Decentralized clinical trials are better for the participants and for the planet: the case study of a double-blind randomized controlled trial in Singapore (PROMOTE study)

Frontiers in Public Health, Год журнала: 2025, Номер 12

Опубликована: Янв. 13, 2025

Introduction Novel technologies have enabled the decentralization of many aspects clinical trials, but little research has been done on impact these changes participant experience, trial operations, or environment. Methods A fully decentralized conducted in Singapore is used as a case study to evaluate operational outcomes, environmental (via life cycle assessment), and participants experience (qualitative interviews) model compared traditional with in-person visits. Results The achieved high retention rates (97%) completion for data, even biological samples. Participants found be convenient safe, especially during pandemic. Moreover, was more environmentally friendly less detrimental human health face-to-face primarily by reducing participants’ use cars site Discussion While this focused impact, it important consider other factors such safety, convenience, data quality when evaluating suitability approach. Careful planning flow, database structure, protection measures essential. This contributes improving footprint trials. Environmental sustainability should among that are evaluated selecting models. Decentralized hybrid trials offer efficiency, effectiveness, benefits. Further adoption approaches encouraged.

Язык: Английский

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Patient-centric clinical trials: collaboration and innovation in bioanalytical and clinical operations

Bioanalysis, Год журнала: 2025, Номер unknown, С. 1 - 4

Опубликована: Янв. 30, 2025

KEYWORDS: Decentralized clinical trialspatient-centric trialsbioanalytical methodsclinical operationsinnovationtechnologypatient engagementcollaboration

Язык: Английский

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Global Patterns of Hemophilia Drug Trials, Hemophilia Care, and Healthcare Measures

Research and Practice in Thrombosis and Haemostasis, Год журнала: 2025, Номер 9(2), С. 102714 - 102714

Опубликована: Фев. 1, 2025

Язык: Английский

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Brain Network Alterations in Fragile X Syndrome

Neuroscience & Biobehavioral Reviews, Год журнала: 2025, Номер unknown, С. 106101 - 106101

Опубликована: Март 1, 2025

Язык: Английский

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Digital Sexual Health Education for Young Adults (18–35 Years): A Scoping Review Protocol

Health Science Reports, Год журнала: 2025, Номер 8(5)

Опубликована: Апрель 28, 2025

ABSTRACT Background and Aims Young adults is a key stage for sexual development. Digital interventions provide innovative ways to deliver health education young adults. This scoping review protocol outlines plan map the existing literature on digital (DSHE) adults, focusing dimensions characteristics of these interventions. Methods will adhere comprehensive 14‐step methodological framework, integrating established Arksey O'Malley methodology with enhancements by Tricco Peters. follow PRISMA‐ScR guidelines. The study selection process adhered PICOS framework. A combination thesauri free‐text methods be employed. Keywords within each concept were connected using Boolean operator “OR,” whereas different concepts linked “AND.” Databases such as Web Science (ISI), PubMed, Scopus, EMBASE, Cochrane Library (CDSR, Central) search engines Google Scholar Elmnet utilized. extracted data synthesized presented diagrams tables accompanied narrative summary. Discussion valuable synthesis current state DSHE findings are intended inform development implementation effective programs researchers, educators, policymakers, healthcare providers. Ultimately, this contributes broader effort improve Ethical Code IR.SHMU.REC.1403.085.

Язык: Английский

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Preventing suicide with Safe Alternatives for Teens and Youths (SAFETY): a randomised feasibility trial

BMJ Mental Health, Год журнала: 2025, Номер 28(1), С. e301575 - e301575

Опубликована: Апрель 1, 2025

Suicide attempts are common in youth and have potentially lethal outcomes. Effective treatments targeting suicide scarce. To assess the feasibility preliminary efficacy of a family-based cognitive behavioural treatment relative to an active control for with suicidal behaviour. 30 youths (93% female; mean (SD) age=14.6 (1.5) years) residing Sweden recent behaviour (last 3 months) at least one available parent were randomised 12 weeks Safe Alternatives Teens Youths (SAFETY) or supportive therapy, treatment. Primary endpoint was 3-month post-treatment. Feasibility outcomes included assessment compliance, adverse events, credibility satisfaction. Secondary attempt, non-suicidal self-injury, anxiety, depression, quality life emotion dysregulation. Both showed high satisfaction, session completion, few events dropouts as well low attrition (7% primary endpoint). At endpoint, two (14%) participants SAFETY four (27%) therapy had attempted suicide. Non-suicidal self-injury reduced by 95% (incidence rate ratio=0.05 (95% CI 0.01 0.20)) 69% ratio=0.31 (0.11 0.83)) therapy. Participation SAFETY, but not associated moderate-to-large within-group improvements anxiety depression (Cohen's d=0.85 [0.33 1.40]), (d=1.01 [0.48 1.56]) dysregulation (d=1.22 [0.45 2.03]). The results suggest that is feasible promising A large controlled trial warranted further examine SAFETY. NCT05537623.

Язык: Английский

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Benefits that Offset Research Risks and Burdens are Qualitatively Different

The American Journal of Bioethics, Год журнала: 2025, Номер 25(5), С. 78 - 80

Опубликована: Май 4, 2025

Язык: Английский

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Exploring Barriers to Inclusivity: Systematic Analysis of Exclusion Criteria and Potential Bias in Clinical Cancer Trials for Psychiatric and Neurological Conditions in European Protocols

Psycho-Oncology, Год журнала: 2025, Номер 34(5)

Опубликована: Май 1, 2025

ABSTRACT Background Cancer clinical trials often employ exclusion criteria that can impact vulnerable populations, particularly individuals with psychological, psychiatric, or neurological conditions. Aims This study aimed to analyze the prevalence and nature of in for prostate, breast, lung cancers. Methods The EU Clinical Trials Register identified 51 protocols uploaded between 2022 2024. Thematic content analysis categorized criteria, justifications provided, while frequency quantified their prevalence. Results After excluding five (two non‐English three inaccessible), final dataset comprised 46 protocols: 13 prostate cancer (22.8%), 24 breast (42.1%), 9 (15.8%). Exclusion targeting populations were present 78.3% protocols, into themes: psychiatric conditions (24.6%), other psychological legal/guardianship status (5.3%), unspecified (24.6%). Compliance concerns (39.1%) most common justification, followed by informed consent challenges (32.6%), safety risks (13%), drug interference (10.9%), not best interest (4.3%). Notably, 29.1% lacked justification exclusions, raising ethical transparency concerns. Conclusions may limit inclusivity generalizability research. Heuristic biases systemic practices potentially influence this. Exploring role these factors considering adaptive trial designs, along providing detailed could support more equitable representative

Язык: Английский

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Scientific consideration of sex and gender is the responsibility of the many, not the few

The Lancet, Год журнала: 2024, Номер 404(10468), С. 2140 - 2142

Опубликована: Ноя. 1, 2024

Язык: Английский

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