Opportunities and challenges for decentralized clinical trials: European regulators' perspective

AJ de Jong, TI van Rijssel… - Clinical …, 2022 - Wiley Online Library
Decentralized clinical trials (DCTs) have the potential to improve accessibility, diversity, and
retention in clinical trials by moving trial activities to participants' homes and local …

Decentralized clinical trials (DCTs): A few ethical considerations

C Petrini, C Mannelli, L Riva, S Gainotti… - Frontiers in public …, 2022 - frontiersin.org
Decentralized clinical trials (DCTs) are studies in which the need for patients to physically
access hospital-based trial sites is reduced or eliminated. The CoViD-19 pandemic has …

Weaponising microbes for peace

S Anand, JE Hallsworth, J Timmis… - Microbial …, 2023 - Wiley Online Library
There is much human disadvantage and unmet need in the world, including deficits in basic
resources and services considered to be human rights, such as drinking water, sanitation …

[HTML][HTML] Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus

Y Santa-Ana-Tellez, B Lagerwaard, AJ de Jong… - Drug Discovery …, 2023 - Elsevier
There is increasing interest in clinical trials that use technologies and other innovative
operational approaches to organise trial activities around trial participants instead of …

Recommendations to promote equity, diversity and inclusion in decentralized clinical trials

OL Aiyegbusi, S Cruz Rivera, P Kamudoni… - Nature Medicine, 2024 - nature.com
Decentralized clinical trials involving the use of digital tools to facilitate remote research are
gaining momentum. Rapid advancements in digital technologies have supported the …

[HTML][HTML] The audiogram: Detection of pure-tone stimuli in ototoxicity monitoring and assessments of investigational medicines for the inner ear

CG Le Prell, CC Brewer, K Campbell - The Journal of the Acoustical …, 2022 - pubs.aip.org
Pure-tone thresholds have long served as a gold standard for evaluating hearing sensitivity
and documenting hearing changes related to medical treatments, toxic or otherwise …

Sponsor perspectives on the impact of the COVID-19 pandemic on interventional cancer clinical trial protocols and data quality

JM Unger, H Stires, LA Levit, M Stewart… - JCO Oncology …, 2023 - ascopubs.org
PURPOSE The onset of the COVID-19 pandemic created major disruptions in the conduct of
cancer clinical trials. In response, regulators and sponsors allowed modifications to …

[HTML][HTML] Regulatory readiness to facilitate the appropriate use of innovation in clinical trials: The case of decentralized clinical trial approaches

AJ de Jong, MGP Zuidgeest, Y Santa-Ana-Tellez… - Drug Discovery …, 2024 - Elsevier
Methodological and operational clinical trial innovation is needed to address key challenges
associated with clinical trials, including limited generalizability and (s) low recruitment rates …

Structural analysis and intelligent classification of clinical trial eligibility criteria based on deep learning and medical text mining

Y Han, Q Su, L Liu, Y Li, J Huang - Journal of Biomedical Informatics, 2024 - Elsevier
Objective: To enhance the efficiency, quality, and innovation capability of clinical trials, this
paper introduces a novel model called CTEC-AC (Clinical Trial Eligibility Criteria Automatic …

A/B design testing of a clinical trial recruitment website: A pilot study to enhance the enrollment of older adults

HN Miller, TB Plante, KT Gleason, J Charleston… - Contemporary clinical …, 2021 - Elsevier
Introduction Online tools are increasingly utilized in clinical trial recruitment. A/B testing is an
effective technology used in political campaigns and commercial marketing to improve …