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Katherine Elizabeth Skinner

In this article, we raise questions about how bundling and independence show up in the scholarly publishing industry today, both for large conglomerates and for smaller commercial and nonprofit players. We then contemplate what interdependence might look like and how it might help to transform academic publishing. We end with findings from the Next Generation Library Publishing (NGLP) project (2019-2022) and its Collaborative Frameworks Working Group regarding a set of initial steps that we believe publishers, tools, and service providers might take together towards developing a collective publishing framework for open source, values-aligned tools and services.

Maren Weber ◽  
Nicoletta Sacchi ◽  
Sherry Haun ◽  
Ingrid Tistl ◽  
Stephanie Thompson ◽  

AbstractAccording to the Standards of the World Marrow Donor Association (WMDA) 2020 [1] unrelated stem cell donor registries are responsible for compliance of their donor centres with these Standards. To ensure high stem cell product quality and high standards for safety and satisfaction of voluntary unrelated stem cell donors, we present here guidelines for audits of donor centres (DC) that can be used by new and established donor registries. They have been developed for registries relying on independent national or international DCs for the recruitment and management of Unrelated Donors (UD) for verification typing (VT)/extended tying (ET), work up processes and Hemopoietic Progenitor Cell (HPC) donation. The main goal of these guidelines is to support registries in verifying and auditing their affiliated DCs to ensure they are compliant with the WMDA Standards, as well as WMDA recommendations. We define the general requirements and recommendations for collaboration with the DC and guidelines to manage the UD, step by step from recruitment to follow-up. We also provide a checklist, intended to serve as a resource for auditors performing an audit at a DC.

Heiko Schöder ◽  
Thomas A. Hope ◽  
Michael Knopp ◽  
William K. Kelly ◽  
Jeff M. Michalski ◽  

PURPOSE As prostate-specific membrane antigen (PSMA) positron emission tomography (PET) becomes increasingly available in the United States, the greater sensitivity of the technology in comparison to conventional imaging poses challenges for clinical trials. The NCI Clinical Imaging Steering Committee (CISC) PSMA PET Working Group was convened to coordinate the identification of these challenges in various clinical scenarios and to develop consensus recommendations on how best to integrate PSMA PET into ongoing and upcoming National Clinical Trials Network (NCTN) trials. METHODS NCI CISC and NCI Genitourinary Steering Committee members and leadership nominated clinicians, biostatisticians, patient advocates, and other imaging experts for inclusion in the PSMA PET Working Group. From April to July 2021, the working group met independently and in conjunction with the CISC to frame challenges, including stage migration, response assessment, trial logistics, and statistical challenges, and to discuss proposed solutions. An anonymous, open-ended survey was distributed to members to collect feedback on challenges faced. Representatives from each NCTN group were invited to present an overview of affected trials. From these discussions, the consensus document was developed and circulated for the inclusion of multiple rounds of feedback from both the Working Group and CISC. RESULTS The current consensus document outlines the key challenges for clinical prostate cancer trials resulting from the increasing availability of PSMA PET. We discuss implications for patient selection and definition of end points and provide guidance and potential solutions for different clinical scenarios, particularly with regard to best practices in defining eligibility criteria and outcome measures. RECOMMENDATIONS This article provides guidance regarding clinical trial design and conduct, and the interpretation of trial results.

2022 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Yeamin Jacky ◽  
Noor Adwa Sulaiman

PurposeThis study examines the perceptions of interested stakeholders on the factors affecting the use of data analytics (DA) in financial statement audits. Response letters submitted by stakeholders of the auditing services to the International Auditing and Assurance Standards Board's (IAASB) Data Analytics Working Group (DAWG) served as sources for analysis.Design/methodology/approachThe modified information technology audit model was used as a framework to perform a direct content analysis of all the 50 response letters submitted to the DAWG.FindingsThe analysis showed that a range of attributes, such as the usefulness of DA in auditing, authoritative guidance (auditing standards), data reliability and quality, auditors' skills, clients' factors and costs, were the factors perceived by stakeholders to be affecting the use of DA in external auditing.Research limitations/implicationsThis study is subjected to the limitations inherent to all content analysis studies. Nonetheless, the findings offer additional insights about potential factors affecting the adoption of DA in audit practices.Originality/valueThe data noted in the published statements highlighted the perceptions of a range of stakeholders with regards to the factors affecting the use of DA in auditing.

2022 ◽  
pp. 105566562110698
Matthew Fell ◽  
Michael Goldwasser ◽  
B.S. Jayanth ◽  
Rui Manuel Rodrigues Pereira ◽  
Christian Tshisuz Nawej ◽  

A consortium of global cleft professionals, predominantly from low- and middle-income countries, identified adaptations to cleft care protocols during and after COVID-19 as a priority learning area of need. A multidisciplinary international working group met on a videoconferencing platform in a multi-staged process to make consensus recommendations for adaptations to cleft protocols within resource-constrained settings. Feedback was sought from a roundtable discussion forum and global organizations involved in comprehensive cleft care. Foundational principles were agreed to enable recommendations to be globally relevant and two areas of focus within the specified topic were identified. First the safety aspects of cleft surgery protocols were scrutinized and COVID-19 adaptations, specifically in the pre- and perioperative periods, were highlighted. Second, surgical procedures and cleft care services were prioritized according to their relationship to functional outcomes and time-sensitivity. The surgical procedures assigned the highest priority were emergent interventions for breathing and nutritional requirements and primary palatoplasty. The cleft care services assigned the highest priority were new-born assessments, pediatric support for children with syndromes, management of acute dental or auditory infections and speech pathology intervention. A collaborative, interdisciplinary and international working group delivered consensus recommendations to assist with the provision of cleft care in low- and middle-income countries. At a time of global cleft care delays due to COVID-19, a united approach amongst global cleft care providers will be advantageous to advocate for children born with cleft lip and palate in resource-constrained settings.

2022 ◽  

This series was launched in 2021 by the Working Group of Economic and Social History of the Pécs Regional Committee of the Hungarian Academy of Sciences to present research conducted within its framework. The foreign language edition is meant to be a contribution to the internationalization of research made in Hungary. The Working Group has made every effort since the publication of the first two volumes to allow its members, and also their Ph.D. students, to publish their findings more easily and in larger volume, providing at the same time an opportunity for other professionals in the region of South Transdanubia to publish their researches. The majority of the studies in this book, similarly to the first volume of the series, are about the history of the region, but some of the papers go beyond this theme. The diversity of the papers created an inspiring environment for the authors, which in turn has greatly stimulated the already existing professional cooperation among them. Both the editors and the authors find it very important to popularise the economic and social history of the region as broadly as possible, in line with the ambitions of the Pécs Regional Committee of the Hungarian Academy of Sciences. In addition, this book also promotes the cooperation among generations of researchers; it is not only the young that enjoy the support of their senior colleagues but the ideas and momentum of the younger generation also keep the activity of the Working Group at a high level. It is due to the well-functioning generational discussions, among other things, that several young researchers earned their Ph.D. degree in 2021. The framework of the studies in the broader sense is the economic and social history of Hungary and Europe in the 18th – 20th centuries. The papers in this volume also provide information about the development and current phases of the different pieces of research. Several papers are sequels to publications released in 2021 from a chronological or thematic aspect, however the book contains brand new topics as well. Great significance is attributed to the fact that several renowned international members of the research network of the Working Group were also persuaded to publish. The results of some ongoing Ph.D. research are also presented. The high number of young authors is a proof that the professional interest in economic and social history is not decreasing at all. We do hope that this book will contribute to the maintenance of this trend.

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