Animal-free safety assessment of chemicals: an innovation system perspective.

This perspective paper, which is the result of a collaborative effort between toxicologists and scholars in innovation and transition studies, presents a heuristic framework based on innovation system literature for understanding and appraising mission achievement to animal-free chemical safety assessment using New Approach Methodologies (NAMs). While scientific and technical challenges in this area are relatively well known, the recent establishment of missions and roadmaps to accelerate the acceptance and effective use of NAMs for chemical safety assessment raises new questions about how we can grasp the systemic nature of all changes needed in this transition. This includes recognising broader societal, institutional, and regulatory shifts necessary for NAM acceptance and uptake.

Making Co-Design More Responsible: Case Study on the Development of an AI-Based Decision Support System in Dementia Care.

Background: Emerging technologies such as artificial intelligence (AI) require an early-stage assessment of potential societal and ethical implications to increase their acceptability, desirability, and sustainability. This paper explores and compares 2 of these assessment approaches: the responsible innovation (RI) framework originating from technology studies and the co-design approach originating from design studies. While the RI framework has been introduced to guide early-stage technology assessment through anticipation, inclusion, reflexivity, and responsiveness, co-design is a commonly accepted approach in the development of technologies to support the care for older adults with frailty.

AI-Assisted Decision-Making in Long-Term Care: Qualitative Study on Prerequisites for Responsible Innovation.

Background: Although the use of artificial intelligence (AI)-based technologies, such as AI-based decision support systems (AI-DSSs), can help sustain and improve the quality and efficiency of care, their deployment creates ethical and social challenges. In recent years, a growing prevalence of high-level guidelines and frameworks for responsible AI innovation has been observed. However, few studies have specified the responsible embedding of AI-based technologies, such as AI-DSSs, in specific contexts, such as the nursing process in long-term care (LTC) for older adults.

Exploring the feasibility of introducing triple artemisinin-based combination therapy in the malaria treatment policy in Vietnam.

Background: This study investigates the processes regarding changing malaria treatment policies in Vietnam. Moreover, it explores the feasibility of introducing triple artemisinin-based combination therapy (TACT) in Vietnam to support the national malaria control and elimination plan.

Methods: Data were collected via 12 in-depth interviews with key stakeholders, combined with a review of policy documents.

The impact of anti-malarial markets on artemisinin resistance: perspectives from Burkina Faso.

Background: Widespread artemisinin resistance in Africa could be catastrophic when drawing parallels with the failure of chloroquine in the 1970s and 1980s. This article explores the role of anti-malarial market characteristics in the emergence and spread of arteminisin resistance in African countries, drawing on perspectives from Burkina Faso.

Methods: Data were collected through in-depth interviews and focus group discussions.

Strategies for deploying triple artemisinin-based combination therapy in the Greater Mekong Subregion.

Background: This is a qualitative study to identify implementation challenges for deploying triple artemisinin-based combination therapy (TACT) in the Greater Mekong Subregion (GMS) of Southeast Asia and to explore strategies to overcome these challenges.

Methods: In-depth interviews were conducted in three countries that have repeatedly been confronted with ACT failures: Cambodia, Vietnam, and Lao PDR. Thirty-nine key stakeholders in the healthcare systems in these countries were interviewed.

Mental models of the protein shift: Exploring consumers' perceptions of the transition.

The protein transition is one of today's major societal challenges to mitigate climate change. To support lasting consumer engagement, it has been suggested to look into consumers' understanding of the protein transition to identify barriers that go beyond the practical issues of changing one's diet. The current study explored consumers' mental models of how the transition unfolds to examine which factors consumers perceive as important drivers of the transition.

Translatability of preclinical to early clinical tolerable and pharmacologically active dose ranges for central nervous system active drugs.

The primary purpose of this study was to assess the translatability of preclinical to early clinical tolerable and pharmacologically active dose ranges for central nervous system (CNS) active drugs. As a part of this, IBs were reviewed on reporting quality. Investigator's Brochures (IBs) of studies performed at the Centre for Human Drug Research (CHDR) reporting statistically significant results of CNS activity related to the drug's mechanism of action were included.

How do people understand the spread of COVID-19 infections? Mapping mental models of factors contributing to the pandemic.

Objective: To describe the mental models people hold about the COVID-19 pandemic, with a focus on how they understand the factors that drive the spread of COVID-19 and what kind of beliefs are associated with these models.

Design: In a series of three studies (total N = 461), we asked participants to identify factors that are relevant for COVID-19 proliferation (Study 1a), rate the importance of factors (Study 1 b), and create a mental model of how these factors relate to virus spread by employing a validated tool for mental model elicitation (Study 2). Main outcome measures: inclusion and centrality of factors in mental models of COVID-19 infection spread.

Social pharmaceutical innovation and alternative forms of research, development and deployment for drugs for rare diseases.

Rare diseases are associated with difficulties in addressing unmet medical needs, lack of access to treatment, high prices, evidentiary mismatch, equity, etc. While challenges facing the development of drugs for rare diseases are experienced differently globally (i.e.

Implementation of Magnetic Resonance Imaging-Guided Radiation Therapy in Routine Care: Opportunities and Challenges in the United States.

Purpose: Magnetic resonance image (MRI)-guided radiation therapy with the 1.5 Tesla magnetic resonance linear accelerator (MR-Linac) is a rapidly evolving and emerging treatment. The MR-Linac literature mainly focused on clinical and technological factors in technology implementation, but it is relatively silent on health care system-related factors.

Market Formation in a Global Health Transition.

Transition studies have started to focus on market formation in innovation systems. This article investigates market formation in a global health transition that was instigated by drug-resistant malaria. We explore how markets for Artemisinin-based Combination Therapies (ACT) in the Greater Mekong Subregion (GMS) were formed at multiple geographical scales and locations.

Toward Responsible Artificial Intelligence in Long-Term Care: A Scoping Review on Practical Approaches.

Background And Objectives: Artificial intelligence (AI) is widely positioned to become a key element of intelligent technologies used in the long-term care (LTC) for older adults. The increasing relevance and adoption of AI has encouraged debate over the societal and ethical implications of introducing and scaling AI. This scoping review investigates how the design and implementation of AI technologies in LTC is addressed responsibly: so-called responsible innovation (RI).

To what extent are the antimalarial markets in African countries ready for a transition to triple artemisinin-based combination therapies?

Introduction: Triple artemisinin-based combination therapies (TACTs) are being developed as a response to artemisinin and partner drug resistance in the treatment of falciparum malaria in Southeast Asia. In African countries, where current artemisinin-based combination therapies (ACTs) are still effective, TACTs have the potential to benefit the larger community and future patients by mitigating the risk of drug resistance. This study explores the extent to which the antimalarial drug markets in African countries are ready for a transition to TACTs.

Ethical, Regulatory and Market related aspects of Deploying Triple Artemisinin-Based Combination Therapies for Malaria treatment in Africa: A study protocol.

According to the World Malaria Report 2019, Africa accounts for 94% of the global malaria deaths. While malaria prevalence and mortality have declined over the years, recent reports suggest that these gains may stand the risk of being reversed if resistance to Artemisinin Combination Therapies (ACTs) spreads from Southeast Asia to Africa. Efforts are being made to develop new treatments that will address the looming threat of ACT resistance, including the development of triple artemisinin combination therapies (TACTs).

From Mattering to Mattering More: 'Goods' and 'Bads' in Ageing and Innovation Policy Discourses.

This paper provides an empirical ethics analysis of the goods and bads enacted in EU ageing and innovation policy discourses. It revolves around a case study of the persona Maria, developed as part of the EU's Active and Healthy Ageing Policies. Drawing on Pols' empirical ethics as a theoretical and methodological approach, we describe the variety of goods (practices/situations to be strived for) and bads (practices/situations to be avoided) that are articulated in Maria's persona.

Problems and Promises of Introducing the Magnetic Resonance Imaging Linear Accelerator Into Routine Care: The Case of Prostate Cancer.

The new radiotherapy high field, 1.5 Tesla MRI-guided linear accelerator (MR-Linac) is being clinically introduced. Sensing and evaluating opportunities and barriers at an early stage will facilitate its eventual scale-up.

Levelling the Translational Gap for Animal to Human Efficacy Data.

Reports of a reproducibility crisis combined with a high attrition rate in the pharmaceutical industry have put animal research increasingly under scrutiny in the past decade. Many researchers and the general public now question whether there is still a justification for conducting animal studies. While criticism of the current modus operandi in preclinical research is certainly warranted, the data on which these discussions are based are often unreliable.

Tradition, not science, is the basis of animal model selection in translational and applied research.

National and international laws and regulations exist to protect animals used for scientific purposes in translational and applied research, which includes drug development. However, multiple animal models are available for each disease. We evaluated the argumentation behind the selection of a specific animal model using thematic content analysis in project applications issued in 2017-2019 in the Netherlands.

Implementation of artificial intelligence (AI) applications in radiology: hindering and facilitating factors.

Objective: The objective was to identify barriers and facilitators to the implementation of artificial intelligence (AI) applications in clinical radiology in The Netherlands.

Materials And Methods: Using an embedded multiple case study, an exploratory, qualitative research design was followed. Data collection consisted of 24 semi-structured interviews from seven Dutch hospitals.

Comparison of drug efficacy in two animal models of type 2 diabetes: A systematic review and meta-analysis.

Previous qualitative research has suggested there are only minor differences between the db/db mouse and the Zucker Diabetic Fatty (ZDF) rat, both animal models of type 2 diabetes. However, it is not known whether these models are also comparable regarding drug response in quantitative terms (effect size). To investigate the extent of these differences, we conducted a systematic review and meta-analysis of approved drugs in these models.

In-Hospital Production of Medicines: Preparing for Disruption.

In-hospital production of affordable medicines holds potential to address problems of drug accessibility. However, expanding the scope of magistral preparation to include high-cost drugs and complex biologicals gives rise to new challenges. We discuss ethical and regulatory complexities faced by Dutch initiatives defying the current pharmaceutical system through magistral preparation.

Correction: A standardised framework to identify optimal animal models for efficacy assessment in drug development.

[This corrects the article DOI: 10.1371/journal.pone.