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.
View Article and Find Full Text PDFBackground: 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.
View Article and Find Full Text PDFIslet delivery devices (IDDs) offer potential benefits for islet transplantation and stem cell-based replacement in type 1 diabetes. Little is known about patient preferences regarding islet delivery device characteristics and implantation strategies. Patient preferences for IDDs and implantation strategies remain understudied.
View Article and Find Full Text PDFBackground: 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.
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.
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.
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.
View Article and Find Full Text PDFObjectives: The In Vitro Diagnostics Regulation 2017/746 (IVDR) coming into force from May 2022, creates the first European regulatory recognition for biomarker tests linked to medicinal products, so-called companion diagnostics (CDx). Since the introduction of the IVDR is associated with uncertainties about its impact on hospital practice, it is urgent and valuable to investigate how and why CDx are currently used in hospital practice, which factors influence the choice for applying in-house or commercial CDx, and what the expectations are about how the IVDR may affect current practice.
Methods: We investigated these questions using an interview-based approach and focused on 15 hospital laboratories in the Netherlands, including 7 academic and 8 general hospitals.
Background: Triple Artemisinin-based Combination Therapies (TACTs) are being developed as a response to artemisinin and partner drug resistance in Southeast Asia. However, the desirability, timing and practical feasibility of introducing TACTs in Southeast Asia is subject to debate. This study systematically assesses perspectives of malaria experts towards the introduction of TACTs as first-line treatment for uncomplicated falciparum malaria in Southeast Asia.
View Article and Find Full Text PDFTransition 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.
View Article and Find Full Text PDFBackground 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).
View Article and Find Full Text PDFIntroduction: 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.
View Article and Find Full Text PDFWellcome Open Res
April 2021
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).
View Article and Find Full Text PDFReports 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.
View Article and Find Full Text PDFNational 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.
View Article and Find Full Text PDFObjective: 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.
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.
View Article and Find Full Text PDFClinical trial failures (>99%) in Alzheimer's disease are in stark contrast to positive efficacy data in animals. We evaluated the correlation between animal and clinical efficacy outcomes (cognition) in Alzheimer's disease using data from registered drugs as well as interventions tested in phase II or III clinical trials for Alzheimer's disease. We identified 20 interventions, which were tested in 208 animal studies in 63 different animal models.
View Article and Find Full Text PDFIntroduction: Poor translation of efficacy data derived from animal models can lead to clinical trials unlikely to benefit patients-or even put them at risk-and is a potential contributor to costly and unnecessary attrition in drug development.
Objectives: To develop a tool to assess, validate and compare the clinical translatability of animal models used for the preliminary assessment of efficacy.
Design And Results: We performed a scoping review to identify the key aspects used to validate animal models.
Background: A rapid diagnostic tool is being developed to discern severely ill children with severe malaria from children who are ill with alternative febrile diseases but have coincidental peripheral blood parasitaemia. The device semi-quantitatively measures plasma pfHRP2 and has the potential to reduce mortality in children with severe febrile illnesses by improving diagnosis. The aim of this study is to identify contributing and inhibiting factors that affect healthcare practitioners' acceptability of this prospective diagnostic device in a high malaria transmission setting in the Democratic Republic of Congo.
View Article and Find Full Text PDFPurpose: The aim of this study is to provide a comprehensive overview of the outcomes of marketing authorisation applications via the mutual recognition and decentralised procedures (MRP/DCP) and assess determinants of licensing failure during CMDh referral procedures.
Methods: All MRP/DCP procedures to the Co-ordination group for Mutual recognition and Decentralised procedures-human (CMDh) during the period from January 2006 to December 2013 were analysed. Reasons for starting referral procedures were scored.
Sociol Health Illn
January 2011
Current research into patient advocacy focuses on attempts of patient groups to mobilise resources and to influence researchers, pharmaceutical companies and policy-makers. This paper adopts a 'framing political opportunities' approach to draw attention to other kinds of advocacy strategies. In a case study of breast cancer patient advocacy of Herceptin reimbursement, it is shown how patient groups tried to gain access to policy-making by means of three different opportunity-framing strategies.
View Article and Find Full Text PDFTraditionally, innovation in the pharmaceutical industry is organised according to the linear model. Over the past two decades this model lost its meaning as a result of rising costs, increased competition, new scientific developments and better-informed, more demanding users. The linear model is not well equipped to involve these new actors and to include their feedback.
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