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Article ; Online: The power of public–private partnership in medical technology innovation

Michael E. Singer / Dallas C. Hack / Daniel F. Hanley

Journal of Clinical and Translational Science, Vol

Lessons from the development of FDA-cleared medical devices for assessment of concussion

2022 Volume 6

Abstract: Given the convergence of the long and challenging development path for medical devices with the need for diagnostic capabilities for mild traumatic brain injury (mTBI/concussion), the effective role of public–private partnership (PPP) can be demonstrated ...

Abstract	Given the convergence of the long and challenging development path for medical devices with the need for diagnostic capabilities for mild traumatic brain injury (mTBI/concussion), the effective role of public–private partnership (PPP) can be demonstrated to yield Food and Drug Administration (FDA) clearances and innovative product introductions. An overview of the mTBI problem and landscape was performed. A detailed situation analysis of an example of a PPP yielding an innovative product was further demonstrated. The example of PPP has led to multiple FDA clearances and product introductions in the TBI diagnostic product category where there was an urgent military and public need. Important lessons included defining the primary public and military health objective for new product introduction, the importance of the government–academia–industry PPP triad with a “collaboration towards solutions” Quality-by-Design (QbD) mindset to assure clinical validity with regulatory compliance, the development of device comparators and integration of measurements into a robust, evidence-based statistical and FDA pathway, and the utility of top-down, flexible, practical action while operating within governmental guidelines and patient safety.
Keywords	Medical technology ; concussion ; medical devices ; traumatic brain injury (TBI) ; medical technology innovation ; medical device development ; innovation ; development ; 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: 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: PItcHPERFeCT

John Muschelli / Elizabeth M. Sweeney / Natalie L. Ullman / Paul Vespa / Daniel F. Hanley / Ciprian M. Crainiceanu

NeuroImage: Clinical, Vol 14, Iss C, Pp 379-

Primary Intracranial Hemorrhage Probability Estimation using Random Forests on CT

2017 Volume 390

Abstract: Introduction: Intracerebral hemorrhage (ICH), where a blood vessel ruptures into areas of the brain, accounts for approximately 10–15% of all strokes. X-ray computed tomography (CT) scanning is largely used to assess the location and volume of these ... ...

Abstract	Introduction: Intracerebral hemorrhage (ICH), where a blood vessel ruptures into areas of the brain, accounts for approximately 10–15% of all strokes. X-ray computed tomography (CT) scanning is largely used to assess the location and volume of these hemorrhages. Manual segmentation of the CT scan using planimetry by an expert reader is the gold standard for volume estimation, but is time-consuming and has within- and across-reader variability. We propose a fully automated segmentation approach using a random forest algorithm with features extracted from X-ray computed tomography (CT) scans. Methods: The Minimally Invasive Surgery plus rt-PA in ICH Evacuation (MISTIE) trial was a multi-site Phase II clinical trial that tested the safety of hemorrhage removal using recombinant-tissue plasminogen activator (rt-PA). For this analysis, we use 112 baseline CT scans from patients enrolled in the MISTE trial, one CT scan per patient. ICH was manually segmented on these CT scans by expert readers. We derived a set of imaging predictors from each scan. Using 10 randomly-selected scans, we used a first-pass voxel selection procedure based on quantiles of a set of predictors and then built 4 models estimating the voxel-level probability of ICH. The models used were: 1) logistic regression, 2) logistic regression with a penalty on the model parameters using LASSO, 3) a generalized additive model (GAM) and 4) a random forest classifier. The remaining 102 scans were used for model validation.For each validation scan, the model predicted the probability of ICH at each voxel. These voxel-level probabilities were then thresholded to produce binary segmentations of the hemorrhage. These masks were compared to the manual segmentations using the Dice Similarity Index (DSI) and the correlation of hemorrhage volume of between the two segmentations. We tested equality of median DSI using the Kruskal-Wallis test across the 4 models. We tested equality of the median DSI from sets of 2 models using a Wilcoxon signed-rank test. Results: ...
Keywords	CT ; ICH segmentation ; Intracerebral hemorrhage ; Stroke ; Computer applications to medicine. Medical informatics ; R858-859.7 ; Neurology. Diseases of the nervous system ; RC346-429
Subject code	310
Language	English
Publishing date	2017-01-01T00:00:00Z
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: 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: Leukocyte dynamics after intracerebral hemorrhage in a living patient reveal rapid adaptations to tissue milieu

Brittany A. Goods / Michael H. Askenase / Erica Markarian / Hannah E. Beatty / Riley S. Drake / Ira Fleming / Jonathan H. DeLong / Naomi H. Philip / Charles C. Matouk / Issam A. Awad / Mario Zuccarello / Daniel F. Hanley / J. Christopher Love / Alex K. Shalek / Lauren H. Sansing / the ICHseq Investigators

JCI Insight, Vol 6, Iss

2021 Volume 6

Abstract: Intracerebral hemorrhage (ICH) is a devastating form of stroke with a high mortality rate and few treatment options. Discovery of therapeutic interventions has been slow given the challenges associated with studying acute injury in the human brain. ... ...

Abstract	Intracerebral hemorrhage (ICH) is a devastating form of stroke with a high mortality rate and few treatment options. Discovery of therapeutic interventions has been slow given the challenges associated with studying acute injury in the human brain. Inflammation induced by exposure of brain tissue to blood appears to be a major part of brain tissue injury. Here, we longitudinally profiled blood and cerebral hematoma effluent from a patient enrolled in the Minimally Invasive Surgery with Thrombolysis in Intracerebral Hemorrhage Evacuation trial, offering a rare window into the local and systemic immune responses to acute brain injury. Using single-cell RNA-Seq (scRNA-Seq), this is the first report to our knowledge that characterized the local cellular response during ICH in the brain of a living patient at single-cell resolution. Our analysis revealed shifts in the activation states of myeloid and T cells in the brain over time, suggesting that leukocyte responses are dynamically reshaped by the hematoma microenvironment. Interestingly, the patient had an asymptomatic rebleed that our transcriptional data indicated occurred prior to detection by CT scan. This case highlights the rapid immune dynamics in the brain after ICH and suggests that sensitive methods such as scRNA-Seq would enable greater understanding of complex intracerebral events.
Keywords	Immunology ; Neuroscience ; Medicine ; R
Subject code	616
Language	English
Publishing date	2021-03-01T00:00:00Z
Publisher	American Society for Clinical investigation
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: Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19

Leon Di Stefano / Elizabeth L Ogburn / Malathi Ram / Daniel O Scharfstein / Tianjing Li / Preeti Khanal / Sheriza N Baksh / Nichol McBee / Joshua Gruber / Marianne R Gildea / Megan R Clark / Neil A Goldenberg / Yussef Bennani / Samuel M Brown / Whitney R Buckel / Meredith E Clement / Mark J Mulligan / Jane A O'Halloran / Adriana M Rauseo /

Wesley H Self / Matthew W Semler / Todd Seto / Jason E Stout / Robert J Ulrich / Jennifer Victory / Barbara E Bierer / Daniel F Hanley / Daniel Freilich / Pandemic Response COVID-19 Research Collaboration Platform for HCQ/CQ Pooled Analyses

PLoS ONE, Vol 17, Iss 9, p e

An individual participant data meta-analysis.

2022 Volume 0273526

Abstract: Background Results from observational studies and randomized clinical trials (RCTs) have led to the consensus that hydroxychloroquine (HCQ) and chloroquine (CQ) are not effective for COVID-19 prevention or treatment. Pooling individual participant data, ... ...

Abstract	Background Results from observational studies and randomized clinical trials (RCTs) have led to the consensus that hydroxychloroquine (HCQ) and chloroquine (CQ) are not effective for COVID-19 prevention or treatment. Pooling individual participant data, including unanalyzed data from trials terminated early, enables more detailed investigation of the efficacy and safety of HCQ/CQ among subgroups of hospitalized patients. Methods We searched ClinicalTrials.gov in May and June 2020 for US-based RCTs evaluating HCQ/CQ in hospitalized COVID-19 patients in which the outcomes defined in this study were recorded or could be extrapolated. The primary outcome was a 7-point ordinal scale measured between day 28 and 35 post enrollment; comparisons used proportional odds ratios. Harmonized de-identified data were collected via a common template spreadsheet sent to each principal investigator. The data were analyzed by fitting a prespecified Bayesian ordinal regression model and standardizing the resulting predictions. Results Eight of 19 trials met eligibility criteria and agreed to participate. Patient-level data were available from 770 participants (412 HCQ/CQ vs 358 control). Baseline characteristics were similar between groups. We did not find evidence of a difference in COVID-19 ordinal scores between days 28 and 35 post-enrollment in the pooled patient population (odds ratio, 0.97; 95% credible interval, 0.76-1.24; higher favors HCQ/CQ), and found no convincing evidence of meaningful treatment effect heterogeneity among prespecified subgroups. Adverse event and serious adverse event rates were numerically higher with HCQ/CQ vs control (0.39 vs 0.29 and 0.13 vs 0.09 per patient, respectively). Conclusions The findings of this individual participant data meta-analysis reinforce those of individual RCTs that HCQ/CQ is not efficacious for treatment of COVID-19 in hospitalized patients.
Keywords	Medicine ; R ; Science ; Q
Subject code	310
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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