The Library
1530 papers on microsampling and monitoring, each with a finding paraphrased to our standard and labelled in one vocabulary. Every entry links to a legitimate copy; nothing is copied from an abstract.
Papers 1–100 of 183 labelled “dct”, newest first.
2026
In four crew members, capillary volumetric absorptive microsampling caught altered acetaminophen pharmacokinetics in flight: Cmax rose to 43,300 ng/mL from 9,110 before flight and clearance fell to 3,890 mL/h from 16,200, pointing to toxicity risk at standard dosing; four people only, but a case for microsampling where no clinic can reach.
Volumetric Absorptive Microsampling During Spaceflight for Analysis of Acetaminophen Pharmacokinetics in Whole Blood — Mampre et al., Journal of clinical pharmacology
- blood
- capillary
- vams
- tdm
- dct
2026
Ten decentralised cancer trials run across 47 Veterans Affairs medical centres enrolled 134 patients, nearly a third of them rural and a fifth from minority groups, matching the population the VA's tele-oncology service already reaches. The authors' own caveat stands: remote conduct widened access, and not every trial design can be run this way.
Cancer decentralized clinical trials in the Veterans Health Administration — Friedman et al., Journal of the National Cancer Institute (paywalled)
- dct
2026
The study observed favourable trends in the accrual of participants residing far from the site and those from underrepresented groups following the implementation of a decentralised clinical trial program.
A Multiregional Decentralized Clinical Trial Program to Improve Access — Haddad et al., JAMA network open
- dct
2026
The Australian Teletrial Programme improved patient access to trials and workforce capability through harmonised processes and training, but broader implementation is limited by workforce turnover, complex approvals, and variable leadership engagement. This highlights that systemic policy and governance support are critical for the sustainable integration of decentralised trial models.
Whole-of-system approach for program implementation: Lessons from the Australian Teletrial Program — Sabesan et al., Journal of telemedicine and telecare (paywalled)
- dct
2026
This review suggests that decentralised clinical trials in oncology can improve patient participation and equity but face significant regulatory, logistical and digital hurdles. It concludes that these trials offer a flexible model dependent on specific clinical contexts rather than a universal replacement for conventional methods.
From site-centered to patient-centered: Promises and challenges of decentralized clinical trials in oncology — Gentile et al., Critical reviews in oncology/hematology (paywalled)
- oncology
- dct
2026
The study found that although participants preferred patient-centric microsampling devices for home use, the agreement with venous plasma for measuring CRP and cytokines was inconsistent, indicating that further validation is required before these methods replace standard venipuncture.
Limited agreement of cytokines and CRP through patient-centric microsampling compared to venipuncture in healthy adults — Tuttle et al., Bioanalysis (paywalled)
- dct
- venous-agreement
- acceptability
- blood
- dbs
- self-collection
- dried
- biomarkers
2026
The study demonstrated the feasibility of a fully decentralised design by successfully recruiting 37 participants and completing follow-up for self-collected stool samples without requiring on-site visits.
Perioperative Antibiotic Prophylaxis in Cesarean Section and the Maternal Gut Microbiome: Protocol for a Remote Observational Cohort Study — Feles & Mattner, JMIR research protocols
- stool
- self-collection
- dct
- microbiome
2026
This study validated a low-cost 3D-printed smartphone attachment and paper sensor for measuring glucose, uric acid and cholesterol in saliva, demonstrating high correlation with standard ELISA results in a small clinical cohort. The authors suggest this platform offers a scalable solution for decentralised diabetes management by balancing sensitivity with affordability.
Nanostructured zinc-coordination supraparticles on cellulose fibers: A 3D-Printed μ-FAD integrated smartphone platform for multiplexed salivary metabolic monitoring — Yang et al., Biosensors & bioelectronics (paywalled)
- dct
- economics
- metabolome
- self-collection
- liquid
- validation
- saliva
2026
This study used home self-collected saliva samples to successfully monitor cytokines and cortisol in mothers and infants, finding that a community singing intervention significantly reduced salivary interleukin-6 levels in mothers with postnatal depression.
Community singing intervention reduces maternal salivary cytokines and enhances maternal-infant cortisol synchrony in postnatal depression: biological findings from the SHAPER-PND trial — Kirkpatrick et al., Brain, behavior, and immunity (paywalled)
- dct
- cortisol
- self-collection
- pediatric
- hormones
- liquid
- saliva
- biomarkers
2026
The study determined that an at-home saliva collection protocol using the passive drool method was feasible for Black women with histories of abuse, with 84% of participants completing at least one full day of adherent sampling. While the decentralised approach yielded usable cortisol data, women with histories of forced sex exposure showed lower protocol adherence scores.
Repeat At-Home Saliva Collection to Measure Cortisol Awakening Response (CAR): Protocol Feasibility Study Among Black Women With Histories of Abuse — Tsuyuki et al., Interactive journal of medical research (paywalled)
- dct
- acceptability
- cortisol
- self-collection
- liquid
- saliva
2026
A machine learning model called Remote Control was trained on 2685 blood samples to predict change due to instability, enabling accurate calibration of results to approximate the time zero value at collection. With calibration, unprocessed whole blood could be transported for up to 9 days under ambient conditions and temperatures between 3.4 and 47.4 degrees Celsius, achieving agreement with CLIA TEa between 98.1 and 100 per cent and expanding the catalog of tests available for at-home collection.
Prolonging Sample Stability with Machine Learning Expands the Catalog of Tests Available for Mail-In Capillary Blood Collected At-Home — O'Meara et al., Analytical chemistry (paywalled)
- dct
- blood
- self-collection
- capillary
- liquid
- validation
- biomarkers
2026
This study found strong concordance between capillary samples collected via the Tasso device and standard venous draws for VirScan serology, indicating that self-collected samples are a practical alternative for decentralised research. The authors advise against interchanging these collection methods within a single longitudinal study to avoid introducing technical variability.
Assessing VirScan serosurvey epitope profiling variability between in-clinic venous blood draw and capillary blood self-sampling device — Sircy et al., Microbiology spectrum
- dct
- venous-agreement
- blood
- self-collection
- serology
- capillary
- liquid
2026
Frequent dried blood spot sampling detected early changes in beta-cell function more effectively than mixed-meal tolerance tests or urine ratios, supporting its potential as a decentralised monitoring tool for clinical trials.
Serial Dried Blood Spot C-Peptide Sampling, but Not Urine C-Peptide-to-Creatinine Ratio, Detects Early Preservation of β-Cell Function in New-Onset Type 1 Diabetes: Experience From the USTEKID Trial — Dunseath et al., Diabetes care (paywalled)
- dct
- blood
- dbs
- dried
- pediatric
- urine
- biomarkers
2026
In a pilot mixed-methods study of youth with HIV, mailed HemaSpot-HF kits enabled home-based dried blood spot collection that participants found feasible and acceptable, supporting remote viral load monitoring and a self-management model for decentralised care.
An Examination of Perceptions and Usage of Dried Blood Spot Biosampling Technology for HIV Viral Load Collection Among Youth with HIV — Gurung et al., AIDS and behavior (paywalled)
- blood
- dried
- dbs
- self-collection
- acceptability
- dct
- serology
2026
This developer study reports that a self-collection kit interfacing with a BD Microtainer produced RNA of sufficient quality and yield for transcriptomic analysis in a pilot group and a longitudinal rheumatology cohort. Most participants found the device easy to use, supporting its utility for decentralised blood sampling.
To the homeRNAmax: Developing an Improved Blood Self-Collection and Stabilization Platform for Remote Transcriptomic Studies — Eakman et al., Analytical chemistry (paywalled)
- dct
- blood
- self-collection
- bd-microtainer
- liquid
- validation
- biomarkers
2026
In a feasibility randomised controlled trial with 28 adults aged 65 years, 62% successfully self-collected finger-prick capillary blood samples for influenza antibody and vitamin D measurement. While overall study procedures were acceptable, the capillary sampling method requires refinement before wider deployment in decentralised diagnostics for older adults.
PROTECTIVE-D-a feasibility randomised controlled trial examining the effect of a positive mood intervention and vitamin D supplementation on the immunological responses to influenza vaccination in older adults — Royal et al., Pilot and feasibility studies (paywalled)
- blood
- capillary
- self-collection
- acceptability
- dct
2026
The EpiCom study was co-created with patients, caregivers and healthcare professionals to optimise a decentralised clinical trial framework that reduces participant burden through remote assessments and broader eligibility criteria, highlighting the value of stakeholder collaboration in trial design.
Co-Creation of the EpiCom Clinical Trial: Bringing the Tuberous Sclerosis Complex Patient Community, Healthcare Professionals, and the Pharmaceutical Industry Together — Moore-Ramdin et al., The patient (paywalled)
- dct
2026
A fully remote decentralised clinical trial in Danish adults with type 2 diabetes demonstrated operational feasibility with rapid recruitment, high retention (87 percent), and excellent adherence to continuous glucose monitoring (95 percent achieving ≥70 percent data coverage) and telemedicine visits (97 percent). Activity tracker adherence was poor (12 percent) due to technical issues, but remote safety monitoring was effective with no unexpected adverse events, supporting the viability of remote diabetes management.
Operational and Clinical Insights from a Fully Decentralized Clinical Study Evaluating Protocol Adherence, Participant Satisfaction, and Connected Device Data in Individuals with Type 2 Diabetes on Different Treatment Regimens — Nørgaard et al., Diabetes technology & therapeutics (paywalled)
- dct
- wearable
- rpm
- cgm
- actigraphy
2026
Viloxazine extended release improved ADHD, depression and anxiety symptoms in adults with comorbid conditions during a 14-week decentralised trial. The study demonstrates that remote monitoring via televisit, mobile app and home devices can deliver real-world efficacy and safety data for psychiatric medications.
Viloxazine Extended Release in Adults With Attention-Deficit/Hyperactivity Disorder and Depression and/or Anxiety Symptoms: Results From a Decentralized, Open-Label, Phase 4 Trial — Adler et al., The Journal of clinical psychiatry (paywalled)
- dct
- rpm
2026
A proof-of-concept decentralised trial generated 169 support tickets over 17 months from 90% of sites, with device-related problems accounting for 46% of requests. Most issues were resolved within three days and required two to six exchanges, demonstrating that robust technical support infrastructure is essential for successful remote monitoring and wearable-based trial conduct.
Toward Effective Technology Support in DCTs: Insights from the Trials@Home Proof-of-Concept Trial RADIAL — Weitlaner et al., Journal of medical systems
- dct
- wearable
- rpm
2026
Hybrid decentralized oncology trials are feasible in community hospitals beyond traditional networks, reducing logistical and financial burdens and enabling rapid initiation and patient referrals within three months.
Building HOPE: operationalizing hybrid decentralized oncology clinical trials with community providers beyond traditional healthcare system networks — Morrison et al., The oncologist
- dct
2026
A hybrid decentralised clinical trial using wearable dosing-monitoring and remote adverse-event reporting in healthy adults achieved 100% adherence with only 2% missing data, maintained adverse-event detection sensitivity, and was rated less burdensome than conventional on-site visits. These findings support the feasibility and reliability of participant-centric remote monitoring in early-phase pharmacokinetic studies.
Pioneering a Hybrid Decentralized Clinical Trial in South Korea: Assessing Feasibility, Data Integrity, and Participant Perceptions — Kim et al., Clinical and translational science
- dct
- wearable
- rpm
2026
Low-volume blood collection devices enable frequent, longitudinal sampling at home with reduced invasiveness, thereby improving participant retention in patient-centric studies. This facilitates decentralised biomarker monitoring for tracking disease progression and understanding physiological responses to diet, medication and physical activity.
Low-volume collection devices for longitudinal biomarker monitoring in patient-centric sampling settings — Simon-Guth et al., Bioanalysis (paywalled)
- blood
- self-collection
- validation
- dct
- biomarkers
2026
The study identified 48 strengths, 62 weaknesses, 5 opportunities, and 13 threats across eight key trial activities in decentralised clinical trials, highlighting potential advantages like remote participation and challenges such as digital technology barriers and privacy issues.
SWOT analysis of decentralised clinical trials from an ethical, legal, regulatory and operational perspective — Murciano-Gamborino et al., BMC medical ethics
- dct
2026
A nationwide survey of 194 professionals across 140 Japanese hospitals found that geographic and logistical barriers limit access to comprehensive genomic profiling and genotype-matched trials, with over half of eligible patients declining participation due to travel distance; most institutions support telemedicine for consent and results and view DCTs as essential to improve equitable access.
Bridging the distance in precision oncology: a nationwide survey on institutional perspectives toward telemedicine and decentralized trials in Japan — Taniguchi et al., International journal of clinical oncology
- dct
2026
A direct-to-participant, multichannel recruitment strategy enrolled 34,244 older adults into a virtual trial testing an Apple Watch based heart health programme with electrocardiogram and irregular rhythm notification features, achieving broad geographic and gender diversity but under-representing non-White ethnic groups.
Direct-to-Participant Enrollment in a Virtual Trial: Lessons Learned From the Heartline Study — Hills et al., JACC. Advances
- dct
- wearable
- rpm
- digital-biomarker
2026
This study found that most decentralised clinical trials are still focused on evaluating methods rather than fully implementing them, with digital tools often used to deliver study activities. The work highlights the need for stronger methodological validation, regulatory clarity, and attention to digital equity to advance decentralised diagnostics.
Decentralized clinical trials: A comprehensive analysis of trends, technologies, and global challenges — Kijewski et al., PLOS digital health
- dct
2026
Home spirometry gave slightly lower percent-predicted FEV1 values than office measurements cross-sectionally, but the three-month change in lung function did not differ significantly between settings. This suggests home spirometry can reliably detect treatment effects, supporting its use as an endpoint for decentralised cystic fibrosis trials.
Home Spirometry as a Clinical Trial Endpoint in People with Cystic Fibrosis: Results of the OUTREACH Study — Rosenfeld et al., Annals of the American Thoracic Society (paywalled)
- dct
- rpm
- digital-biomarker
2026
Analysis of six studies revealed that decentralised clinical trial elements enhanced data completeness by enabling direct access to medical records, although this introduced a significant burden for data abstraction. The results suggest that decentralised approaches are not a universal solution but provide specific metrics that can help design fit-for-purpose trials.
Measuring the added benefits of decentralized trial elements (SHASTA): impact on enrollment, demographics, and data completeness through a single sponsor — Yang et al., Scientific reports
- dct
2026
Experts achieved high consensus on recommendations to support decentralised clinical trials in Europe, including training for health care professionals, improving biological sample logistics, and fostering regulatory harmonization. These prioritized solutions aim to overcome barriers to adoption and create more inclusive and efficient research frameworks.
Addressing the Key Challenges of Decentralized Clinical Trials in Europe: Multistakeholder Perspective Delphi Study — Murciano-Gamborino et al., Journal of medical Internet research
- dct
2026
In a retrospective analysis of 444 metabolic disease trials, adoption of decentralised trial elements was not significantly associated with shorter trial duration after adjustment for clinical phase and characteristics. Phase 2 and 3 DCTs showed numerically shorter mean durations, but differences were not statistically significant, suggesting operational complexities may currently offset theoretical efficiency gains.
Association between decentralised clinical trial adoption and trial duration: a retrospective cross-sectional study of metabolic disease trials — Cho & Lee, BMJ open
- dct
2026
The study found that coached dried blood spot collection was feasible for remote biobehavioural assessment of CTRA gene expression among Black women activists, with usable data from 28 of 29 participants at baseline and 27 at follow-up. Within-person increases in activist identity and search for meaning were associated with more favourable CTRA gene expression changes, though mean CTRA did not shift across the group over the two-month period.
The paradox of action: Trajectories in distress, meaning, and gene regulation following self-directed activist engagement among Black women — Geyton & Cole, SSM. Mental health
- blood
- dried
- dbs
- self-collection
- dct
2026
This study demonstrated that a fully remote genome sequencing study using self-collected dried blood spots and buccal swabs is feasible for individuals with Prader-Willi syndrome, with all participants completing the study and reporting the process was easy despite being lengthy. The design successfully returned actionable genetic findings, including those related to blood clot formation, to participants.
Study design with responsible return of results for a fully remote genome sequencing study in individuals with Prader-Willi syndrome — Vrana-Diaz et al., Genetics in medicine open
- blood
- saliva
- dried
- dbs
- self-collection
- acceptability
- dct
- genotyping
2026
This narrative review surveys remote biospecimen collection products for sexual health research, including dried blood spots and volumetric absorptive microsampling, and concludes that successful implementation needs a multidisciplinary, participant-centred team with sufficient time allocated to the complexities of collection procedures and processes.
A Narrative Review of Remote Biospecimen Collection Product and Implementation Considerations for Sexual Health Clinical Research — Horvath et al., AIDS and behavior (paywalled)
- blood
- dried
- vams
- dbs
- self-collection
- validation
- dct
- serology
- sti
2025
Worked case studies of patient-centric sampling deployed in pharmaceutical drug development: how sponsors have implemented it, rather than whether it is possible.
Case Studies on the Use of Patient-centric Sampling for Clinical Studies in Pharmaceutical Drug Development — Patel et al., The AAPS Journal (paywalled)
- dct
- venous-agreement
- blood
- self-collection
- pediatric
- validation
- biomarkers
2025
A head-to-head pharmacokinetic comparison of conventional venous sampling against patient-centric microsampling: exactly the bridging study regulators now expect before microsampled data supports an endpoint.
A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient-Centric Microsampling — Shahin et al., Clinical and Translational Science
- dct
- venous-agreement
- blood
- dried
- capillary
- liquid
- validation
2025
A critical assessment of recent decentralised trial experience, weighing what the model has delivered against what was claimed for it.
Decentralized Clinical Trials in the Era of Real-World Evidence: A Critical Assessment of Recent Experiences — Wang et al., Clinical and Translational Science
- dct
- standards
- digital-biomarker
2025
A phase 1 trial designed around participant self-collection of pharmacokinetic samples at home, with video training and pre-assembled kits: evidence that the model is a training and logistics package, not only a device.
At-Home Self-Collection of Pharmacokinetic Data: Design and Results From a Phase 1 Open-Label Feasibility Trial — Raoufinia et al., Clinical Pharmacology in Drug Development
- dct
- neoteryx-mitra
- blood
- tdm
- self-collection
- dried
2025
A recommendation paper on extending decentralised elements in trials, covering the conditions under which trial activity, including biological sample collection, may take place away from the investigator site.
Recommendation Paper on Advancing the Use of Decentralised Elements in Clinical Trials — Bond et al., Therapeutic Innovation & Regulatory Science
- dct
- standards
2025
An evaluation of blood sampling strategies across a large UK healthcare-worker cohort study, covering how sampling approach affected participation.
Evaluating blood sampling strategies within the SIREN study: the experience from a large cohort of healthcare workers in the UK — Hettiarachchi et al., BMC Medical Research Methodology
- dct
- acceptability
- blood
- economics
- self-collection
- capillary
- validation
2025
A simulation of decentralised clinical trial elements at 11 Chinese investigational sites with 36 researchers found high satisfaction with direct-from-patient sample collection, although challenges remain regarding system ease of use and the integration of online and offline workflows.
Insights From a User Experience-Focused Virtual Study on the Feasibility and Challenges of Decentralized Clinical Trials — Ma et al., Clinical and translational science
- dct
- self-collection
2025
This trial found that decentralised saliva collection in care home residents with dementia is feasible, but only 66% of 1,014 samples were valid for alpha-amylase and 62% for cortisol assays. Sponsors should note the authors' caveat that future trials require improved collection protocols, such as stimulating saliva flow, to ensure data quality.
The short-term impact of music interventions on stress: Results of a multinational cluster-randomized trial using salivary cortisol and alpha-amylase assessments in care home residents with dementia — Rasing et al., Psychoneuroendocrinology (paywalled)
- dct
- cortisol
- liquid
- saliva
2025
This pilot study found that while initial household enrolment was low at 9%, remote follow-up was highly feasible, with 88% of respondents, 151 of 172, successfully returning self-collected capillary blood samples after 12 months. This shows that decentralised microsampling is viable for household cohorts when face-to-face contact is restricted.
'Bern, get ready', BEready, a household-based cohort study for pandemic preparedness research in Switzerland: pilot study — Hodel et al., BMJ open
- blood
- liquid
- capillary
- self-collection
- dct
2025
The study determined that using self-collected dried blood spots alongside online surveys was a feasible and acceptable method for remote pre-exposure prophylaxis adherence monitoring, with 64% of participants returning at least one blood specimen.
Remote pre-exposure prophylaxis adherence monitoring among young, Black men who have sex with men: a feasibility and acceptability pilot study — Jones et al., Current psychology (paywalled)
- dct
- acceptability
- blood
- dbs
- tdm
- self-collection
- dried
2025
In a one-week virtual home clinic with 134 participants, 86 per cent returned saliva and 84 per cent returned stool, and most components were feasible and acceptable despite device and logistical challenges. This supports decentralised, patient-centric self-collection of non-blood biospecimens for research.
Collecting at-Home Biometric Measures for Longitudinal Research From the i3C: Feasibility and Acceptability Study — Russell et al., JMIR human factors
- saliva
- stool
- self-collection
- acceptability
- dct
- microbiome
2025
The Trials@Home RADIAL trial's regulatory record across six European countries: early and continuous engagement with regulators made the decentralised elements possible, and harmonised guidance is still needed where national legislation differs.
Regulatory Interactions and Learnings-RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization — Gardarsdottir et al., Clinical pharmacology and therapeutics
- dct
- standards
2025
A study of older rural US patients found that 96 to 98 per cent of self-collected dried blood spot specimens were successfully analysed for HIV viral load, with high acceptability. However, concordance between self-reported and measured viral load was only 69 to 82 per cent, highlighting the value of objective decentralised microsampling over self-reporting.
Acceptability and Feasibility of Self-Collected Dried Blood Spot Specimens for Viral Load Monitoring among Rural Older People Living with HIV — Walsh et al., AIDS and behavior (paywalled)
- dct
- acceptability
- blood
- dbs
- self-collection
- dried
- serology
2025
In the RADIAL proof-of-concept trial in type 2 diabetes, run conventionally, hybrid and fully decentralised across five European countries, sites struggled at first with technology and participant onboarding despite proactive training; the authors conclude that decentralised conduct needs firm oversight and clear contracts with third-party providers.
Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities-Findings From the Trials@Home RADIAL Proof-of-Concept Trial — Lipinska et al., Clinical pharmacology and therapeutics
- dct
2025
A study of 292 patients found that the slopes of home-collected stimulated dried blood spot C-peptide levels over six months predicted 12-month venous mixed-meal tolerance test results, P<0.001. This shows decentralised microsampling can monitor beta-cell function, though further validation is required to confirm its reliability and broader applicability.
Early Detection of β-Cell Decline Using Home Dried Blood Spot C-Peptide Levels in New-Onset Type 1 Diabetes — Hendriks et al., Diabetes care (paywalled)
- dct
- venous-agreement
- blood
- dbs
- self-collection
- dried
- pediatric
- biomarkers
2025
A 2025 review from China finds decentralised trials still far from standard practice despite the enthusiasm of regulators and industry, and names the operational gaps that keep them so: technology, oversight and data quality.
Understanding the gap between expectations and reality in decentralized clinical trials — Jiang et al., NPJ digital medicine
- dct
2025
The study found that acoustic speech features differed significantly between Android and iOS devices, with iOS recordings showing more periodic content but less high-frequency energy, while Android devices exhibited greater measurement variability. These platform-specific differences, coupled with participant experience challenges such as iOS users struggling with background noise checks, demonstrate that device choice and app instruction design materially affect data quality and trial outcomes in decentralised digital biomarker studies.
Comparing Phoneme Speech Recordings and Acoustic App Data Capture Experience for Android and iOS Mobile Device Users in the Large Decentralized AcRIS Study — Chappie et al., Journal of voice : official journal of the Voice Foundation (paywalled)
- dct
- rpm
- digital-biomarker
2025
Interviews with clinical development staff found that decentralised clinical trials improved patient access by reducing travel burdens and waiting times. Implementation challenges included local regulations, telemedicine policies, IT infrastructure, information literacy and costs, with Japan lagging behind Europe and the United States in adoption.
Considerations on the implementation of DCT: a SCAT-based analysis of fact-finding interviews in Europe and the United States, with implications for regions newly adopting DCT, including Japan — Taruno et al., Frontiers in medicine
- dct
2025
A randomised trial of 47 participants using a mobile app integrated with remote patient monitoring devices achieved a 74% biomarker submission rate over four weeks, with system usability scores of 77–94 and acceptability exceeding benchmarks, showing the platform is feasible for remote data collection in decentralised clinical trials.
Evaluation of a remote biomarker capture system integrated with REDCap: A decentralized randomized trial — Dahne et al., Journal of clinical and translational science
- acceptability
- dct
- rpm
2025
This study found that a decentralised approach using home-based sleep apnoea screening, heart rhythm monitoring and activity tracking in patients with atrial fibrillation is feasible, with high data completeness and low drop-out rates. The results support the use of patient-centric digital tools in decentralised trials for chronic cardiac conditions.
Feasibility of a decentralised trial of sleep apnoea screening in patients with atrial fibrillation — Hashiba et al., Danish medical journal (paywalled)
- dct
- wearable
- rpm
- digital-biomarker
- actigraphy
2025
Decentralised clinical trials can help overcome barriers to trial participation such as travel burdens and improve access to recommended treatments.
[Decentralized Clinical Trials in Cancer Patients] — Sasaki & Nakamura, Gan to kagaku ryoho. Cancer & chemotherapy (paywalled)
- dct
2025
Remote motor assessment achieved a 95 percent completion rate and high caregiver acceptability in children with Canavan disease. Good to excellent inter- and intra-rater reliability demonstrates that rigorous remote assessment protocols can be implemented in decentralised trials for rare pediatric conditions, reducing burden on families.
Feasibility, Acceptability, and Reliability of Remote Motor Assessment in Children With Canavan Disease — Kiefer et al., Pediatric neurology (paywalled)
- pediatric
- dct
- rpm
- digital-biomarker
2025
This retrospective analysis found that trials using local labs had a lower percentage of white participants, while those using virtual visits had a lower percentage of Black participants. Wearables showed no significant demographic impact. These findings demonstrate that different decentralised trial components can have varying effects on participant diversity, which must be considered when designing equitable diagnostic studies.
Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials — Smith & Getz, Therapeutic innovation & regulatory science (paywalled)
- dct
2025
Participants and site personnel viewed the hybrid decentralised trial design favourably, though remote forced vital capacity assessments were more likely to be missed than in-clinic ones, and technological challenges were common.
Participant, site personnel and sponsor perspectives on decentralized trial features in COURAGE-ALS: a randomized clinical trial — Rudnicki et al., Amyotrophic lateral sclerosis & frontotemporal degeneration (paywalled)
- acceptability
- dct
2025
In a Phase 1 crossover study of etrasimod, self-collected blood microsamples yielded pharmacokinetic exposures comparable to conventional venous sampling, both with and without participant practice sessions. Continuous wearable sensors concurrently enabled real-time remote monitoring of safety vital signs and electrocardiograms, demonstrating the viability of hybrid decentralised designs in early-phase clinical trials.
Advancing Early Clinical Trials: The Transformative Potential of Decentralized Designs and Digital Technologies in Phase 1 Clinical Trial — Malhotra et al., Clinical pharmacology and therapeutics
- blood
- capillary
- self-collection
- venous-agreement
- dct
- wearable
- rpm
- digital-biomarker
- multimodal
2025
A fully decentralised trial of 9151 participants using a mobile app for daily voice capture found two machine learning algorithms met pre-specified success criteria for screening viral respiratory illness, with sensitivity increasing as symptoms increased while specificity remained consistent. This demonstrates voice-based digital biomarkers can identify infections remotely and validates bring-your-own-device trial designs.
Longitudinal voice monitoring in a decentralized Bring Your Own Device trial for respiratory illness detection — Santamaria et al., NPJ digital medicine
- dct
- rpm
- digital-biomarker
2025
WELT-I significantly improved sleep efficiency and reduced dysfunctional beliefs about sleep compared with a sham app in a decentralised clinical trial, supporting the feasibility of remote digital therapeutics for insomnia.
Validating the Efficacy of a Mobile Digital Therapeutic for Insomnia (WELT-I): Randomized Controlled Decentralized Clinical Trial — Park et al., Journal of medical Internet research
- dct
- digital-biomarker
2025
A large decentralised trial investigating a wearable device for COVID-19 detection retained 80.4% of participants at six months and 68.5% until completion. Multivariable analysis identified vaccinated pensioners as a high-risk discontinuation group, and targeted telephone calls reduced their dropout rate to 11.4%, showing that personalised retention strategies can improve engagement in remote diagnostic studies.
Increasing Retention in a Large-Scale Decentralized Clinical Trial: Learnings From the COVID-RED Trial — Zwiers et al., Mayo Clinic proceedings. Digital health
- dct
- wearable
- rpm
2025
This literature review maps the regulatory landscape for decentralised clinical trials across the US, EU and China, finding that the US emphasises efficiency and technological integration, the EU prioritises equity and patient engagement, and China focuses on rare diseases with a cautious regulatory approach. It argues that fragmented governance across jurisdictions hampers the full realisation of DCTs and calls for greater international harmonisation.
The status quo of the development of decentralized clinical trials — Chen et al., Frontiers in medicine
- dct
2025
A programmatic architecture for remote decentralised clinical trials in atrial fibrillation successfully enrolled 513 participants across rural and metropolitan settings, with 89 percent retention at 12 months and sustained engagement with a smartphone-based adherence intervention. The approach reached diverse populations including 62 percent women and 44 percent with limited health literacy, demonstrating feasibility of patient-centric remote monitoring for cardiovascular research.
Augmenting Engagement in Decentralized Clinical Trials for Atrial Fibrillation: Development and Implementation of a Programmatic Architecture — Omole et al., JMIR cardio
- dct
- rpm
2025
Home-based ECG and blood pressure monitoring in 3,820 elderly hypertensive patients detected undiagnosed atrial fibrillation in 5.8 per cent over three months. The detection rate was not significantly associated with baseline blood pressure category, measurement frequency, or antihypertensive medication use, indicating that broad screening may be warranted regardless of blood pressure control.
Relationship Between Screening-Detected Atrial Fibrillation and Blood Pressure Levels in Elderly Hypertensive Patients: The OMRON Heart Study — Senoo et al., Thrombosis and haemostasis
- dct
- rpm
- digital-biomarker
2025
Healthy older adults performed similarly on functional capacity tests whether delivered by computer or cloud-based tablet, with only a five per cent speed improvement on the iPad version of one test. This supports the feasibility of migrating digital clinical assessments to remote cloud-based delivery for decentralised trials without compromising validity.
Migration of digital functional capacity assessments from device resident to cloud-based delivery: Development and convergent validity — Harvey et al., Schizophrenia research. Cognition
- dct
- digital-biomarker
2025
The RADIAL proof-of-concept trial delivered investigational medicinal products directly to participants with a 94 percent success rate across six European countries, though drop-off of biological samples was more challenging in the fully remote arm. Key obstacles included regulatory divergence, unclear vendor responsibilities, and unreliable sample collection, showing that decentralised trials need robust logistics, temperature control, and participant training to ensure safety and data integrity.
The Supply of Investigational Medicinal Product and Management of Study Materials for Decentralized Participants-Insights from the Trials@Home RADIAL Proof-of-Concept Trial — Heath et al., Clinical pharmacology and therapeutics
- dct
2025
Targeted proteomic evaluation of a novel finger-prick dried plasma device demonstrated strong quantitative correlation with conventional plasma (R = 0.99) and precision under 10% CV for 80% of quantified peptides across healthy donors. Quantified targets also remained stable during room temperature storage for up to 232 days, supporting its use for decentralised biomarker monitoring.
Quantitative Assessment of a Novel Device Designed for Patient-centric Sampling of Dried Plasma Using Targeted Proteomics — Hober et al., Analytical chemistry
- blood
- dried
- capillary
- self-collection
- validation
- venous-agreement
- dct
- biomarkers
2025
Long-term sleep quality improved significantly during an internet-based intervention for major depressive disorder. Patients with poor sleep initially showed blunted cortisol awakening responses, which normalised as sleep quality improved, demonstrating that self-collected saliva can track biological stress changes in decentralised mental health care.
Sleep quality and the biological stress system during an internet-based intervention for major depressive disorder — Laufer et al., Comprehensive psychoneuroendocrinology
- saliva
- self-collection
- hormones
- cortisol
- dct
2025
In 50 cancer patients monitored at home with an Apple Watch for 28 days, a method that classified missing step data by gap duration and context produced the most reliable daily step estimates. Daily step counts on days with at least ten hours of wear time predicted time to first clinical event (p=0.068) and identified participants at lower hazard of mortality, with 83.3% accuracy for clinical event prediction, demonstrating that processed consumer wearable data can support remote monitoring in decentralised oncology trials.
Analysis Method of Real-World Digital Biomarkers for Clinical Impact in Cancer Patients — Oakley-Girvan et al., Digital biomarkers
- oncology
- dct
- wearable
- digital-biomarker
- actigraphy
2025
In this decentralised trial of 899 adults with asthma, participants using a digital self-management programme with wearable device integration showed a 4.6-point gain on the Asthma Control Test at 12 months relative to usual care. This provides evidence that remote digital interventions can achieve clinically significant improvements in asthma control without in-person visits.
A Digital Asthma Self-Management Program for Adults: A Randomized Clinical Trial — Silberman et al., JAMA network open
- dct
- wearable
- rpm
- digital-biomarker
2025
A qualitative study of Danish policy stakeholders found that conflicting interests across patient, healthcare, industry and political groups create paradoxical tensions that obstruct efficient implementation of decentralised clinical trials. Resolving these tensions and assigning clear implementation responsibility are necessary for sustainable adoption of decentralised diagnostics.
Exploring implementation challenges of decentralized clinical trials: A qualitative study of policy stakeholder perspectives in Denmark — Hestbjerg et al., Digital health
- dct
2025
In surveys of 141 trial-site staff and 481 individuals, participants showed greater enthusiasm for hybrid and remote decentralised trials than site staff, who worried about burden, trust and security. Participant willingness to use trial technologies decreased with rising perceived burden, underscoring that practical support is vital for adoption in decentralised diagnostics.
Comparison of Participant and Site Perceptions of Decentralized Clinical Trials in the USA — Barge & Floody, Mayo Clinic proceedings. Digital health
- acceptability
- dct
2025
The analysis highlights that leveraging digital health technologies and decentralised clinical trials can improve evidence generation and access in rare disease drug development, offering more efficient and inclusive processes where traditional approaches are limited.
Addressing global regulatory challenges in rare disease drug development — Costa et al., Drug discovery today (paywalled)
- dct
- digital-biomarker
2025
The study found that decentralised trial participants were more representative than conventional trial participants in terms of age, insulin use, smoking status and body mass index, suggesting that decentralised approaches can improve demographic and clinical diversity in trials. This matters because better representativeness enhances the generalisability of trial results to real-world patient populations.
The impact of operational trial approaches on representativeness: Comparison of decentralized clinical trial participants, conventional trial participants, and patients in daily practice — de Jong et al., Drug discovery today (paywalled)
- dct
2025
Participants in the ACTIV-6 decentralised trial viewed remote procedures supported by digital health technologies as acceptable and efficient for organising study activities, communicating with study personnel and managing medications at home, though social media recruitment raised concerns about trust and study legitimacy that future trial designs should address.
Participant experiences in a decentralized clinical trial using digital health technologies: The ACTIV-6 study — Reale et al., Journal of clinical and translational science
- acceptability
- dct
2025
In a fully remote decentralised clinical trial of a mobile mental health intervention, 62% of eligible screeners were fraudulent, detected most commonly by duplicate identifiers and VPN or proxy detection, with social media recruitment yielding a higher fraud rate of 85% compared with 26% from survey panels.
Mitigating fraud in a fully decentralized clinical trial of a digital health intervention — Moore et al., Annals of behavioral medicine : a publication of the Society of Behavioral Medicine (paywalled)
- dct
2025
In this decentralised n-of-1 crossover trial of dapagliflozin in 20 adults with type 2 diabetes, remote collection of urine and capillary blood samples achieved 99.4% and 98.4% delivery success respectively, demonstrating that remote monitoring can reliably track individual albuminuria responses to therapy.
Albuminuria Responses to Dapagliflozin in Patients With Type 2 Diabetes: A Crossover Trial — Beernink et al., JAMA network open
- blood
- urine
- capillary
- self-collection
- dct
2025
In a decentralised phase 1 trial, healthy adults used a clinical trial app to self-collect blood microsamples and vital signs at home, with 65 to 70 per cent successfully providing blood samples and most preferring self-collection over staff collection.
Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals — Ye et al., Contemporary clinical trials communications
- blood
- self-collection
- acceptability
- dct
- rpm
- multimodal
2025
The study found that while decentralised clinical trials improve accessibility, they introduce complexities that can negatively affect patient engagement and the relationship between staff and participants due to limited interaction frequency and quality.
Adaptation of Clinical Research Staff to Decentralized Clinical Trials and Impacts on the Patient-Centered Experience: Qualitative Interview Study — Gamble et al., Journal of medical Internet research
- acceptability
- dct
2025
In a decentralised trial of 108 pulmonary fibrosis patients, a nine-week digital cognitive behavioural therapy programme reduced GAD-7 anxiety scores by 2.7 points more than treatment as usual (p=0.0006). This shows decentralised digital interventions can deliver clinically significant psychological benefit in chronic respiratory disease, supporting remote patient management.
A digital therapy targeting anxiety in pulmonary fibrosis: A decentralized randomized controlled trial — Solomon et al., Respirology
- dct
- digital-biomarker
2025
In 22 adults, capillary blood collection demonstrated strong correlation with venous sampling for 66 per cent of inflammatory proteins and moderate to strong correlation for 80 per cent overall, supporting its validity for proteomic measurement in decentralised trials.
Comparing Venous vs. Capillary Blood Collection Methods for Proteomic Measurement in Peripheral Blood — Ni Lochlainn et al., Proteomics. Clinical applications
- blood
- capillary
- validation
- venous-agreement
- dct
- biomarkers
2025
The authors outline that FDA supports decentralised clinical trials to boost participation, noting that while they offer convenience for participants, successful implementation requires careful coordination, remote supervision, training, and risk management. This matters because it establishes the regulatory context and operational considerations for deploying patient-centric microsampling and remote monitoring in drug development.
Decentralized Clinical Trials in the Development of Drugs and Biological Products — Robinson & Sacks, Therapeutic innovation & regulatory science
- dct
2025
During COVID-19, 95% of cancer trial sponsors adopted decentralised elements, with remote laboratory assessments used in 63% of trials, demonstrating that such methods can generate FDA-approvable data. Sponsors reported institutional policies as the main barrier, yet most plan to continue remote monitoring and telemedicine, indicating sustained viability for reducing patient burden.
Adoption of Decentralized Trial Elements in Cancer Clinical Trials Supporting FDA Approvals during COVID-19 — Patel et al., Clinical cancer research : an official journal of the American Association for Cancer Research (paywalled)
- oncology
- dct
2025
The RADIAL proof-of-concept trial demonstrated that a modular, multi-vendor technology package can operationalise decentralised clinical trials, but revealed significant challenges with Bring Your Own Device variability, immature device technologies, and clinical site infrastructure limitations. Investing in participant support infrastructure, automated multichannel notifications, and early cross-functional compliance planning enhanced participant engagement and streamlined governance, reducing burden.
Operationalizing Decentralized Clinical Trials: Technology Insights from the Trials@Home RADIAL Proof-of-Concept Trial — Hanke et al., Clinical pharmacology and therapeutics
- dct
- rpm
2025
The article outlines the benefits and operational strategies for decentralised clinical trials, emphasising that remote participation improves access and convenience. It argues that making trials participant centric through intentional recruitment and engagement can accelerate scientific discovery and build trust in the research process.
Participants as Partners in Decentralized Clinical Trials — Harris & Cheng, NEJM evidence (paywalled)
- dct
2025
Clinical trial practitioners in China generally understand decentralized clinical trials and are willing to participate, although they lack practical experience and identify technical barriers and data reliability as the main challenges to implementation.
Study on knowledge, practices, and attitudes toward decentralized clinical trials among the clinical trial practitioners in China — Shi et al., Frontiers in medicine
- dct
2025
In 55 patients, four approaches to convert dried capillary blood concentrations to plasma equivalents were evaluated. All methods except haematocrit-based conversion yielded acceptable analytical and clinical agreement for paracetamol and metabolites, supporting the reliability of capillary microsampling for decentralised therapeutic drug monitoring.
Comparative Evaluation of Approaches to Convert Microsampled Capillary Blood Concentrations to Plasma Concentrations: Paracetamol and Metabolites as a Case Study — Boffel et al., The AAPS journal (paywalled)
- blood
- dried
- capillary
- vams
- neoteryx-mitra
- validation
- venous-agreement
- dct
- haematocrit
2025
In a fully virtual decentralised trial of 2516 participants with mild asthma, as-needed albuterol-budesonide cut the risk of severe exacerbation by 47 per cent compared with albuterol alone (hazard ratio 0.53). The trial shows that decentralised designs can deliver robust event-driven outcomes for respiratory disease without traditional site visits.
As-Needed Albuterol-Budesonide in Mild Asthma — LaForce et al., The New England journal of medicine (paywalled)
- dct
2024
At-home capillary microsampling carried pharmacokinetic sampling across the Paxlovid phase II/III programme, with fewer than 3% of more than 800 samples unusable, and the resulting data supported the Emergency Use Authorization and subsequent FDA approval: remotely collected samples accepted in a registrational filing.
Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation — Wan et al., Clinical Pharmacology & Therapeutics (paywalled)
- dct
- volumetric
- venous-agreement
- blood
- self-collection
- dried
- capillary
- validation
2024
In children, stool preserved in OMNIgene-GUT kept its microbial community structure better than unpreserved stool, with alpha and beta diversity similar to direct freezing, which supports the kit for decentralised stool collection from children.
Omnigene-Gut<sup>tm</sup> ensures fecal microbiome stability in the pediatric population — Hoogendijk et al., AMB Express
- dct
- stabilised
- dna-genotek-omnigene
- microbiome
- pediatric
- stool
- validation
2024
In 102 patients, Mitra and Capitainer microsamples gave urine albumin-to-creatinine ratios at 102% and 95% of the clinical analyser's, and both stayed within 98% to 103% after three weeks at room temperature, which supports either device for decentralised urine collection.
Patient-Centric Quantitative Microsampling for Accurate Determination of Urine Albumin to Creatinine Ratio (UACR) in a Clinical Setting — Löfgren et al., The journal of applied laboratory medicine (paywalled)
- dct
- volumetric
- neoteryx-mitra
- urine
- validation
- biomarkers
2024
A decentralised trial in Singapore found 97% participant retention and high sample collection rates. Participants reported convenience and safety, while reduced travel lowered environmental impact compared to traditional trials.
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) — Fries et al., Frontiers in public health
- dct
- acceptability
2024
The review highlights that decentralized clinical trials can improve inclusivity and efficiency by overcoming geographical and logistical barriers through remote digital technologies, though challenges remain regarding data security, privacy, and regulatory standardisation.
The value of decentralized clinical trials: Inclusion, accessibility, and innovation — Jean-Louis & Seixas, Science (paywalled)
- dct
2024
Decentralised recruitment channels generated 97.5% of enrolments, were cost effective, and met timelines, with 82.6% retention at six months, showing that decentralised strategies are feasible and conducive to achieving enrolment targets.
Recruitment, Retention, and Participant Diversity in the Context of a Heart Failure Self-Care Digital Intervention Decentralized Clinical Trial — West et al., AMIA ... Annual Symposium proceedings. AMIA Symposium (paywalled)
- dct
2024
A national steering committee developed twelve standard operating procedures and a supervision plan to guide decentralised cancer clinical trials in New Zealand with an equity focus. This patient-centred approach allows patients to stay in their local areas with their support networks, improving trial accessibility.
Process of development of decentralised clinical trial methodology for cancer clinical trials in Aotearoa New Zealand — Lawrence et al., The New Zealand medical journal (paywalled)
- dct
2024
Preliminary data from the HOT4PrEP trial show 67% of participants offered home-based PrEP monitoring chose to self-collect blood and STI samples at home, and 82% of these successfully returned kits. This demonstrates feasibility and acceptability of decentralised microsampling for HIV prevention, which may improve PrEP retention and expand clinical capacity.
Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: Protocol for a Randomized Controlled Trial — Cannon et al., JMIR research protocols
- blood
- self-collection
- acceptability
- dct
- sti
2024
The study found that distance to the study institution was a significant barrier to enrollment in a prehabilitation trial for advanced ovarian cancer patients, with fewer enrolled patients living 200 miles or more away compared to those not enrolled, supporting the need for decentralised clinical trials.
An Argument for Decentralized Clinical Trials in Gynecologic Oncology — Mokshagundam et al., O&G open
- oncology
- dct
2024
Decentralised clinical trials conducted in home environments shift substantial logistical and procedural responsibilities onto caregivers of cancer patients. Addressing digital literacy barriers, sample handling workflows, and inadequate support is essential to prevent excessive caregiver burden during remote trial execution.
Decentralized Clinical Trials at Home: Commentary on Caregivers' Burden — Bolajoko et al., Cancer control : journal of the Moffitt Cancer Center
- oncology
- dct
2024
This randomised trial found that peer-delivered HIV self-testing and sexually transmitted infection self-sampling did not improve oral pre-exposure prophylaxis adherence among transgender women in Uganda compared to standard care. Adherence was monitored using dried blood spots and urine, which showed a strong correlation in tenofovir detection.
Peer-Delivered HIV Self-Testing, Sexually Transmitted Infection Self-Sampling, and Pre-exposure Prophylaxis for Transgender Women in Uganda: A Randomized Trial — Mujugira et al., Journal of acquired immune deficiency syndromes
- blood
- saliva
- urine
- dbs
- self-collection
- tdm
- dct
- sti
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