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Article ; Online: Pediatric Trials Network

Amy Corneli / Brian Perry / Daniel K. Benjamin, Jr. / Kanecia O. Zimmerman

Contemporary Clinical Trials Communications, Vol 22, Iss , Pp 100792- (2021)

Stakeholder views on thanking families and providing study findings on pragmatic pediatric clinical research

2021

Abstract: We conducted formative research using in-depth interviews to identify preferences for and anticipated responses to receiving thank you notes and lay summaries of aggregate results among caregivers and adolescent participants of pragmatic pediatric ... ...

Abstract	We conducted formative research using in-depth interviews to identify preferences for and anticipated responses to receiving thank you notes and lay summaries of aggregate results among caregivers and adolescent participants of pragmatic pediatric studies conducted by the National Institute of Health-sponsored Pediatric Trials Network. We analyzed the data using qualitative thematic analysis. Nearly all participants said receiving a thank you note would make them feel valued, appreciated, and proud because they contributed to science. Similarly, nearly all participants said that receiving a lay summary of research results would make them aware of their role in improving the lives of children, feel like they are an active partner in research, and believe that researchers want to keep them informed. Participants also said that receiving a thank you note or lay summary may motivate them to participate in future research. Providing thank you notes as part of study participation should become a standard clinical trial practice, similar to the practice of providing lay summaries.
Keywords	Lay summary ; Clinical trials ; Pediatric trials network ; Medicine (General) ; R5-920
Language	English
Publishing date	2021-06-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia

Jason E. Lang / Chi D. Hornik / Karen Martz / Juliana Jacangelo / Ravinder Anand / Rachel Greenberg / Christoph Hornik / Kanecia Zimmerman / P. Brian Smith / Daniel K. Benjamin / Matthew Laughon

Contemporary Clinical Trials Communications, Vol 30, Iss , Pp 101025- (2022)

Rationale and methods of a phase II randomized trial

2022

Abstract: Bronchopulmonary dysplasia (BPD) is a disease of chronic respiratory insufficiency stemming from premature birth and iatrogenic lung injury leading to alveolar simplification, impaired alveolar-capillary development, interstitial fibrosis, and often ... ...

Abstract	Bronchopulmonary dysplasia (BPD) is a disease of chronic respiratory insufficiency stemming from premature birth and iatrogenic lung injury leading to alveolar simplification, impaired alveolar-capillary development, interstitial fibrosis, and often pulmonary hypertension. BPD is the most common pulmonary sequela of prematurity and is often fatal; however, there remains no FDA-approved therapies to treat or prevent BPD. Sildenafil is increasingly used off-label in premature infants despite scant safety and efficacy data. Sildenafil reduces lung injury and preserves normal vasculature in preclinical models, and improves outcomes in children with pulmonary hypertension, and thus is a promising candidate for BPD. Following phase I studies, we developed the phase II SIL02 trial to describe the safety, pharmacokinetics and preliminary effectiveness of intravenous and enteral sildenafil in premature infants at risk for BPD. SIL02 is a randomized, double-blind, placebo-controlled, 3-cohort, sequential dose-escalating trial of enteral or intravenous (IV) sildenafil dosed every 8 h for up to 34 days. The target IV doses were 0.125, 0.5 and 1 mg/kg/dose in cohorts 1, 2 and 3, respectively; while the enteral doses will be double the IV doses. Eligible infants must be < 29 weeks' gestation at birth and requiring respiratory support at 7–28 days' postnatal age. Adverse events and preliminary effectiveness will be compared by treatment group. Using the final population PK model, empirical Bayesian estimates will be generated for each patient. Preliminary effectiveness will be measured by the incidence of moderate to severe BPD or death at 36 weeks and change in the BPD risk estimation.
Keywords	Sildenafil ; Bronchopulmonary dysplasia ; Prematurity ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2022-12-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Developing lay summaries and thank you notes in paediatric pragmatic clinical trials

Kanecia O. Zimmerman / Brian Perry / Emily Hanlen‐Rosado / Adora Nsonwu / Morgan D. Lane / Daniel K. Benjamin / Mara Becker / Amy Corneli / Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee

Health Expectations, Vol 25, Iss 3, Pp 1029-

2022 Volume 1037

Abstract: Abstract Introduction Better transparency of research results and participant engagement may help address poor participant accrual in paediatric clinical research. We conducted formative research to assess the acceptability of lay summaries and thank you ...

Abstract	Abstract Introduction Better transparency of research results and participant engagement may help address poor participant accrual in paediatric clinical research. We conducted formative research to assess the acceptability of lay summaries and thank you notes, as well as to refine and expand guidance on participant and family engagement in Pediatric Trials Network's (PTN) pragmatic paediatric clinical research. Methods Informed by draft PTN guidance, we conducted in‐depth qualitative interviews with adolescent clinical trial participants and caregivers of paediatric participants in four trials conducted by PTN across eight sites. Participants were shown multiple versions of mock lay summaries and thank you notes and asked questions on their preferences for content and layout, and on trial communications. We used applied thematic analysis to analyse the data. Results We interviewed 27 individuals engaged in PTN research: 24 caregivers and 3 adolescents. During a trial, participants want regular updates on study progress, reminders of the study purpose and reassurances of data confidentiality. After the trial, participants want to learn the aggregated results, particularly medication effectiveness. Participants reported that lay summaries should include a review of the study's purpose, methods and length, and that they expect to learn individual‐level results. Participants stated that thank you notes must be of sufficient length to be meaningful. Conclusions This is the first study to describe stakeholder preferences for thank you note content and layout. Using these findings, we finalized PTN's trial communication guidance for use in future PTN trials. Research is needed to determine the effect of lay summaries and thank you notes on improving public transparency regarding clinical trials and paediatric trial recruitment and completion. Patient or Public Contribution By design, stakeholders (adolescent trial participants and caregivers of pediatric trial participants) contributed to PTN's guidance on the content ...
Keywords	clinical trials ; formative research ; lay summaries ; paediatrics ; Medicine (General) ; R5-920 ; Public aspects of medicine ; RA1-1270
Subject code	410 ; 306
Language	English
Publishing date	2022-06-01T00:00:00Z
Publisher	Wiley
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: 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: Direct-to-participant recruitment of mothers and infants

Stefany Olague / Helen Boyle / Imtiaz Ahmed / Basharat Buchh / Giang Sinh T. Truong / Brent Reyburn / Clarissa DeLeon / Grace C. Lin / Kaashif A. Ahmad / Barbara Carr / Meghali Singhal / Melissa Althouse / Raymond Castro / Anthony Rudine / Evelyn Rider / Melissa L. Macomber-Estill / Bradley Doles / Jenelle F. Ferry / Hector Pierantoni /

Savannah Sutherland / Reese H. Clark / Courtney K. Blackwell / P. Brian Smith / Daniel K. Benjamin, Jr. / Rachel G. Greenberg

Contemporary Clinical Trials Communications, Vol 38, Iss , Pp 101261- (2024)

A strategic approach during challenging pandemic times

2024

Abstract: Under traditional circumstances, most clinical trials rely on in-person operations to identify, recruit, and enroll study participants and to complete study-related visits. During unusual circumstances, such as the COVID-19 pandemic, the typical clinical ...

Abstract	Under traditional circumstances, most clinical trials rely on in-person operations to identify, recruit, and enroll study participants and to complete study-related visits. During unusual circumstances, such as the COVID-19 pandemic, the typical clinical trial model is challenged and forced to explore alternative approaches to implementing study recruitment, participant enrollment, and data collection strategies. One such alternative is a direct-to-participant approach which leverages electronic resources and relevant technological devices (e.g., smart phones) available to researchers and patients. This approach functions under the assumption that a participant has access to a device that connects to the internet such as a smart phone, tablet, or computer. Researchers are then able to transition a typical paper-based, in-person model to an electronic-based, siteless, remote study. This article describes the challenges clinicians and researchers faced when implementing a direct-to-participant study approach during the COVID-19 pandemic. The lessons learned during this study of infant populations could help increase efficiency of future trials, specifically, by lessening the burden on participants and clinicians as well as streamlining the process for enrollment and data collection. While direct-to-adult participant recruitment is not a novel approach, our findings suggest that studies attempting to recruit the infant population may benefit from such a direct-to-participant approach.
Keywords	Direct-to-participant ; Neonate ; Newborn ; COVID-19 ; Medicine (General) ; R5-920
Subject code	420
Language	English
Publishing date	2024-04-01T00:00:00Z
Publisher	Elsevier
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: A collaborative, academic approach to optimizing the national clinical research infrastructure

Gordon R. Bernard / Paul A. Harris / Jill M. Pulley / Daniel K. Benjamin / Jonathan Michael Dean / Daniel E. Ford / Daniel F. Hanley / Harry P. Selker / Consuelo H. Wilkins

Journal of Clinical and Translational Science, Vol 2, Pp 187-

The first year of the Trial Innovation Network

2018 Volume 192

Abstract: Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science—sponsored Clinical and Translational Science Award (CTSA) program is able to address such ... ...

Abstract	Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science—sponsored Clinical and Translational Science Award (CTSA) program is able to address such inefficiencies. The Trial Innovation Network (TIN) is a collaborative initiative with the CTSA program and other National Institutes of Health (NIH) Institutes and Centers that addresses critical roadblocks to accelerate the translation of novel interventions to clinical practice. The TIN’s mission is to execute high-quality trials in a quick, cost-efficient manner. The TIN awardees are composed of 3 Trial Innovation Centers, the Recruitment Innovation Center, and the individual CTSA institutions that have identified TIN Liaison units. The TIN has launched a national scale single (central) Institutional Review Board system, master contracting agreements, quality-by-design approaches, novel recruitment support methods, and applies evidence-based strategies to recruitment and patient engagement. The TIN has received 113 submissions from 39 different CTSA institutions and 8 non-CTSA Institutions, with projects associated with 12 different NIH Institutes and Centers across a wide range of clinical/disease areas. Already more than 150 unique health systems/organizations are involved as sites in TIN-related multisite studies. The TIN will begin to capture data and metrics that quantify increased efficiency and quality improvement during operations.
Keywords	Trial Innovation Network ; clinical trials ; CTSA program ; multisite clinical research ; innovation ; Medicine ; R
Subject code	027
Language	English
Publishing date	2018-08-01T00:00:00Z
Publisher	Cambridge University Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials

Rachel G. Greenberg / Amy Corneli / John Bradley / John Farley / Hasan S. Jafri / Li Lin / Sumathi Nambiar / Gary J. Noel / Chris Wheeler / Rosemary Tiernan / P. Brian Smith / Jamie Roberts / Daniel K. Benjamin, Jr.

Contemporary Clinical Trials Communications, Vol 9, Iss C, Pp 7-

Findings from the Clinical Trials Transformation Initiative

2018 Volume 12

Abstract: Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to ... ...

Abstract	Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recruitment of pediatric patients, but little is known regarding the specific barriers that limit pediatric providers from participating in and referring their patients to clinical trials. We conducted an online survey of pediatric providers from a wide variety of practice types across the United States to evaluate their attitudes and awareness of pediatric clinical trials. Using a 4-point Likert scale, providers described their perception of potential barriers to their practice serving as a site for pediatric clinical trials. Of the 136 providers surveyed, 52/136 (38%) had previously referred a pediatric patient to a trial, and only 17/136 (12%) had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.
Keywords	Pediatric clinical trials ; Enrollment ; Provider referral ; Practitioner referral ; ABDD ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2018-03-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials

Amy Corneli / Chris Wheeler / John Bradley / Breck Gamel / Sumathi Nambiar / Gary J. Noel / Li Lin / Jamie N. Roberts / Daniel K. Benjamin, Jr.

Contemporary Clinical Trials Communications, Vol 9, Iss C, Pp 115-

Findings from CTTI's survey of investigators

2018 Volume 120

Abstract: An urgent need exists to develop new antibacterial drugs for children. We conducted research with investigators of pediatric antibacterial drug trials to identify facilitators and barriers in the conduct of these trials. Seventy-three investigators ... ...

Abstract	An urgent need exists to develop new antibacterial drugs for children. We conducted research with investigators of pediatric antibacterial drug trials to identify facilitators and barriers in the conduct of these trials. Seventy-three investigators completed an online survey assessing the importance of 15 facilitators (grouped in 5 topical categories) and the severity of 36 barriers (grouped in 6 topical categories) to implementing pediatric antibacterial drug trials. Analysis focused on the identification of key factors that facilitate the successful implementation of pediatric antibacterial drug trials and the key barriers to implementation. Almost all investigators identified two factors as very important facilitators: having site personnel for enrollment and having adequate funding. Other top factors were related to staffing. Among the barriers, factors related to parent concerns and consent were prominent, particularly obtaining parental consent when there was disagreement between parents, concerns about the number of blood draws, and concerns about the number of invasive procedures. Having overly narrow eligibility criteria was also identified as a major barrier. The survey findings suggest three areas in which to focus efforts to help facilitate ongoing drug development: (1) improving engagement with parents of children who may be eligible to enroll in a pediatric antibacterial drug trial, (2) broadening inclusion criteria to allow more participants to enroll, and (3) ensuring adequate staffing and establishing sustainable financial strategies, such as funding pediatric trial networks. The pediatric antibacterial drug trials enterprise is likely to benefit from focused efforts by all stakeholders to remove barriers and enhance facilitation.
Keywords	Pediatric antibacterial drug trials ; Pediatric clinical research ; Facilitators ; Barriers ; Medicine (General) ; R5-920
Subject code	360
Language	English
Publishing date	2018-03-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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