Browsing by Subject "Best practices"

Now showing 1 - 9 of 9
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    Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis
    (Wiley, 2019-03) Regev, Arie; Palmer, Melissa; Avigan, Mark I.; Dimick‐Santos, Lara; Treem, William R.; Marcinak, John F.; Seekins, Daniel; Krishna, Gopal; Anania, Frank A.; Freston, James W.; Lewis, James H.; Sanyal, Arun J.; Chalasani, Naga; Gastroenterology, IU School of Medicine
    BACKGROUND: The last decade has seen a rapid growth in the number of clinical trials enrolling patients with nonalcoholic fatty liver disease and nonalcoholic steatohepatitis (NASH). Due to the underlying chronic liver disease, patients with NASH often require different approaches to the assessment and management of suspected drug-induced liver injury (DILI) compared to patients with healthy livers. However, currently no regulatory guidelines or position papers systematically address best practices pertaining to DILI in NASH clinical trials. AIMS: This publication focuses on best practices concerning the detection, monitoring, diagnosis and management of suspected acute DILI during clinical trials in patients with NASH. METHODS: This is one of several papers developed by the IQ DILI Initiative, comprised of members from 15 pharmaceutical companies, in collaboration with DILI experts from academia and regulatory agencies. This paper is based on extensive literature review, and discussions between industry members with expertise in drug safety and DILI experts from outside industry to achieve consensus on common questions related to this topic. RESULTS: Recommended best practices are outlined pertaining to hepatic inclusion and exclusion criteria, monitoring of liver tests, DILI detection, approach to a suspected DILI signal, causality assessment and hepatic discontinuation rules. CONCLUSIONS: This paper provides a framework for the approach to assessment and management of suspected acute DILI during clinical trials in patients with NASH.
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    Considerations and recommendations from the ISMRM diffusion study group for preclinical diffusion MRI: Part 1: In vivo small-animal imaging
    (Wiley, 2025) Jelescu, Ileana O.; Grussu, Francesco; Ianus, Andrada; Hansen, Brian; Barrett, Rachel L. C.; Aggarwal, Manisha; Michielse, Stijn; Nasrallah, Fatima; Syeda, Warda; Wang, Nian; Veraart, Jelle; Roebroeck, Alard; Bagdasarian, Andrew F.; Eichner, Cornelius; Sepehrband, Farshid; Zimmermann, Jan; Soustelle, Lucas; Bowman, Christien; Tendler, Benjamin C.; Hertanu, Andreea; Jeurissen, Ben; Verhoye, Marleen; Frydman, Lucio; van de Looij, Yohan; Hike, David; Dunn, Jeff F.; Miller, Karla; Landman, Bennett A.; Shemesh, Noam; Anderson, Adam; McKinnon, Emilie; Farquharson, Shawna; Dell'Acqua, Flavio; Pierpaoli, Carlo; Drobnjak, Ivana; Leemans, Alexander; Harkins, Kevin D.; Descoteaux, Maxime; Xu, Duan; Huang, Hao; Santin, Mathieu D.; Grant, Samuel C.; Obenaus, Andre; Kim, Gene S.; Wu, Dan; Le Bihan, Denis; Blackband, Stephen J.; Ciobanu, Luisa; Fieremans, Els; Bai, Ruiliang; Leergaard, Trygve B.; Zhang, Jiangyang; Dyrby, Tim B.; Johnson, G. Allan; Cohen-Adad, Julien; Budde, Matthew D.; Schilling, Kurt G.; Neurology, School of Medicine
    Small-animal diffusion MRI (dMRI) has been used for methodological development and validation, characterizing the biological basis of diffusion phenomena, and comparative anatomy. The steps from animal setup and monitoring, to acquisition, analysis, and interpretation are complex, with many decisions that may ultimately affect what questions can be answered using the resultant data. This work aims to present selected considerations and recommendations from the diffusion community on best practices for preclinical dMRI of in vivo animals. We describe the general considerations and foundational knowledge that must be considered when designing experiments. We briefly describe differences in animal species and disease models and discuss why some may be more or less appropriate for different studies. We, then, give recommendations for in vivo acquisition protocols, including decisions on hardware, animal preparation, and imaging sequences, followed by advice for data processing including preprocessing, model-fitting, and tractography. Finally, we provide an online resource that lists publicly available preclinical dMRI datasets and software packages to promote responsible and reproducible research. In each section, we attempt to provide guides and recommendations, but also highlight areas for which no guidelines exist (and why), and where future work should focus. Although we mainly cover the central nervous system (on which most preclinical dMRI studies are focused), we also provide, where possible and applicable, recommendations for other organs of interest. An overarching goal is to enhance the rigor and reproducibility of small animal dMRI acquisitions and analyses, and thereby advance biomedical knowledge.
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    Considerations and recommendations from the ISMRM diffusion study group for preclinical diffusion MRI: Part 2-Ex vivo imaging: Added value and acquisition
    (Wiley, 2025) Schilling, Kurt G.; Grussu, Francesco; Ianus, Andrada; Hansen, Brian; Howard, Amy F. D.; Barrett, Rachel L. C.; Aggarwal, Manisha; Michielse, Stijn; Nasrallah, Fatima; Syeda, Warda; Wang, Nian; Veraart, Jelle; Roebroeck, Alard; Bagdasarian, Andrew F.; Eichner, Cornelius; Sepehrband, Farshid; Zimmermann, Jan; Soustelle, Lucas; Bowman, Christien; Tendler, Benjamin C.; Hertanu, Andreea; Jeurissen, Ben; Verhoye, Marleen; Frydman, Lucio; van de Looij, Yohan; Hike, David; Dunn, Jeff F.; Miller, Karla; Landman, Bennett A.; Shemesh, Noam; Anderson, Adam; McKinnon, Emilie; Farquharson, Shawna; Dell'Acqua, Flavio; Pierpaoli, Carlo; Drobnjak, Ivana; Leemans, Alexander; Harkins, Kevin D.; Descoteaux, Maxime; Xu, Duan; Huang, Hao; Santin, Mathieu D.; Grant, Samuel C.; Obenaus, Andre; Kim, Gene S.; Wu, Dan; Le Bihan, Denis; Blackband, Stephen J.; Ciobanu, Luisa; Fieremans, Els; Bai, Ruiliang; Leergaard, Trygve B.; Zhang, Jiangyang; Dyrby, Tim B.; Johnson, G. Allan; Cohen-Adad, Julien; Budde, Matthew D.; Jelescu, Ileana O.; Neurology, School of Medicine
    The value of preclinical diffusion MRI (dMRI) is substantial. While dMRI enables in vivo non-invasive characterization of tissue, ex vivo dMRI is increasingly being used to probe tissue microstructure and brain connectivity. Ex vivo dMRI has several experimental advantages including higher SNR and spatial resolution compared to in vivo studies, and enabling more advanced diffusion contrasts for improved microstructure and connectivity characterization. Another major advantage of ex vivo dMRI is the direct comparison with histological data, as a crucial methodological validation. However, there are a number of considerations that must be made when performing ex vivo experiments. The steps from tissue preparation, image acquisition and processing, and interpretation of results are complex, with many decisions that not only differ dramatically from in vivo imaging of small animals, but ultimately affect what questions can be answered using the data. This work represents "Part 2" of a three-part series of recommendations and considerations for preclinical dMRI. We describe best practices for dMRI of ex vivo tissue, with a focus on the value that ex vivo imaging adds to the field of dMRI and considerations in ex vivo image acquisition. We first give general considerations and foundational knowledge that must be considered when designing experiments. We briefly describe differences in specimens and models and discuss why some may be more or less appropriate for different studies. We then give guidelines for ex vivo protocols, including tissue fixation, sample preparation, and MR scanning. In each section, we attempt to provide guidelines and recommendations, but also highlight areas for which no guidelines exist (and why), and where future work should lie. An overarching goal herein is to enhance the rigor and reproducibility of ex vivo dMRI acquisitions and analyses, and thereby advance biomedical knowledge.
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    Considerations and recommendations from the ISMRM Diffusion Study Group for preclinical diffusion MRI: Part 3-Ex vivo imaging: Data processing, comparisons with microscopy, and tractography
    (Wiley, 2025) Schilling, Kurt G.; Howard, Amy F. D.; Grussu, Francesco; Ianus, Andrada; Hansen, Brian; Barrett, Rachel L. C.; Aggarwal, Manisha; Michielse, Stijn; Nasrallah, Fatima; Syeda, Warda; Wang, Nian; Veraart, Jelle; Roebroeck, Alard; Bagdasarian, Andrew F.; Eichner, Cornelius; Sepehrband, Farshid; Zimmermann, Jan; Soustelle, Lucas; Bowman, Christien; Tendler, Benjamin C.; Hertanu, Andreea; Jeurissen, Ben; Verhoye, Marleen; Frydman, Lucio; van de Looij, Yohan; Hike, David; Dunn, Jeff F.; Miller, Karla; Landman, Bennett A.; Shemesh, Noam; Anderson, Adam; McKinnon, Emilie; Farquharson, Shawna; Dell'Acqua, Flavio; Pierpaoli, Carlo; Drobnjak, Ivana; Leemans, Alexander; Harkins, Kevin D.; Descoteaux, Maxime; Xu, Duan; Huang, Hao; Santin, Mathieu D.; Grant, Samuel C.; Obenaus, Andre; Kim, Gene S.; Wu, Dan; Le Bihan, Denis; Blackband, Stephen J.; Ciobanu, Luisa; Fieremans, Els; Bai, Ruiliang; Leergaard, Trygve B.; Zhang, Jiangyang; Dyrby, Tim B.; Johnson, G. Allan; Cohen-Adad, Julien; Budde, Matthew D.; Jelescu, Ileana O.; Neurology, School of Medicine
    Preclinical diffusion MRI (dMRI) has proven value in methods development and validation, characterizing the biological basis of diffusion phenomena, and comparative anatomy. While dMRI enables in vivo non-invasive characterization of tissue, ex vivo dMRI is increasingly being used to probe tissue microstructure and brain connectivity. Ex vivo dMRI has several experimental advantages that facilitate high spatial resolution and high SNR images, cutting-edge diffusion contrasts, and direct comparison with histological data as a methodological validation. However, there are a number of considerations that must be made when performing ex vivo experiments. The steps from tissue preparation, image acquisition and processing, and interpretation of results are complex, with many decisions that not only differ dramatically from in vivo imaging of small animals, but ultimately affect what questions can be answered using the data. This work concludes a three-part series of recommendations and considerations for preclinical dMRI. Herein, we describe best practices for dMRI of ex vivo tissue, with a focus on image pre-processing, data processing, and comparisons with microscopy. In each section, we attempt to provide guidelines and recommendations but also highlight areas for which no guidelines exist (and why), and where future work should lie. We end by providing guidelines on code sharing and data sharing and point toward open-source software and databases specific to small animal and ex vivo imaging.
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    Developing a Best Practices Plan for Tutorials in a Multi-Library System
    (Taylor and Francis, 2014-07-14) Blevins, Amy E.; Deberg, Jennifer; Childs, Chris
    In 2010, the University of Iowa's library system administration created a task force to conduct a reevaluation of tools and spaces used for video tutorial creation across a multi-library system. Following this effort, a working group was charged with improving documentation and staff awareness of resources for developing video tutorials. The group observed that librarians were often independently creating videos that were variable in quality, lacked consistent branding, and were not often shared with others. This article will describe experiences at the Hardin Library for the Health Sciences at the University of Iowa in selecting video tutorial software, and striving to establish a more structured process, including team-developed guidelines, for tutorial creation in a multi-library system. Project limitations and areas for future work will also be presented.
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    Development of Written Materials for Participants in an Alzheimer's Disease and Related Dementias Screening Trial
    (Sage, 2022-04-12) Head, Katharine J.; Hartsock, Jane A.; Bakas, Tamilyn; Boustani, Malaz A.; Schroeder, Matthew; Fowler, Nicole R.; Communication Studies, School of Liberal Arts
    Given that participants' experiences in clinical trials include a variety of communication touchpoints with clinical trial staff, these communications should be designed in a way that enhances the participant experience by paying attention to the self-determination theoretical concepts of competence, autonomy, and relatedness. In this feature, we argue that clinical trial teams need to consider the importance of how they design their written participant communication materials, and we explain in detail the process our multidisciplinary team took to design written materials for the patient and family caregiver participants in our Alzheimer's disease and related dementias (ADRD) screening trial. This article concludes with suggested guidance and steps for other clinical trial teams.
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    ILL best practices: streamlining & greening
    (2012-11-14) Baich, Tina; Baker, Christine A.; Walker, Karen
    This program will provide ILL practitioners with ideas to help them streamline and green their operations. Key topics to be discussed will include streamlining with technology by using features of WorldCat Resource Sharing, Odyssey standalone, Article Exchange, etc.; streamlining manual workflows within IN-Share and Evergreen libraries and reducing waste in ILL by greening the process.
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    Meeting report of the annual workshop on Principles and Techniques for Improving Preclinical to Clinical Translation in Alzheimer’s Disease Research
    (Wiley, 2023) Sasner, Michael; Territo, Paul R.; Sukoff Rizzo, Stacey J.; Pharmacology and Toxicology, School of Medicine
    Introduction: The second annual 5-day workshop on Principles and Techniques for Improving Preclinical to Clinical Translation in Alzheimer's Disease Research was held October 7-11, 2019, at The Jackson Laboratory in Bar Harbor, Maine, USA, and included didactic lectures and hands-on training. Participants represented a broad range of research across the Alzheimer's disease (AD) field, and varied in career stages from trainees and early stage investigators to established faculty, with attendance from the United States, Europe, and Asia. Methods: In line with the National Institutes of Health (NIH) initiative on rigor and reproducibility, the workshop aimed to address training gaps in preclinical drug screening by providing participants with the skills and knowledge required to perform pharmacokinetic, pharmacodynamics, and preclinical efficacy experiments. Results: This innovative and comprehensive workshop provided training in fundamental skill sets for executing in vivo preclinical translational studies. Discussion: The success of this workship is expected to translate into practical skills that will enable the goals of improving preclinical to clinical translational studies for AD. Highlights: Nearly all preclinical studies in animal models have failed to translate to successful efficacious medicines for Alzheimer's disease (AD) patients. While a wide variety of potential causes of these failures have been proposed,deficiencies in knowledge and best practices for translational research are not being sufficiently addressed by common training practices. Here we present proceedings from an annual NIA-sponsored workshop focused specifically on preclinical testing paradigms for AD translational research in animal models aimed at enabling improved preclinical to clinical translation for AD.
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    Meeting report of the fifth annual workshop on Principles and Techniques for Improving Preclinical to Clinical Translation in Alzheimer's Disease Research
    (Wiley, 2024) Sasner, Michael; Onos, Kristen D.; Territo, Paul R.; Sukoff Rizzo, Stacey J.; Medicine, School of Medicine
    The fifth annual workshop on Principles and Techniques for Improving Preclinical Translation of Alzheimer's Disease Research was held in May 2023 at The Jackson Laboratory in Bar Harbor, Maine, USA. The workshop was established in 2018 to address training gaps in preclinical translational studies for Alzheimer's disease (AD). In addition to providing fundamental knowledge and hands-on skills essential for executing rigorous in vivo studies that are designed to facilitate translation, each year the workshop aims to provide insight on state-of-the-field technological advances and new resources including novel animal models, publicly available datasets, novel biomarkers, and new medical imaging tracers. This innovative and comprehensive workshop continues to deliver training for the greater AD research community in order to provide investigators and trainees with the knowledge and skillsets essential for enabling improved preclinical to clinical translation and accelerate the process of advancing safe and effective therapeutic interventions for AD. HIGHLIGHTS: Translational research is not typically available as a course of study at academic institutions, yet there are fundamental skillsets and knowledge required to enable successful translation from preclinical experiments to clinical efficacy. It is important that there are resources and opportunities available to researchers planning preclinical translational experiments. Here we present proceedings from the fifth annual NIA-sponsored workshop focused on enabling improved preclinical to clinical translation for Alzheimer's disease research that includes didactic lectures on state-of-the-field approaches and hands-on practicums for acquiring essential translational laboratory techniques.