- october 2017 -

INSIDE THIS ISSUE

1. What Makes Us TIC
2. PI Message
3. Message from Executive Director
4. Clinical Trials Office
5. Utah Center for Clinical & Translational Science
6. Institutional Review Board
7. Office of Sponsored Projects
8. Division of Pediatric Critical Care, Research Admin
9. Clinical Research Enterprise Innovation Program
10. Value Engineering

What Makes Us TIC

The Utah Trial Innovation Center, or Utah TIC, was funded by the NIH National Center for Advancing Translational Science (NCATS) in July 2016, and is part of the larger Trial Innovation Network. The seven-year, $25 million grant was awarded to Dr. J. Michael Dean, MD, MBA, professor and vice chairman for research in the Department of Pediatrics. The Trial Innovation Network is an exciting opportunity and combines three TICs (Utah, Johns Hopkins/Tufts, Duke/Vanderbilt) with one Recruitment Innovation Center (Vanderbilt) and approximately 60 existing CTSA Program Hubs, including the Utah Center for Clinical & Translational Science (CCTS).

The vision for the network is to address critical roadblocks in clinical trials and to accelerate the translation of novel interventions into life-saving therapies while implementing innovation every step of the way. Operational innovation, operational excellence and collaboration are the network cornerstones. For more information, visit the Trial Innovation Network website.

The Utah TIC has helped to provide financial support for key University of Utah clinical research stakeholders and infrastructure, including the Data Coordinating Center, the Institutional Review Board, the Office of Sponsored Projects, the Clinical Trials Office and the CCTS. This newsletter provides a forum for disseminating information about these valuable Institutional collaborations and the progressive work being done here in the intermountain west.

A Message from the Principal Investigator of the Utah TIC

By Mike Dean, MD

The Utah TIC entered its second year of funding beginning July 1, 2017 and it has been a busy year! We have hired many new personnel to carry out the ambitious goals of the TIC and the Trial Innovation Network. Our group has led the Trial Innovation Network efforts to make the central IRB (CIRB) functional for multicenter studies, with incredible assistance from Ann Johnson, IRB interim director, and her colleagues. We have begun working on several upcoming trials, and the Trial Innovation Network now has a portal for entering new investigative ideas from faculty at all CTSA organizations. Click here to access the portal.

The most important message at the beginning of year 2 is that the Trial Innovation Network is open to all faculty at the University, as well as our affiliated partners. Investigators who have a good idea for a clinical trial should contact the University of Utah CCTS Hub Liaison Team to discuss how they might bring their multicenter clinical trial to the Trial Innovation Network for potential implementation. This will provide investigators with access to the entire CTSA consortium, with approximately 60 Hub institutions and over 500 affiliated hospitals around the country. For further information about this process, feel free to contact Dixie Thompson at HLT@utah.edu or 801-587-4809, who is part of the Utah Hub Liaison Team when she is not working directly inside the TIC.

Please join me and our entire Utah TIC team in making the upcoming year memorable for contributions of important clinical investigations from the talented faculty at the University of Utah.

A Message from the Executive Director of the Utah TIC

By Jeri Burr

At a pre-award meeting in Washington, DC last summer, Dr. Dean and I were surrounded by the best and brightest from Duke, Vanderbilt, Johns Hopkins, Tufts and Harvard universities. Dr. Dean said to me, "We are in the big leagues now." I concur! As a Data Coordinating Center (DCC), we have developed expertise in functioning as an Academic Research Organization (ARO) managing large multi-center studies. Our DCC staff have become very good at what they do in project management, clinical data management and biostatistics. As a Trial Innovation Center, we are now tasked with doing it better. In order to make that happen, the Utah TIC has assembled an extraordinary team of project managers, clinical data mangers, business analysts, biostatisticians, informaticists and experts in information technology, contracting and regulatory work. This team is self-motivated and talented. It has been a privilege to work with such a high-functioning team this past year. Our Utah TIC has had the opportunity to pave the way in many areas, such as leading the charge in the CIRB process, jumping out of the gate as the first TIC to get three demonstration projects approved, up and running; and developing innovative processes that will pave the way for large clinical trials to come. Our Innovation Team is impressive in their efforts to strategize best practices for the innovation, optimization, and improvement. Their work is helping the entire team be more efficient and do our jobs better. Our new Business Analyst team is tracking the metrics that tell our story and mapping our work to show why we are so good at what we do. Stellar work is being accomplished by all of our teams including those working on consultations, data management and harmonization, IT solutions, communications, standardized agreements and contracting. We recently had the opportunity to showcase our team during an all-day meeting with the Johns Hopkins TIC team, who flew to Utah to learn about our operations. After our presentations were completed, the Hopkins Project Lead (PL) said, "We are very humbled by what we have seen here today." After working with this dream team for almost a year now, I agree with Hopkins and look forward to a bright future for our Utah Trial Innovation Center.

Clinical Trials Office

By Jaci Skidmore

“Gemba” is a Japanese word meaning "the real place." In the context of innovation and overall process improvement, “going to the Gemba” means going where the change is taking place and where value is created. It is an approach to help us identify the obstacle we are trying to solve and to create ideas for improvement of those processes. Being part of the Utah TIC is “going to the Gemba.”

As part of our own continuous improvement efforts, and to improve upon existing internal processes, the CTO contracting team and budgeting team are working to improve efficiency for optimization and meeting new standards of quality. The Utah TIC Investigational New Drug/Investigational Device Exemption (IND/IDE) team has completed two FDA Pre-IND meetings. The Utah TIC’s ValEAR demonstration project was submitted and has received FDA approval to begin.

Utah Center for Clinical & Translational Science (CCTS)

By Dixie Thompson

We recognize the national acclaim that the competitive NCATS award brings to our institution and are honored to collaborate with Dr. Dean on this initiative to improve clinical research operations. In year one, the CCTS has created a Hub Liaison Team to facilitate the mission of the Trial Innovation Network. University of Utah Investigators will access the resources of the TIC and the Trial Innovation Network through the CCTS Hub Liaison Team. Requests can be made by contacting Dixie Thompson at HLT@utah.edu or 801-587-4809.

The CCTS has leveraged institutional strengths in clinical trials recruitment, innovation, performance, and management to ensure that it is fully prepared to participate actively as a Trial Innovation Network Hub Liaison Team. CTSA PIs, Dr. Willard Dere and Dr. Rachel Hess, and CCTS Clinical Trials Support Foundation Director, Dr. J. Robinson Singleton, are engaged and closely aligned with the goals and activities of Dr. Dean and the Utah TIC. For more info about the CCTS, click here.

Institutional Review Board

By Ann Johnson

The University of Utah TIC is leading the IRB working group to developing the CIRB workflow to be used at Utah. In collaboration with NCATS and the other TICs, we have made enhancements to the IRB software system, Electronic Research Integrity and Compliance (ERICA), to better suit the needs of a CIRB study, development of an electronic consent builder, and initiation of reliance relationships with many institutions that are participating sites in the three Utah TIC development projects.

The first development project called ValEAR, a randomized controlled trial of Valganciclovir for asymptomatic cytomegalovirus infected hearing- impaired infants submitted by Albert Parks, MD, received CIRB approval for the lead site in May.

The working group has also significantly contributed to the development of CIRB processes for trials using an Exception from Informed Consent (EFIC). The University of Utah IRB is happy to be collaborating on the TIC and have dedicated the time of our most experienced staff to support this important work at the U.

Office of Sponsored Projects

By Brent Brown

In year one, we added 3 attorneys with expertise in contracts and clinical trials to work on the TIC. The Utah TIC, in collaboration with other TICs and the CTSA Network, helped finalize the FDP Fixed Price Clinical Trials Sub-award Agreement (FDP-CTSA) to streamline the administration of federally sponsored clinical trials. Together, the TICs identified frequently negotiated contract language that has historically resulted in contracting delays. The TICs worked together to create an agreement acceptable to CTSA sites and potential non-CTSA sub-sites. Additional information about the FDP-CTSA can be found here.

Division of Pediatric Critical Care, Research Administration

By Jan Johnson

The Data Coordinating Center (DCC) has a unique role when it comes to running clinical trials. We are able to help plan and develop ideas that turn into clinical trials. We sometimes train and advise investigators on how to run randomized controlled trials (RCTs). We lead, educate, advise, support, manage and follow all activities around clinical trials for multiple groups. There are specific roles at the DCC that act as experts in each area necessary to successfully carry out a trial: Clinical Data Managers, PhD and Master’s level statisticians, Project Managers, and IT Support. We work as a team in order to run high quality, efficient, and cost effective clinical trials. Currently the DCC supports 11 networks and 30 ongoing studies taking place across the country and around the world. The DCC is housed in the Department of Pediatrics Critical Care Medicine, but not all networks are pediatric networks some are adult.

Research on a Napkin and Stat Chat

Investigators from across health sciences are invited to join Research on a Napkin held the third Friday or Stat Chat held the 4th Friday from 9-10 am at the Williams Building. Research on a Napkin is an unstructured drop-in meeting where potential investigators can bring their specific research questions and ideas to discuss with DCC staff around the table. It’s an open forum for clinicians and fellows to develop concepts. Stat Chat’s target audience is clinical or research faculty, fellows or staff. It’s also a drop-in format where anyone seeking help with statistical questions on new or existing projects may meet with experienced DCC statistical staff.

clinical research enterprise innovation program

By Marie Kay

In response to Utah’s recognition as 1 of 3 Trial Innovation Center’s nationwide, the Utah Data Coordinating Center established an Innovation Team in November 2016. Their objective is to accelerate the translation of research to the bedside for the benefit of the patient through efficient, high-quality, value-driven methods, innovations, and operational improvements. This team is currently piloting a new software called IdeaScale. It is an idea management platform that uses crowdsourcing to take good ideas from inspiration to implementation. It is a large undertaking that the Innovation team will help facilitate and pilot within the Division. Other early innovative initiatives in progress by various personnel within the Trial Innovation Center and Data Coordinating Center include:

• a Division of Pediatric Critical Care e-newsletter focused on research operations and initiatives
• a central Resource Hub to house collective resources (i.e. shared database for Business Associate and Data Use agreements, a catalogue of research tools and systems used) among employees (e.g., Project Management, Biostatistics, Clinical Data Management, IT)
• enhanced employee onboarding program
• centralized manuscript tracking process across studies and networks
• initiation of a clinical research database to track study-level metadata that will help assess performance and areas for strategic improvement
• improved personnel time-tracking efforts to better understand project efforts
• various efforts to improve quality and compliance
• introduction of a Clinical Trials Day event for research personnel on trial facilitation and design

To continue fostering a culture of innovation and improvement, the Innovation Team is also working with Luca Boi, Senior Value Engineer, to identify and operationalize an idea management process among a multi-faceted research organization and looks forward to many exciting initiatives to come!

Value Engineering

By Luca Boi

Luca Boi, a senior Value Engineer from University of Utah Health, started meeting with Trial Innovation Center staff to review processes and identify areas of opportunities for improvement. His expertise in process improvement translates beautifully into helping accomplish the mission of the innovation network. He is working with Dr. Mike Dean and senior management to discuss the strategy needs and direction to guide improvement efforts at the TIC. The conversation lead to the definition of value: “Fastest translation of new ideas to the bedside, for the benefit of the patient.”

The Innovation Team is looking to review existing methodology, strategy, and define a more unified plan of action for facilitating and sharing improvement within the network. Luca has also been working with Erin Rothwell, Director of Evaluation for the CCTS to strategize how to roll out improvement plans to follow the metrics discussion with the CCTS foundations.

The Health Science Value Principles course will be offered on October 27 and November 1. This interactive course is an introduction to the University Health Care value improvement methodology and most commonly used principles and tools in value work.

Participants will learn about the principle of value and non-value added activities, the value added test and its application in their work; process mapping; creating a standard work; how to select an improvement project; the 5 steps in the value summary improvement methodology; and a review of the resources available to help them in their journey to continuous improvement. Discuss opportunities for improvements in your work, and share your experiences with the group.

Class registration and more information is here: Health Sciences Value Principles.