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Article ; Online: Key lessons and strategies for implementing single IRB review in the Trial Innovation Network

Ann R. Johnson / Megan Kasimatis Singleton / Julie Ozier / Emily Serdoz / Jennifer G. Beadles / Janelle Maddox-Regis / Sarah Mumford / Jeri Burr / J. Michael Dean / Daniel E. Ford / Gordon R. Bernard

Journal of Clinical and Translational Science, Vol

2022 Volume 6

Abstract: The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has ...

Abstract	The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.
Keywords	IRB ; Single IRB ; Human Research Protection ; Reliance agreement ; Local context ; 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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Article ; Online: Using single IRB consultations to meet the educational needs of investigative teams

Ann R. Johnson / Mary Pautler / Jeri S. Burr / Nael Abdelsamad / John M. VanBuren / Lisa M. Rigtrup / J. Michael Dean / Erin Rothwell

Contemporary Clinical Trials Communications, Vol 29, Iss , Pp 100971- (2022)

2022

Abstract: Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the ... ...

Abstract	Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the written consultation materials and meeting minutes revealed the most common areas of education needed by investigative teams, including (a) the differences and relationships between the IRB and a Human Research Protection Program (HRPP); (b) the main phases of the SIRB process; and (c) the use of technology platforms for documentation of SIRB review processes. For investigative teams who are inexperienced with using a SIRB, such consultation in the pre-award period is likely to fill in knowledge gaps and improve the study start-up process.
Keywords	Single IRB ; Education ; Multicenter trials ; Consultations ; Human research protection program ; Medicine (General) ; R5-920
Language	English
Publishing date	2022-10-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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

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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Article ; Online: The Trial Innovation Network Liaison Team

Journal of Clinical and Translational Science, Vol

building a national clinical and translational community of practice

2023 Volume 7

Abstract: In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ ... ...

Abstract	In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ Clinical and Translational Science Award (CTSA) hubs across the country to support the design and conduct of successful multicenter trials. A dedicated Hub Liaison Team (HLT) was established within each CTSA to facilitate connection between the hubs and the newly launched Trial and Recruitment Innovation Centers. Each HLT serves as an expert intermediary, connecting CTSA Hub investigators with TIN support, and connecting TIN research teams with potential multicenter trial site investigators. The cross-consortium Liaison Team network was developed during the first TIN funding cycle, and it is now a mature national network at the cutting edge of team science in clinical and translational research. The CTSA-based HLT structures and the external network structure have been developed in collaborative and iterative ways, with methods for shared learning and continuous process improvement. In this paper, we review the structure, function, and development of the Liaison Team network, discuss lessons learned during the first TIN funding cycle, and outline a path toward further network maturity.
Keywords	Trial Innovation Network ; CTSA ; clinical trials ; team science ; community of practice ; collaboration ; 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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Article ; Online: Response of the trial innovation network to the COVID-19 pandemic

Rachel G. Greenberg / Lori Poole / Daniel E. Ford / Daniel Hanley / Harry P. Selker / Karen Lane / J. Michael Dean / Jeri Burr / Paul Harris / Consuelo H. Wilkins / Gordon Bernard / Terri Edwards / Daniel K. Benjamin

Journal of Clinical and Translational Science, Vol

2021 Volume 5

Abstract: Abstract Introduction: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an ... ...

Abstract	Abstract Introduction: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic. Methods: The TIN’s three Trial Innovation Centers, Recruitment Innovation Center, and 66 Clinical and Translational Science Award Hub institutions, collaborated to adapt to the pandemic’s rapidly changing landscape, playing central roles in the planning and execution of pivotal studies addressing COVID-19. Our objective was to summarize the results of these collaborations and lessons learned. Results: The TIN provided 29 COVID-related consults between March 2020 and December 2020, including 6 trial participation expressions of interest and 8 community engagement studios from the Recruitment Innovation Center. Key lessons learned from these experiences include the benefits of leveraging an established infrastructure, innovations surrounding remote research activities, data harmonization and central safety reviews, and early community engagement and involvement. Conclusions: Our experience highlighted the benefits and challenges of a multi-institutional approach to clinical research during a pandemic.
Keywords	Trial innovation network ; COVID-19 ; clinical trial ; SARS-CoV-2 ; CTSA ; Medicine ; R
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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Article ; Online: The design of a Bayesian adaptive clinical trial of tranexamic acid in severely injured children

John M. VanBuren / T. Charles Casper / Daniel K. Nishijima / Nathan Kuppermann / Roger J. Lewis / J. Michael Dean / Anna McGlothlin / For the TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN)

Trials, Vol 22, Iss 1, Pp 1-

2021 Volume 11

Abstract: Abstract Background Trauma is the leading cause of death and disability in children in the USA. Tranexamic acid (TXA) reduces the blood transfusion requirements in adults and children during surgery. Several studies have evaluated TXA in adults with ... ...

Abstract	Abstract Background Trauma is the leading cause of death and disability in children in the USA. Tranexamic acid (TXA) reduces the blood transfusion requirements in adults and children during surgery. Several studies have evaluated TXA in adults with hemorrhagic trauma, but no randomized controlled trials have occurred in children with trauma. We propose a Bayesian adaptive clinical trial to investigate TXA in children with brain and/or torso hemorrhagic trauma. Methods/design We designed a double-blind, Bayesian adaptive clinical trial that will enroll up to 2000 patients. We extend the traditional E max dose-response model to incorporate a hierarchical structure so multiple doses of TXA can be evaluated in different injury populations (isolated head injury, isolated torso injury, or both head and torso injury). Up to 3 doses of TXA (15 mg/kg, 30 mg/kg, and 45 mg/kg bolus doses) will be compared to placebo. Equal allocation between placebo, 15 mg/kg, and 30 mg/kg will be used for an initial period within each injury group. Depending on the dose-response curve, the 45 mg/kg arm may open in an injury group if there is a trend towards increasing efficacy based on the observed relationship using the data from the lower doses. Response-adaptive randomization allows each injury group to differ in allocation proportions of TXA so an optimal dose can be identified for each injury group. Frequent interim stopping periods are included to evaluate efficacy and futility. The statistical design is evaluated through extensive simulations to determine the operating characteristics in several plausible scenarios. This trial achieves adequate power in each injury group. Discussion This trial design evaluating TXA in pediatric hemorrhagic trauma allows for three separate injury populations to be analyzed and compared within a single study framework. Individual conclusions regarding optimal dosing of TXA can be made within each injury group. Identifying the optimal dose of TXA, if any, for various injury types in childhood may reduce death and disability.
Keywords	Bayesian statistics ; Tranexamic acid ; Pediatrics ; Adaptive clinical trial design ; Response-adaptive randomization ; Dose-response ; Medicine (General) ; R5-920
Subject code	610 ; 310
Language	English
Publishing date	2021-11-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Approaches for enhancing the informativeness and quality of clinical trials

Karen Lane / Marisha E. Palm / Eve Marion / Marie T. Kay / Dixie Thompson / Mary Stroud / Helen Boyle / Shannon Hillery / Angeline Nanni / Meghan Hildreth / Sarah Nelson / Jeri S. Burr / Terri Edwards / Lori Poole / Salina P. Waddy / Sarah E. Dunsmore / Paul Harris / Consuelo Wilkins / Gordon R. Bernard /

J. Michael Dean / Jamie Dwyer / Daniel K. Benjamin / Harry P. Selker / Daniel F. Hanley / Daniel E. Ford

Journal of Clinical and Translational Science, Vol

Innovations and principles for implementing multicenter trials from the Trial Innovation Network

2023 Volume 7

Abstract: One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but ...

Abstract	One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
Keywords	Multicenter trials ; informative trials ; Trial Innovation Network ; study planning ; clinical trial budgets ; clinical trial resources ; Medicine ; R
Subject code	650
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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Article ; Online: Decentralized clinical trials in the trial innovation network

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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Article ; Online: Lower respiratory tract infections in children requiring mechanical ventilation

Alexandra Tsitsiklis, PhD / Christina M Osborne, MD / Jack Kamm, PhD / Kayla Williamson, MS / Katrina Kalantar, PhD / Gytis Dudas, PhD / Saharai Caldera, BA / Amy Lyden, BA / Michelle Tan, BS / Norma Neff, PhD / Victoria Soesanto, BS / J Kirk Harris, PhD / Lilliam Ambroggio, PhD / Aline B Maddux, MD / Todd C Carpenter, MD / Ron W Reeder, PhD / Chris Locandro, MS / Eric A F Simões, ProfMD / Matthew K Leroue, MD /

Mark W Hall, ProfMD / Athena F Zuppa, ProfMD / Joseph Carcillo, ProfMD / Kathleen L Meert, ProfMD / Anil Sapru, ProfMD / Murray M Pollack, ProfMD / Patrick S McQuillen, ProfMD / Daniel A Notterman, ProfMD / J Michael Dean, ProfMD / Matt S Zinter, MD / Brandie D Wagner, PhD / Joseph L DeRisi, ProfPhD / Peter M Mourani, ProfMD / Charles R Langelier, MDPhD

The Lancet Microbe, Vol 3, Iss 4, Pp e284-e

a multicentre prospective surveillance study incorporating airway metagenomics

2022 Volume 293

Abstract: Summary: Background: Lower respiratory tract infections (LRTI) are a leading cause of critical illness and mortality in mechanically ventilated children; however, the pathogenic microbes frequently remain unknown. We combined traditional diagnostics with ...

Abstract	Summary: Background: Lower respiratory tract infections (LRTI) are a leading cause of critical illness and mortality in mechanically ventilated children; however, the pathogenic microbes frequently remain unknown. We combined traditional diagnostics with metagenomic next generation sequencing (mNGS) to evaluate the cause of LRTI in critically ill children. Methods: We conducted a prospective, multicentre cohort study of critically ill children aged 31 days to 17 years with respiratory failure requiring mechanical ventilation (>72 h) in the USA. By combining bacterial culture and upper respiratory viral PCR testing with mNGS of tracheal aspirate collected from all patients within 24 h of intubation, we determined the prevalence, age distribution, and seasonal variation of viral and bacterial respiratory pathogens detected by either method in children with or without LRTI. Findings: Between Feb 26, 2015, and Dec 31, 2017, of the 514 enrolled patients, 397 were eligible and included in the study (276 children with LRTI and 121 with no evidence of LRTI). A presumptive microbiological cause was identified in 255 (92%) children with LRTI, with respiratory syncytial virus (127 [46%]), Haemophilus influenzae (70 [25%]), and Moraxella catarrhalis (65 [24%]) being most prevalent. mNGS identified uncommon pathogens including Ureaplasma parvum and Bocavirus. Co-detection of viral and bacterial pathogens occurred in 144 (52%) patients. Incidental carriage of potentially pathogenic microbes occurred in 82 (68%) children without LRTI, with rhinovirus (30 [25%]) being most prevalent. Respiratory syncytial virus (p<0·0001), H influenzae (p=0·0006), and M catarrhalis (p=0·0002) were most common in children younger than 5 years. Viral and bacterial LRTI occurred predominantly during winter months. Interpretation: These findings demonstrate that respiratory syncytial virus, H influenzae, and M catarrhalis contribute disproportionately to severe paediatric LRTI, co-infections are common, and incidental carriage of potentially ...
Keywords	Medicine (General) ; R5-920 ; Microbiology ; QR1-502
Subject code	610
Language	English
Publishing date	2022-04-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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