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  1. Article ; Online: Using a multicultural and multilingual awareness-raising strategy to enhance enrollment of racially underrepresented minoritized communities – the PassITON trial

    Jasmine Bell / Sarah Cook / Terri L. Edwards / Todd W. Rice / Wesley H. Self / Allison Wheeler / Jillian Rhoads / Thomas G. Stewart / Jill M. Pulley / Katelyn Benhoff / Paul A. Harris / Consuelo Wilkins

    Journal of Clinical and Translational Science, Vol

    2023  Volume 7

    Abstract: Racially and ethnically minoritized populations have been historically excluded and underrepresented in research. This paper will describe best practices in multicultural and multilingual awareness-raising strategies used by the Recruitment Innovation ... ...

    Abstract Racially and ethnically minoritized populations have been historically excluded and underrepresented in research. This paper will describe best practices in multicultural and multilingual awareness-raising strategies used by the Recruitment Innovation Center to increase minoritized enrollment into clinical trials. The Passive Immunity Trial for Our Nation will be used as a primary example to highlight real-world application of these methods to raise awareness, engage community partners, and recruit diverse study participants.
    Keywords Recruitment ; retention ; diversity ; community outreach ; multicultural awareness ; multilingual awareness ; health communication ; racial minorities ; health disparities ; research access ; Medicine ; R
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: The RIC COVID-19 Recruitment & Retention Toolkit

    Nan Kennedy / Julia Dunagan / Leslie R. Boone / Tiffany Israel / Stephanie A. Mayers / Leah Dunkel / Sarah Cook / Pamela Pimentel / Terri L. Edwards / Mary Stroud / Consuelo H. Wilkins / Paul A. Harris

    Journal of Clinical and Translational Science, Vol

    A community-informed resource of recruitment tools and strategies for clinical trial investigators

    2022  Volume 6

    Abstract: The Recruitment Innovation Center (RIC) has created a toolkit of novel strategies to engage potential participants in response to recruitment and retention challenges associated with COVID-19 studies. The toolkit contains pragmatic, generalizable ... ...

    Abstract The Recruitment Innovation Center (RIC) has created a toolkit of novel strategies to engage potential participants in response to recruitment and retention challenges associated with COVID-19 studies. The toolkit contains pragmatic, generalizable resources to help research teams increase awareness of clinical trials and opportunities to participate; produce culturally sensitive and engaging recruitment materials; improve consent and return of results processes; and enhance recruitment of individuals from populations disproportionately impacted by COVID-19. This resource, the “RIC COVID-19 Recruitment and Retention Toolkit,” is available free online. We describe the toolkit and the community feedback used to author and curate this resource.
    Keywords COVID-19 ; clinical trial recruitment ; participant retention ; toolkit ; community engagement ; Medicine ; R
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Securely sharing DSMB reports to speed decision making from multiple, concurrent, independent studies of similar treatments in COVID-19

    Natalie A. Dilts / Frank E. Harrell / Christopher J. Lindsell / Samuel Nwosu / Thomas G. Stewart / Matthew S. Shotwell / Jill M. Pulley / Terri L. Edwards / Emily Sheffer Serdoz / Katelyn Benhoff / Gordon R. Bernard

    Journal of Clinical and Translational Science, Vol

    2022  Volume 6

    Abstract: Abstract Introduction: As clinical trials were rapidly initiated in response to the COVID-19 pandemic, Data and Safety Monitoring Boards (DSMBs) faced unique challenges overseeing trials of therapies never tested in a disease not yet characterized. ... ...

    Abstract Abstract Introduction: As clinical trials were rapidly initiated in response to the COVID-19 pandemic, Data and Safety Monitoring Boards (DSMBs) faced unique challenges overseeing trials of therapies never tested in a disease not yet characterized. Traditionally, individual DSMBs do not interact or have the benefit of seeing data from other accruing trials for an aggregated analysis to meaningfully interpret safety signals of similar therapeutics. In response, we developed a compliant DSMB Coordination (DSMBc) framework to allow the DSMB from one study investigating the use of SARS-CoV-2 convalescent plasma to treat COVID-19 to review data from similar ongoing studies for the purpose of safety monitoring. Methods: The DSMBc process included engagement of DSMB chairs and board members, execution of contractual agreements, secure data acquisition, generation of harmonized reports utilizing statistical graphics, and secure report sharing with DSMB members. Detailed process maps, a secure portal for managing DSMB reports, and templates for data sharing and confidentiality agreements were developed. Results: Four trials participated. Data from one trial were successfully harmonized with that of an ongoing trial. Harmonized reports allowing for visualization and drill down into the data were presented to the ongoing trial’s DSMB. While DSMB deliberations are confidential, the Chair confirmed successful review of the harmonized report. Conclusion: It is feasible to coordinate DSMB reviews of multiple independent studies of a similar therapeutic in similar patient cohorts. The materials presented mitigate challenges to DSMBc and will help expand these initiatives so DSMBs may make more informed decisions with all available information.
    Keywords Data and Safety Monitoring Boards (DSMBs) ; trial monitoring ; data harmonization ; safety monitoring ; data sharing/pooling ; Medicine ; R
    Subject code 306
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Development, implementation, and dissemination of operational innovations across the trial innovation network

    Marisha E. Palm / Terri L. Edwards / Cortney Wieber / Marie T. Kay / Eve Marion / Leslie Boone / Angeline Nanni / Michelle Jones / Eilene Pham / Meghan Hildreth / Karen Lane / Nichol McBee / Daniel K. Benjamin / Gordon R. Bernard / J. Michael Dean / Jamie P. Dwyer / Daniel E. Ford / Daniel F. Hanley / Paul A. Harris /
    Consuelo H. Wilkins / Harry P. Selker

    Journal of Clinical and Translational Science, Vol

    2023  Volume 7

    Abstract: Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are ... ...

    Abstract Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.
    Keywords Trial innovation network ; CTSA ; clinical trials ; clinical trial roadblocks ; innovation ; Medicine ; R
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Decentralized clinical trials in the trial innovation network

    Daniel F. Hanley / Gordon R. Bernard / Consuelo H. Wilkins / Harry P. Selker / Jamie P. Dwyer / J. Michael Dean / Daniel Kelly Benjamin / Sarah E. Dunsmore / Salina P. Waddy / Kenneth L. Wiley / Marisha E. Palm / W. Andrew Mould / Daniel F. Ford / Jeri S. Burr / Jacqueline Huvane / Karen Lane / Lori Poole / Terri L. Edwards / Nan Kennedy /
    Leslie R. Boone / Jasmine Bell / Emily Serdoz / Loretta M. Byrne / Paul A. Harris

    Journal of Clinical and Translational Science, Vol

    Value, strategies, and lessons learned

    2023  Volume 7

    Abstract: New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by ... ...

    Abstract New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
    Keywords Decentralized trials ; hybrid trials ; CTSA ; trial innovation network ; inclusive recruitment ; remote trials ; remote technology ; rural recruitment ; remote recruitment ; remote intervention ; remote data collection ; MyCap ; remote trial monitoring ; Medicine ; R
    Subject code 610
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

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  6. Article ; Online: We’re not all cut from the same cloth

    Rebecca N. Jerome / Jill M. Pulley / Terri L. Edwards / Alyssa B. Dickerson / Douglas Conway / Sara L. Van Driest / Gordon R. Bernard / Paul A. Harris

    Journal of Patient-Reported Outcomes, Vol 3, Iss 1, Pp 1-

    TAILORing treatments for children with chronic conditions

    2019  Volume 8

    Abstract: Abstract Background Finding the optimal treatment for a chronic condition can be a complex and lengthy endeavor for both the patient and the clinician. To address this challenge, we developed an “N-of-1” quality improvement infrastructure to aid ... ...

    Abstract Abstract Background Finding the optimal treatment for a chronic condition can be a complex and lengthy endeavor for both the patient and the clinician. To address this challenge, we developed an “N-of-1” quality improvement infrastructure to aid providers and patients in personalized treatment decision-making using systematic assessment of patient-reported outcomes during routine care. Methods Using the REDCap data management infrastructure, we implemented three pediatric pilots of the Treatment Assessments in the Individual Leading to Optimal Regimens (TAILOR) tool, including children receiving early intervention, children with attention deficit hyperactivity disorder, and children with challenging behaviors in the classroom setting. This retrospective review of data summarizes utilization and satisfaction data during our pilot experience with the tool. Results The three pilots included a combined total of 109 children and 39 healthcare providers, with 67 parents and 77 teachers invited to share data using brief surveys administered using TAILOR. Overall survey response rates ranged from 38% to 84% across the three pilots, with response rates notably higher among teachers as compared with parents. Satisfaction data indicated positive impressions of the tool’s utility. Discussion These experiences show the utility of the TAILOR framework for supporting collection and incorporation of patient-reported outcomes into the care of individuals with chronic conditions.
    Keywords Personalized medicine ; Autism spectrum disorders ; Attention deficit hyperactivity disorder ; N-of-1 studies ; Patient reported outcomes ; Patient engagement ; Public aspects of medicine ; RA1-1270
    Subject code 360
    Language English
    Publishing date 2019-04-01T00:00:00Z
    Publisher SpringerOpen
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

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  7. Article ; Online: The Recruitment Innovation Center

    Consuelo H. Wilkins / Terri L. Edwards / Mary Stroud / Nan Kennedy / Rebecca N. Jerome / Colleen E. Lawrence / Sheila V. Kusnoor / Sarah Nelson / Loretta M. Byrne / Leslie R. Boone / Julia Dunagan / Tiffany Israel / Casey Rodweller / Bethany Drury / Rhonda G. Kost / Jill M. Pulley / Gordon R. Bernard / Paul A. Harris

    Journal of Clinical and Translational Science, Vol

    Developing novel, person-centered strategies for clinical trial recruitment and retention

    2021  Volume 5

    Abstract: Clinical trials continue to face significant challenges in participant recruitment and retention. The Recruitment Innovation Center (RIC), part of the Trial Innovation Network (TIN), has been funded by the National Center for Advancing Translational ... ...

    Abstract Clinical trials continue to face significant challenges in participant recruitment and retention. The Recruitment Innovation Center (RIC), part of the Trial Innovation Network (TIN), has been funded by the National Center for Advancing Translational Sciences of the National Institutes of Health to develop innovative strategies and technologies to enhance participant engagement in all stages of multicenter clinical trials. In collaboration with investigator teams and liaisons at Clinical and Translational Science Award institutions, the RIC is charged with the mission to design, field-test, and refine novel resources in the context of individual clinical trials. These innovations are disseminated via newsletters, publications, a virtual toolbox on the TIN website, and RIC-hosted collaboration webinars. The RIC has designed, implemented, and promised customized recruitment support for 173 studies across many diverse disease areas. This support has incorporated site feasibility assessments, community input sessions, recruitment materials recommendations, social media campaigns, and an array of study-specific suggestions. The RIC’s goal is to evaluate the efficacy of these resources and provide access to all investigating teams, so that more trials can be completed on time, within budget, with diverse participation, and with enough accrual to power statistical analyses and make substantive contributions to the advancement of healthcare.
    Keywords Translational research ; multicenter clinical trials ; participant recruitment ; participant retention ; CTSA program ; Medicine ; R
    Subject code 020
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: The RIC Recruitment & Retention Materials Toolkit – A resource for developing community-informed study materials

    Stephanie A. Mayers / Sarah K. Cook / Caitlin Rantala / Tiffany Israel / Tara Helmer / Matt Schorr / Guadalupe Campos / David Hahn / Pamela Pimentel / Mysha Wynn / Terri L. Edwards / Mary Stroud / Paul A. Harris / Consuelo H. Wilkins

    Journal of Clinical and Translational Science, Pp 1-15

    Keywords Medicine ; R
    Language English
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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