (Editor's note: It takes a team of scientists from across the translational spectrum, each representing unique areas of research expertise, to move discoveries from the bench to the bedside and beyond to the community, where they can have a real impact on health care.)
- Explicitly negotiate at least 50% protected time for the first 3 to 5 years of a position as a lab-based investigator. If a “dry-lab” clinical investigator on the tenure track, you may ask for up to 75% protected time; non-tenures should negotiate at least 25-50% protected time.
- Talk to new assistant professors to find out what it’s like at a particular institution, did they keep their promises about start-up packages, which generally range from $600-1.2 million over three years for a lab-based investigator (the dry lab clinical investigator package range is less, generally $300-700k).
- Understand what kind of institution is best for you—one that is research-intensive or one where teaching and clinical practice predominate.
- Access the collaborative opportunities available at UAB, which is one of the most highly collaborative academic medical research institutions in the country. Working in a silo is not a fun way to do research.
- Regardless of career path chosen, identify a senior faculty mentor who knows the institutional ropes. Understand whether or not promotion and tenure are tied together as this can differ substantially between institutions.
- Seek out leadership opportunities and develop a reputation for dependability—deliver on any assignments you accept.
- Investigate funding and collaborations via institutional programmatic grants, usually under the supervision of a senior colleague—often the best way to get started.
- Submit grant applications to more than one external funding agency. Give yourself plenty of time and take advantage of internal review and critique programs (Editor’s note: Like the panel program of CCTS Research Commons!).
To learn more about negotiation skills, check out this video by Dr. Stephen Yoder at a CCTS TIERS seminar earlier in 2016, available on the CCTS YouTube channel. Bookmark our TIERS page so you don’t miss a single seminar in 2017! Check out other CCTS events for additional opportunities to learn and grow, network and collaborate.
One of the most common reasons a clinical trial fails is poor recruitment—it can be difficult to find enough patients who meet a trial’s eligibility criteria. To address this challenge, UAB joined TriNetX, a clinical data network of healthcare providers, pharmaceutical companies, and contract research organizations that connects clinical researchers to trial opportunities based on the patient populations they wish to study.
TriNetX uses the i2b2 (Informatics for Integrating Biology and the Bedside) framework, designed by an NIH-funded initiative to facilitate translational research. i2b2 is designed to enable enterprise-wide searches of de-identified health information. Researchers can use i2b2 to determine aspects of study feasibility by identifying whether a sizable number of patients exist that meet their study inclusion/exclusion criteria (CCTS offers a hands-on i2b2 training that teaches this and more). The TriNetX network does the same thing but across several dozen linked institutional i2b2 instances, including those at CCTS Partners UAB and Tulane, to provide query capability into the data of potentially millions of patients. As UAB Informatics Institute Director Dr. James J. Cimino explained, "Whether you are looking for population data to answer a research question or wanting to recruit subjects for a prospective study, our participation with TriNetX will multiply the number of patients you can reach."
TriNetX increases research opportunities in two ways:
- When a collaborating sponsor would like to stand up a clinical trial, it approaches TriNetX and requests a query of the electronic health records of all participating academic medical institutions via i2b2. Those sites with sufficient patients that meet eligibility criteria are contacted to invite participation. When UAB is identified as having a sufficient patient population for a given trial, the CCTS Research Commons fields the request, reaching out to the investigator-base at the Hub to identify potential site leads.
- TriNetX also provides a foundation to support collaboration with peers and other member institutions. Using the same data framework and connections, academic sites can exchange data with each other to promote multisite investigation. The CCTS has created such a network with the University of Kentucky and is in the process of establishing similar capacities with other CTSA Hubs, including Emory, Medical University of South Carolina, and University of Arkansas. Additional sites are expected to come online in 2017, including CCTS Partners.
Advantages
Through TriNetX, CCTS investigators benefit from increased opportunities to participate in industry-sponsored clinical trials that are feasible and of scientific interest. Since going live on the TriNetX network in December 2015, UAB has experienced a steady increase of trial opportunities, from one a month to weekly inquiries. These studies cover a range of diseases, including cancer, neurologic conditions, diabetes, inflammatory conditions, and genetic diseases. As a result of this partnership, trials have begun in Multiple Sclerosis and Nasopharyngeal Cancer under the leadership of Dr. Khurram Bashir and Dr. Lisle Nabell, respectively. Several other trials are pending.
Those trial units or investigators who are interested in learning more about trial opportunities are invited to contact Research Commons (
To learn more about i2b2, TriNetX, and the Shared Health Resource Informatics Network (SHRINE), mark your calendar for our next CCTS Forum on Wednesday, Dec. 7, which will explore how these informatics initiatives are transforming clinical research.
The CCTS would like to thank its Informatics team for their critical support, working closely with TriNetX to establish and maintain the infrastructure to support detailed data queries at the CCTS Hub and helping train CCTS investigators on how to use i2b2 for hypothesis testing, cohort estimation, and patient recruitment.
The goal of the project, the EHR Access to Seamless Integration of PROMIS (EASI-PRO), is to make it easier for investigators and clinicians to collect patient-reported information and use it to improve clinical care and research. PROMIS (the Patient Reported Outcomes Measurement Information System), a computerized survey tool that adapts to each patient’s unique answers, will be added to the EHR of patients enrolled in clinical studies, along with their medical information. This will enable comparison of medical information with outcome survey responses, “which studies have shown is one of the best ways to improve health care quality and the impact of research,” according to Northwestern, which has already integrated PROMIS into its Medicine EHR.
Integration of PROMIS into a large number of EHRs will enable health care systems across the country to administer the same patient-reported outcomes surveys and compare the results. Because it is adaptive, PROMIS also has the potential to make patient-reported outcomes surveys up to 10 times shorter, making it less of a burden on those who take it.
The Easi-PRO team is building software that will integrate PROMIS into Cerner and Epic EHRs. At UAB, the plan is “to move patient outcomes data into i2b2 as soon as PROMIS is integrated into Cerner,” said UAB Informatics Institute Director Dr. James J. Cimino, one of the co-PIs on the grant. He anticipated this would occur in Year 2 (~ 2018).
Cimino explained the project represents an important development in the history of EHRs. “The mechanisms we use for capturing and storing these data will be archetypes for all sorts of additional data, such as patient preferences, advance directives, and the like. We cannot move to the next-generation EHR until the patient is able to be a full partner in contributing to the system. This is a step in that direction.”