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Artificial intelligence in clinical trials: A comprehensive review of opportunities, challenges, and future directions
No full textBackground
Clinical trials face unprecedented challenges including recruitment delays affecting 80% of studies, escalating costs exceeding $200 billion annually in pharmaceutical R&D, success rates below 12%, and data quality issues affecting 50% of datasets. Artificial intelligence (AI) offers transformative solutions to address these systemic inefficiencies across the clinical trial lifecycle.
Objective
To evaluate the current state, future potential, and implementation challenges of AI technologies in clinical trials, providing evidence-based guidance for responsible AI integration while maintaining patient safety and scientific integrity.
Method
Comprehensive narrative review following established guidelines for literature synthesis. Systematic search of PubMed, Embase, IEEE Xplore, and Google Scholar databases from January 2015 to December 2024. Data extraction and narrative synthesis organized thematically according to clinical trial lifecycle stages.
Results
Analysis of relevant studies demonstrated substantial AI benefits: patient recruitment tools improved enrollment rates by 65%, predictive analytics models achieved 85% accuracy in forecasting trial outcomes, and AI integration accelerated trial timelines by 30–50% while reducing costs by up to 40%. Digital biomarkers enabled continuous monitoring with 90% sensitivity for adverse event detection. However, significant implementation barriers emerged, including data interoperability challenges, regulatory uncertainty, algorithmic bias concerns, and limited stakeholder trust.
Conclusion
AI represents a transformative force in clinical research with proven capabilities to enhance efficiency, reduce costs, and improve patient outcomes. Realizing this potential requires addressing technical infrastructure limitations, developing explainable AI systems, establishing comprehensive regulatory frameworks, and fostering collaborative efforts between technology developers, clinical researchers, and regulatory agencies to ensure responsible implementation
Enhancing Digital Heritage Experiences: Evaluating Fine-Tuned LLM Integration within a Cyber-Physical-Social Virtual Museum System
No full textThe Metaverse is rapidly advancing, creating new ways to connect real and digital spaces. In Digital Cultural Heritage, technologies such as Artificial Intelligence, eXtended Reality, and Digital Twins are transforming how cultural knowledge is preserved and experienced. Cyber-Physical-Social Systems (CPSS) provide a foundation for such applications, yet the role of Large Language Models (LLMs) in these systems remains underexplored. This paper presents the architecture and development of a CPSS-based virtual museum prototype and reports on a comparative evaluation of LLM integration for contextual information delivery. We fine-tuned Mistral 7B with LoRA on domain-specific data and compared it against the baseline model through expert human evaluation on factual accuracy, relevance, safety, alignment, and formatting. Results show the fine-tuned model outperformed the baseline by ≈+5.5%, particularly in accuracy, contextual relevance, and response formatting. These findings demonstrate the value of tailored LLMs as a core component of CPSS for enhancing digital heritage experiences and create new ways for future exploration of additional models and approaches
Audio Criminology: Broadening the criminological imagination through the use of audio methods
No full textCriminology has traditionally drawn upon a narrow range of research methods, with more varied methods employed at the margins of the discipline. Thus, the potential for criminological discovery has been bound by a limited array of research tools and diversifying the criminological toolkit could unearth new revelations or breakthroughs in the discipline. This chapter advocates for criminologists to expand their criminological imagination and consider the benefits that audio research methods can provide to the discipline. An examination of the range of audio methods such as sound walks, audio-computer assisted interviews, audio diaries, and soundscapes is provided, before considering the utility of audio vignettes in research on attitudes towards sex work
British Society of Gastroenterology guidelines on colorectal surveillance in inflammatory bowel disease
Get PDFPatients with inflammatory bowel disease (IBD) remain at increased risk for colorectal cancer and death from colorectal cancer compared with the general population despite improvements in inflammation control with advanced therapies, colonoscopic surveillance and reductions in environmental risk factors. This guideline update from 2010 for colorectal surveillance of patients over 16 years with colonic inflammatory bowel disease was developed by stakeholders representing UK physicians, endoscopists, surgeons, specialist nurses and patients with GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodological support.
An a priori protocol was published describing the approach to three levels of statement: GRADE recommendations, good practice statements or expert opinion statements. A systematic review of 7599 publications, with appraisal and GRADE analysis of trials and network meta-analysis, where appropriate, was performed. Risk thresholding guided GRADE judgements.
We made 73 statements for the delivery of an IBD colorectal surveillance service, including outcome standards for service and endoscopist audit, and the importance of shared decision-making with patients.
Core areas include: risk of colorectal cancer, IBD-related post-colonoscopy colorectal cancer; service organisation and supporting patient concordance; starting and stopping surveillance, who should or should not receive surveillance; risk stratification, including web-based multivariate risk calculation of surveillance intervals; colonoscopic modalities, bowel preparation, biomarkers and artificial intelligence aided detection; chemoprevention; the role of non-conventional dysplasia, serrated lesions and non-targeted biopsies; management of dysplasia, both endoscopic and surgical, and the structure and role of the multidisciplinary team in IBD dysplasia management; training in IBD colonoscopic surveillance, sustainability (green endoscopy), cost-effectiveness and patient experience. Sixteen research priorities are suggested
Dark events and remaking our lifeworld
No full textDeath is universal, yet dying is not. Death is the culmination of life and living, and as finite biological beings – as we shall live, we shall die. Indeed, our ‘lifeworld’ encompasses our sense of mortality as a part of the pre-reflective, taken-for-granted realm where we interact. In our lifeworld, a dynamic and constantly evolving backdrop exists that offers us context for understanding social interactions, communication, and the reproduction of social structures. Some of this lifeworld involves facing the inescapable notion of death. Yet while death will come to all of us, the societal process of dying – namely the deathbed – is a culturally fluid and dynamic ritual system that transforms between places and through time. This chapter addresses the cross-cultural and globally dynamic case examples in this book, suggesting dark events are formed within diverse ontological contexts and, subsequently, layered with social functions to help form our existential lifeworld. Presenting dark events as a response to shifting landscapes of culture, environments, and emotions, this chapter affirms that in a world that appears to spin ever faster with global anxieties and cultural transformations of the deathbed, dark events allow us to make our own lifeworld – in the face of inevitable mortality
How is a ‘Trauma-Informed’ approach experienced and perceived by staff and survivors in a Domestic Abuse service?
No full textTrauma-informed approaches (TIAs) have evolved from an individualised clinical intervention model to address the symptoms of post-traumatic stress disorder (PTSD) to a psycho-social educational empowerment approach into a new holistic paradigm for service delivery. TIAs are increasingly being adopted by UK domestic violence service provision. Much of the existing literature on the implementation of trauma informed approaches in domestic abuse service provision does not include survivor perspectives, and very few studies include survivor and practitioner perspectives. Consequently, much of the existing research offers little understanding of how practitioners and survivors conceptualise and utilise a trauma-informed approach or provide insight into operational and contextual barriers for the domestic abuse sector in harnessing a trauma-informed approach. This study aims to redress this balance by adopting an ecological case study approach focusing on two domestic abuse service provisions in the Northeast of England.
This study is influenced by elements of feminist theory, ecological and systemic theory as well as neurobiological research on psychological trauma and distress, acknowledging the socially constructed conceptualisation of trauma as well as the physiological and psychological experiences of trauma survivors. Data collection took place in two domestic abuse services in the north of England, each offering a range of service provision including refuge provision, advocacy, and counselling. It involved semi structured interviews with 15 domestic abuse practitioners and six domestic abuse survivors.
Originality resides in the ecological adapted case study approach and the inclusion of UK based domestic abuse survivors as well as practitioners. The domestic abuse survivor's Meso-system includes any interaction between professionals that she is engaged with (interactions not involving the survivor directly), which has previously been overlooked in any other study using the ecological framework to examine domestic abuse in the UK. Recommendations include a revised ecological framework that can be used by other domestic abuse researchers who are focussing on service delivery.
Two distinct trauma-informed service delivery models were being harnessed by domestic abuse practitioners across the two services included within the study.
Trauma-informed practice was cited as instrumental in bolstering the legitimacy and credibility of domestic abuse survivors and domestic abuse services. Practitioners also spoke about psychologically distancing themselves by situating challenging behaviours exhibited by survivors in the context of trauma responses.
While the experience level of the practitioner seems to correspond with more nuanced and reflective approach to trauma-informed practice, all practitioners said that a trauma-informed approach helps them to better understand domestic abuse survivors. Practitioners also offer caution about some of the potential barriers to harnessing trauma informed practice in the context of the domestic abuse service provision.
Survivors in this study highlighted the re-traumatising effects of being stigmatised or disbelieved by statutory services and the transformational impact of trauma. While survivors' views on best practice align with some of the principles of trauma-informed practice, they placed the greatest emphasis on being believed and cared for by professionals they work with emphasising the value of the relational component of domestic abuse interventions
Care coordinator delivered method of levels therapy to improve engagement and other outcomes in early psychosis (CAMEO): A feasibility cluster-randomised controlled trial.
No full textThe Method of Levels (MOL) is a theoretically-informed, transdiagnostic cognitive therapy that could improve service user engagement and recovery for individuals with early psychosis. We aimed to assess the feasibility and acceptability of training care coordinators in early intervention in psychosis teams to deliver MOL, and to assess the feasibility of conducting a two-arm parallel-group cluster-randomised controlled trial (C-RCT) with randomisation at the level of teams. Randomisation was in a ratio of 1:2 to either (1: control) treatment as usual (TAU); or (2: intervention) TAU plus support from a care coordinator who has received training in MOL. Clinical and health economic outcomes were collected at baseline, three, and six months. Fourteen early intervention in psychosis teams (117% of target), 31 care coordinators (129% of target), and 49 service users (51% of target) were recruited. Results suggest that some aspects of this study are feasible in their current form (e.g., care coordinator recruitment), other aspects are likely to be feasible with relatively minor adjustments (e.g., service user retention), and some aspects would need substantial changes to make the delivery of an evaluation C-RCT feasible (e.g., service user recruitment; MOL supervision for care coordinators). Progression to an evaluation trial would be justified if plausible solutions can be found to address the feasibility issues identified in this study. [Abstract copyright: Copyright © 2026. Published by Elsevier Inc.
A protocol for a realist review of the acceptability and implementation of health checks for people with an intellectual disability and for autistic people
No full textBackground Autistic people and/or people with an intellectual disability are more likely to experience health conditions and premature mortality. Regular health checks and assessments are known to be useful for some people with an intellectual disability, but provision is not universal, uptake is lower than expected in some areas, with variable outcomes. Evidence for the effectiveness of health checks for autistic people has been gathered. It is important to understand how the NHS can increase health check provision, uptake, quality, and consistency, and how they should be implemented. Further evidence about how and in what ways health checks work for autistic people and people with an intellectual disability is needed. Health professionals and other stakeholders need to understand how to improve health check provision, uptake, and receipt by making them more accessible. This paper outlines a realist review protocol to explore the variable impacts and implementation challenges of health checks for autistic people and people with an intellectual disability. Methods This six-staged realist review will include health checks and assessments for people with an intellectual disability and/or autistic people. The review will address what works, how, why, for whom and under what circumstances. The objective is to identify context-sensitive barriers, solutions and their associated outcomes. This will inform the development of an initial programme theory explaining how and why health checks are effective for people with an intellectual disability and autistic people. Discussion The programme theories refined and developed through the review will inform subsequent stages of a broader study. A realist evaluation will follow to further develop and test these theories with stakeholder collaboration. The resulting programme theory will then be used to develop practical guidance for policymakers and healthcare staff on how to deliver more impactful health checks across diverse contexts. PROSPERO registration CRD42025104119
Trunk and Lower Limb Mechanics during Multi-Directional Cutting in Dominant and Non-dominant Limbs of Athletes: Implications for Anterior Cruciate Ligament Injury Risk
No full textBackground: Understanding the influence of limb dominance and cutting angles on trunk and lower limb biomechanics and trunk muscle activation during multidirectional change of direction (COD) may provide insights into anterior cruciate ligament (ACL) injury risk and preventive management.
Hypothesis/Purpose: This study aimed to investigate the influence of limb dominance and cutting angles on trunk and lower limb biomechanics and trunk muscle activation during multidirectional COD tasks in male athletes. We hypothesized that the dominant limb (DL) and non-dominant limb (NDL) would exhibit notable variations in muscle activation and biomechanics across cutting angles, which could have beneficial implications for training and injury prevention.
Study design: Observational study.
Methods: Twenty male collegiate athletes performed side-step cutting tasks at 30°, 60°, and 90° angles using their DL and NDL limbs. Three-dimensional motion capture, ground reaction force (GRF) data, and surface electromyography (EMG) of trunk and lower limb muscles were collected.
Results: Cutting angles significantly influenced trunk and lower limb biomechanics. Sharper cuts angles (especially 90°) showed significantly diminished trunk and lower limb sagittal-plane motion (p < 0.05) and significantly greater frontal and transverse plane demands (p < 0.05), including increased trunk lean, hip abduction, and internal rotation moments. Limb dominance also demonstrated specific effect; DL showed a significant effect on trunk flexion, trunk rotation, whereas the NDL showed significantly greater ankle external rotation at peak vertical GRF. Muscle activation patterns varied by limb and direction; the NDL exhibited higher gluteus medius and left external oblique activation than the DL. However, joint moments were largely symmetrical across limbs.
Conclusion: Although cutting angle had the most profound impact on biomechanics, limb dominance introduced meaningful differences in trunk control and muscle activation strategies. These asymmetries may influence ACL injury risk profiles and should be considered in sport-specific training and rehabilitation programs
Doing it Ourselves: Crafting a Mad Zine Methodology
No full textThis article describes the approach we developed in our research project about radical mental health zines, or mad zines. Rather than importing a set of accepted methods from elsewhere, we drew on insights from the emerging fields of Zine Studies and Mad Studies and crafted our own DIY approach. As we wanted to develop a methodology that was congruent with the politics, cultures and ethics of both the zine community and mad movements, we attempted to cultivate what we refer to as a Madzine sensibility. We detail that here, alongside the ideas that informed it. We describe how we used this approach to develop the specific methods we used in our research. We are not claiming to have fully resolved any of the ethical-political challenges involved in researching zines in general, or Madzines in particular. Rather, we share here our process, in the hope that it will be useful to the growing numbers of scholars who are researching zines and/or using zines in their research