Browsing by Subject "Best practices"

Now showing 1 - 5 of 5
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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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    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 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.