- Developing Policies and Practices to Leverage Data Innovation to Promote Study Recruitment
- Enhancing CTSA Capacity Through Multi-Institutional Data Warehousing
- I-CorpsTM at NCATS Program
- Innovation Labs to Enhance CTSA Program Network Capacity
- Innovative Video Consenting for Precision Medicine
- Multi-CTSA Mini-Sabbatical Evaluation and Quality ImprovemeNt (SEQUIN)
- N-Lighten Network: A Federated Platform for Education Resource Sharing
- Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
- SPARCRequest©: An e-commerce Solution for Multisite Research and Clinical Trials
- Trial Finder
Developing Policies and Practices to Leverage Data Innovation to Promote Study Recruitment
Principal Investigator: Robert S. Sherwin, M.D.
Contact: Tesheia Johnson
Yale proposes to collaborate with the Rockefeller and Washington University CTSA Program hubs to disseminate an approach that Yale has implemented to enhance its recruitment to clinical trials through institutional change. The goal is for the three hubs to exchange scientific information regarding the implementation of:
- systems and models for patients to opt in or opt out of their data being used for recruitment to clinical trials and for clinical research,
- electronic IRB management systems,
- grants management platforms, and
- clinical research or trial management systems.
The project will leverage both the research management strengths of each partnering hub and the institutional investments in technology platforms, educational resources and development of best practice standards at each institution. The exchange will focus on processes for expanding the participation in clinical and translational research by leveraging electronic health records and other technology, along with a translation and dissemination strategy that is likely to be transferable across the CTSA Program. A national framework could emerge that would aid each CTSA Program hub in applying modern informatics and common best practices to accelerate participant recruitment to clinical trials.
Enhancing CTSA Capacity Through Multi-Institutional Data Warehousing
University of California, Los Angeles
Principal Investigator: Steven M. Dubinett, M.D.
Contact: Doug Bell
Modern scientific discoveries require larger populations of data, which are seldom available to individual institutions. Unfortunately, provisioning research data from federated systems requires data extraction from separate patient data warehouses at each institution, and the resulting data often are poorly normalized, with substantial data missing and with additional data on patients who are not actually comparable. This CTSA Program administrative supplement will fund the evaluation of the potential utility of the Big Healthcare Data Initiative for providing high-quality research data sets, with a particular focus on data that could simultaneously inform performance improvement and clinical science. Specifically, with the aid of this supplement, the project investigators will:
- Implement a data research prioritization process as a component of the governance process being established for a multi-institutional centralized data warehouse;
- Assess the results of provisioning data to address high-priority research questions from a multi-institutional centralized data warehouse in comparison with data extracted from single institution data warehouses, in terms of (a) completeness and accuracy, and (b) efficiency of effort;
- Implement corrections in data harmonization and data processing to address challenges identified from assessments of research data obtained from the centralized warehouse; and
- Disseminate lessons learned in implementing research data provisioning from a multi-institutional centralized clinical data warehouse through publications, presentations and open-source code sharing.
The proposed supplement is in line with the CTSA Program mission, as it will enable investigators to evaluate the utility of a unified data warehouse for providing high-quality research data sets, disseminate lessons learned to the entire CTSA Program network and lay the foundation for more impactful, multi-CTSA Program hub research. The results of the proposed project will serve to guide data warehousing and data provisioning activities among the nation’s CTSA Program institutions, forming a foundation for more impactful translational research spanning multiple CTSA Program institutions.
I-Corps at NCATS Program
University of Alabama at Birmingham
Principal Investigator: Robert P. Kimberly, M.D.
Contact: Molly Wasko, Ph.D.
This project is a collaborative effort among nine CTSA Program hubs: University of Alabama at Birmingham, Georgia Institute of Technology (part of the Emory University hub), Pennsylvania State University, Rockefeller University, University of California, Davis, University of Colorado Denver, University of Miami, University of Massachusetts, and University of Michigan. University of Alabama at Birmingham researchers aim to adapt and disseminate the existing National Science Foundation (NSF) Innovation Corps (I-CorpsTM) and I-CorpsTM at NIH programs to meet the needs of researchers and clinicians at academic medical centers. The overarching aims are:
- Develop a uniform, four-week curriculum that will be considered part of the official I-CorpsTM body of knowledge, specific to the commercialization of clinical and translational research discoveries;
- Build capacity locally and regionally across CTSA Program hubs through a regional Train-the-Trainer program; and
- Establish common metrics and an evaluation framework to assess the effectiveness and impact of the I-CorpsTM at NIH program across CTSA Program institutions.
Like the NSF and NIH I-CorpsTM programs, this project prepares scientists and engineers to extend their focus beyond the university laboratory and accelerates the economic societal benefits of select basic research projects that are ready to move toward commercialization.
Innovation Labs to Enhance CTSA Program Network Capacity
University at Buffalo, State University of New York
Principal Investigator: Timothy F. Murphy, M.D.
Contacts: Timothy F. Murphy, M.D., and Larry Hawk, Ph.D.
An Innovation Lab is a promising and revolutionary means for constructing new interdisciplinary teams and stimulating novel research solutions across the CTSA Program consortium. Participants — along with a director, organizers, subject matter guides and Knowinnovation facilitators — communally explore a problem in space, generate a broad range of ideas and form transdisciplinary teams to pursue research projects. The Innovation Lab targets early-stage investigators who have limited networks and opportunities for collaboration and during an opportune time in their careers when this experience may launch their independent — yet interdisciplinary and collaborative — research programs. The project is a collaboration between the University at Buffalo and Vanderbilt University Medical Center CTSA Program hubs and the Knowinnovation facilitation team. The team will achieve the following specific aims:
- With ongoing input from multiple stakeholders (NCATS, CTSA Program hubs and Domain Task Forces) the team will develop, run and track the impact of two pilot Translational Workforce Development Innovation Labs (one at University at Buffalo and one at Vanderbilt University), and
- Evaluate the impact of the Innovation Labs in a randomized controlled that randomly assigns matched applicants to an Innovation Lab or a “treatment as usual” control group.
At the conclusion of this project, the investigators will have demonstrated the effectiveness of an innovative approach to developing new and interdisciplinary teams of young investigators that are prepared to tackle challenges in translational science.
Innovative Video Consenting for Precision Medicine
University of California, Los Angeles
Principal Investigator: Steven M. Dubinett, M.D.
Contact: Arash Anaeim
Revolutions in genomic and information technologies have created unprecedented opportunities to advance the diagnosis and treatment of disease across the entire spectrum of medicine. However, to fully accomplish these goals, it is essential to collect genomic and clinical data from a very large and diverse patient population in an ethical, informed manner without disrupting the clinical flow for patients, staff and providers in high-volume centers. This CTSA Program administrative supplement will strengthen collaboration among five CTSA Program hubs (US BRAID: University of California, Davis; University of California, Irvine; University of California, Los Angeles; University of California, San Diego; and University of California, San Francisco) for developing and applying novel approaches to informed consent, including the use of remote (telemedicine) consenting, in order to enable a diverse population of patients to have access to research participation. Specifically, with the aid of this supplement, the project will:
- Develop and pilot a revised video/electronic consenting approach;
- Validate and pilot test a tiered consenting process;
- Create 20 personalized video vignettes in support of biobanking consent; and
- Create a Community Advisory Board to enhance community outreach.
This collaborative effort to enhance informed consent and foster recruitment is in line with CTSA Program goals of enhancing research methods and fostering communication among CTSA Program hubs to make clinical and translational trials more efficient. The project investigators will develop a novel consenting tool, determine best practices across five CTSA Program hubs, and ensure that the resulting developments are scalable across the entire network and beyond.
Multi-CTSA Mini-Sabbatical Evaluation and Quality ImprovemeNt (SEQUIN)
University of Alabama at Birmingham
Principal Investigator: Robert P. Kimberly, M.D.
Contact: Kenneth Saag, M.D.
This supplement will support the dissemination of mini-sabbaticals for KL2 scholars and TL1 trainees designed to enrich career development through experiences complementary to those offered at an investigator’s home institution. The CTSA Program hubs at the University of Alabama Birmingham, New York University and the University of Massachusetts have developed this program among their hubs and are now poised to disseminate this program across the entire CTSA Program through a collaboration with the CTSA Program Coordinating Center, based out of the University of Rochester. Specifically, this supplement will:
- Conduct a national formative evaluation of mini-sabbatical experiences at CTSA Program hubs;
- Use feedback from the evaluation to refine the initial preliminary report on mini-sabbatical “best practices” developed, based on experiences at the three CTSA Program hubs; and
- Build from existing offerings at the three CTSA Program hubs to catalog a national mini-sabbatical to connect CTSA Program scholars and trainees with optimal mini-sabbatical opportunities.
The goal of these mini-sabbaticals is to acquire added competencies in specific areas of translational research, with the experience tailored to meet each investigator’s individual training needs.
N-Lighten Network: A Federated Platform for Education Resource Sharing
Ohio State University
Principal Investigator: Rebecca D. Jackson, M.D.
Contact: Rebecca D. Jackson, M.D.
Researchers at Harvard University, Oregon Health & Science University and The Ohio State University CTSA Program hubs will develop educational resources, tools and technologies and make them available online to trainees, investigators and other members of the translational scientific team. Specifically, with the aid of this supplement, the project strives to:
- Undertake development and proof-of-concept experiments to create the foundation for a CTSA Program-wide federated education resource entitled the N-Lighten Network;
- Identify strategies that create value for CTSA Program hubs, educators and trainees to enhance utilization and engagement of N-Lighten for clinical and translational investigator education and career development; and
- Develop and pilot methodologies to evaluate educational resources based upon use and feedback from diverse trainees across the clinical and translational science spectrum from the two CTSA Program hubs and by clinical and translational science educators drawn from the Workforce Development Domain Taskforce and interested CTSA Program hubs.
At its conclusion, the project will have demonstrated both the feasibility and value of a semantically indexed, federated platform of educational resources, providing the foundation of a CTSA Program-wide N-Lighten Network that can be applied to facilitate and complement the education and training of all members of the clinical and translational workforce.
Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
University of North Carolina at Chapel Hill
Principal Investigator: John B. Buse, M.D., Ph.D.
Contact: John B. Buse, M.D., Ph.D.
While recent medical advances demand new regulatory guidance, few institutions have the breadth of expertise needed to address the unique issues arising from the expanding field of translational science. To that end, representatives of Duke University, the University of North Carolina at Chapel Hill and Wake Forest University CTSA Program hubs will expand an innovative platform, Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD). The platform is designed to share expertise and methodologies across institutions to provide researchers with the tools and resources necessary to find successful pathways from discovery to clinical implementation of new and innovative drugs, biologics, medical devices and therapies. Specifically, this supplement will enhance the collaborative ReGARDD program by:
- Expanding the content of the shared regulatory website to include educational resources that meet and support academic investigators’ regulatory needs;
- Developing the capabilities of the regional regulatory forum to assist academic researchers in navigating an increasingly complex regulatory environment; and
- Disseminating to the CTSA Program network an innovative approach to provide regulatory guidance, share expertise and address regulatory barriers to academic investigators involved in clinical and preclinical research.
Combining the regulatory insight of three North Carolina CTSA Program hubs to share successful strategies and lessons learned could lead to the establishment of a robust, regional outreach program that would facilitate meaningful and fruitful collaborations among multiple stakeholders.
SPARCRequest: An e-Commerce Solution for Multisite Research and Clinical Trials
Medical University of South Carolina
Principal Investigator: Kathleen T. Brady, M.D., Ph.D.
Contacts: Leslie Lenert and Royce Sampson
- MUSC SPARCRequest: https://sparc.musc.edu/
- SPARCRequest Introduction: https://www.youtube.com/watch?time_continue=6&v=Yq7TcdzqAlA
- Using SPARCRequest: https://youtu.be/3sFdLhBlchYSPARCRequest
Researchers at the Medical University of South Carolina will adapt, test, and deploy strategies derived from e-commerce solutions to promote greater collaboration and accelerate the conduct of multisite research and clinical trials within the CTSA Program network — particularly with the launch of the CTSA Program Trial Innovation Network. The electronic storefront program, called SPARCRequest©, aims to support inter-institutional ordering and budgeting of services and resources, as well as tracking of service fulfillment and invoicing. The Medical University of South Carolina CTSA Program hub, in collaboration with the University of Utah and the University of Iowa hubs, will achieve the following overarching aims:
- Develop a governance model to provide a structure for sustainability, decision-making and co-development across CTSA Program hub adopters and other stakeholders for open-source SPARCRequest©;
- Develop, implement, assess and disseminate open-source software that fosters adoption by other institutions, including continuous process improvement and collaborative project management; and
- Support the CTSA Program Trial Innovation Network to optimize efficiency by providing a platform for remote sharing of research resources and rapid multisite budget development.
The goal of the project is to enhance multisite study conduct and realize systematic efficiencies through a collaboratively owned and cooperatively managed electronic marketplace for CTSA Program hubs to order, price and fulfill services and study assessments across the CTSA Program network.
University of California, San Francisco
Principal Investigator: Harold Collard, M.D.
Contact: Harold Collard
Failure to recruit adequate numbers of eligible and diverse participants, combined with the struggle to find investigators that have specific content expertise and experience, often results in lengthy delays and higher costs associated with clinical trials. To address these challenges, representatives of the five University of California CTSA Program hubs aim to help patients and community members easily discover actively enrolling trials and help sponsors and researchers open studies quickly by finding local collaborators. Specifically, with the aid of this supplement, the project investigators will help develop and launch:
- Trial Finder, a platform enabling the public to discover all currently enrolling clinical trials across the University of California CTSA Program network and beyond; and
- Trialist Search, a cross-institutional search tool that facilitates the identification of expert local investigators to collaborate in multisite clinical trials.
While the initial efforts will focus on the University of California, Davis; the University of California, Irvine; the University of California, Los Angeles; the University of California, San Diego; and the University of California, San Francisco CTSA Program hubs, the ultimate goal will be to expedite trial recruitment by disseminating the Trial Finder and Trialist Search approach, software, technical support, and communications strategies across the CTSA Program network and beyond.