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 101–183 of 183 labelled “dct”, newest first.
2024
A scoping review identified twelve studies comparing remote and in-person administration of the ALS Functional Rating Scale-Revised. While correlations between modes were high, the evidence remains insufficient to endorse remote clinician administration for high-quality data in decentralised ALS trials.
Remote-Use Applications of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised Clinical Outcome Assessment Tool: A Scoping Review — Bhushan et al., Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research (paywalled)
- dct
- rpm
2024
A survey of 355 clinical research sites found that half had no experience with decentralised trial solutions and only 6.6% had run a fully decentralised trial. Half of respondents viewed decentralised approaches as more burdensome than traditional trials, particularly for clinical procedures requiring staff–patient interaction, indicating that reducing site burden is critical for adoption of decentralised diagnostics.
Quantifying Site Burden to Optimize Protocol Performance — Florez et al., Therapeutic innovation & regulatory science (paywalled)
- dct
2024
A digital decentralised clinical trial platform for long COVID successfully managed e-consent, randomisation, and data capture, but faced significant challenges including recruitment difficulties, imposter participants, and high attrition rates. These findings highlight critical considerations for designing viable remote trials in complex syndromes.
Key considerations for digital decentralised clinical trials from a feasibility study assessing pacing interventions for long COVID — McMullan et al., Scientific reports
- dct
2024
A statewide remote seroprevalence study using at-home dried blood spot kits achieved a 71.6% sample return rate from registered households, with success dependent on integrated data systems, responsive participant support, and strong health department partnerships. This demonstrates feasibility of large-scale decentralised microsampling for public health surveillance.
CalScope: methodology and lessons learned for conducting a remote statewide SARS-CoV-2 seroprevalence study in California using an at-home dried blood spot collection kit and online survey — Lim et al., BMC medical research methodology
- blood
- dried
- dbs
- self-collection
- dct
- serology
2024
A dried urine spot method for measuring 14 amino acids was validated using filter paper and mass spectrometry, offering a stable alternative to liquid urine that supports patient self-collection and remote analysis.
Dried urine spot (DUS) applied for sampling prior to the accurate HILIC-MS/MS determination of 14 amino acids — Meikopoulos et al., Talanta (paywalled)
- urine
- dried
- validation
- dct
2024
A modified Delphi consensus panel developed 40 pragmatic recommendations to guide the delivery of decentralised clinical trials for dementia risk-reduction medications. The guidance outlines necessary safety balances, dispensing protocols, outcome assessments, and remote data collection methods.
Decentralized clinical trials for medications to reduce the risk of dementia: Consensus report and guidance — Howard et al., Alzheimer's & dementia : the journal of the Alzheimer's Association
- dct
- standards
2024
When patiromer is taken three hours after tacrolimus, it does not alter tacrolimus exposure in kidney transplant recipients. The study also shows that self-collected capillary blood samples using volumetric absorptive microsampling (VAMS) can reliably measure tacrolimus concentrations, which simplifies pharmacokinetic studies and enables decentralised therapeutic drug monitoring.
Patiromer Does Not Alter Tacrolimus Pharmacokinetics in Kidney Transplant Recipients When Administered Three Hours Post-Tacrolimus — Drevland et al., Transplantation direct
- blood
- dried
- capillary
- vams
- neoteryx-mitra
- self-collection
- tdm
- immunosuppressants
- dct
2024
Microsampling enables home-based specimen collection for drug development and clinical trials, reducing patient burden and expanding enrolment diversity, but requires bridging studies to ensure data comparability with conventional methods and faces analytical challenges that LC-MS strategies aim to address.
Enhancing drug development and clinical studies with patient-centric sampling using microsampling techniques: Opportunities, challenges, and insights into liquid chromatography-mass spectrometry strategies — Chen et al., Journal of mass spectrometry : JMS (paywalled)
- validation
- dct
- standards
2024
A fully remote phase II trial in major depressive disorder was terminated early due to poor recruitment but demonstrated feasibility with a 97.7% completion rate and 88% positive patient experience, highlighting the need to optimise eligibility criteria and recruitment strategies for future decentralised interventional studies.
Safety of BI 1358894 in patients with major depressive disorder: Results and learnings from a phase II randomized decentralized clinical trial — Reist et al., Clinical and translational science
- dct
2024
The article identifies enhanced accessibility, participant diversity and research efficacy as benefits of decentralised clinical trials in asthma, while noting concerns around regulatory compliance and data privacy. It concludes that mHealth-enabled decentralised studies are a feasible step toward improving equity in allergy and immunology research.
Enhancing asthma research and improving health equity through decentralized clinical trials (DCTs) and mHealth technology — Hunt et al., The Journal of asthma : official journal of the Association for the Care of Asthma (paywalled)
- dct
2024
BATURA is a fully decentralised, phase 3b, randomised, double blind study comparing as needed albuterol budesonide with albuterol alone in mild asthma, with all visits conducted virtually and study medication shipped to participants; medication use is captured by a digital sensor and the primary endpoint is time to first severe asthma exacerbation, enabling assessment of efficacy while reducing participant burden and improving access.
A Fully Decentralized Randomized Controlled Study of As-Needed Albuterol-Budesonide Fixed-Dose Inhaler in Mild Asthma: The BATURA Study Design — LaForce et al., Journal of asthma and allergy
- dct
- digital-biomarker
2024
Capillary blood collection using liquid and dried microsampling devices yielded pharmacokinetic profiles comparable to venous sampling for two monoclonal antibodies and a small molecule, whereas haematocrit correction was necessary for dried formats and bridging was ineffective for hydroxychloroquine. The findings demonstrate the bioanalytical feasibility and patient acceptability of remote microsampling tools for pharmacokinetic evaluations in decentralised clinical trials.
Evaluation of Patient-Centric Sample Collection Technologies for Pharmacokinetic Assessment of Large and Small Molecules — Mandlekar et al., Clinical pharmacology and therapeutics (paywalled)
- blood
- liquid
- dried
- capillary
- neoteryx-mitra
- validation
- venous-agreement
- acceptability
- tdm
- biologics
- dct
- haematocrit
2024
Low volume sampling devices showed good concordance with venous serum for measuring the pharmacodynamic biomarker sMAdCAM-1, but dried blood samples required substantial dilution to overcome buffer interference, which was mitigated by using a highly sensitive Simoa assay. The study demonstrates that while these devices have potential for decentralised clinical trials, careful validation is needed to address site-specific biases and assay sensitivity limitations.
Evaluation of low volume sampling devices for a pharmacodynamic biomarker analysis: Challenges and solutions — Yang et al., Journal of pharmaceutical and biomedical analysis (paywalled)
- blood
- liquid
- dried
- neoteryx-mitra
- validation
- venous-agreement
- dct
- biomarkers
2024
This decentralised clinical trial demonstrated that home-delivered meals tailored to laboratory findings significantly stabilised serum phosphorus levels and improved nutritional status in haemodialysis patients.
Adaptive Nutrition Intervention Stabilizes Serum Phosphorus Levels in Hemodialysis Patients: A Multicenter Decentralized Clinical Trial Using Real-World Data — Chung et al., Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation (paywalled)
- blood
- dct
2024
Flexibility of location and time were the most motivating factors for people with type 2 diabetes to participate in decentralised clinical trials. Digital infrastructure, literacy, home visits, personal interaction, and healthcare professional relationships could be either enablers or barriers depending on individual preferences, suggesting these must be addressed in trial design.
What motivates people with type 2 diabetes mellitus to participate in clinical trials from home? — Kopanz et al., Clinical and translational science
- acceptability
- dct
2024
Among 1,423 people who use drugs across 21 community centres, a decentralised care programme using dried blood spot testing achieved a 93% cure rate in those who completed hepatitis C therapy and were monitored. Over 90% of participants accepted the decentralised screening and treatment approach, showing patient-centric microsampling can improve healthcare access for stigmatised populations.
Implementing a new HCV model of care for people who use drugs — Herranz Mochales et al., JHEP reports : innovation in hepatology
- blood
- dried
- dbs
- acceptability
- dct
- serology
2024
The survey of 80 clinical research stakeholders in India highlights the growing adoption of remote data capture, wearables, and digital biomarkers in decentralized clinical trials, driven by the COVID-19 pandemic, while also identifying key challenges that need to be addressed for wider implementation.
The role of remote data capture, wearables, and digital biomarkers in decentralized clinical trials — Chodankar et al., Perspectives in clinical research
- dct
- wearable
- rpm
- digital-biomarker
2024
The authors propose applying the ICH E9(R1) estimand framework to decentralised clinical trials to systematically evaluate each decentralisation component. This approach reveals how off-site data collection changes the scientific questions being addressed, exposing both new opportunities and hidden assumptions that affect trial validity.
Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework — Izem et al., Therapeutic innovation & regulatory science (paywalled)
- dct
2024
Self-collected dried blood spots were used to assess HIV status at 12 months in 1168 participants. Integration of sexual and reproductive health services increased linkage to HIV prevention care within 60 days (adjusted odds ratio 1·68) compared with standard referral, whereas peer support had no effect.
Effectiveness of integrating HIV prevention within sexual reproductive health services with or without peer support among adolescents and young adults in rural KwaZulu-Natal, South Africa (Isisekelo Sempilo): 2 × 2 factorial, open-label, randomised controlled trial — Shahmanesh et al., The lancet. HIV (paywalled)
- blood
- dried
- dbs
- self-collection
- dct
- serology
- sti
2024
Interviews with European health technology assessment representatives showed that while decentralised clinical trial models offer real-world relevance and reduced recall bias, concerns persist regarding data quality when trial participants manage data collection independently.
Opportunities and Challenges for Decentralized Clinical Trial Approaches: European Health Technology Assessment Perspective — de Jong et al., Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research (paywalled)
- dct
- economics
2024
This analysis of regulatory guidance and 4,874 registered trials found that decentralised clinical trials have grown annually, especially after 2020, with most involving simple behavioural and technological interventions rather than drug studies. Both the FDA and EMA emphasised patient safety and data integrity as the two axes for assessing decentralised elements, and the trial landscape aligned with these recommendations by predominantly using low-risk, previously approved oral drugs.
The landscape of decentralized clinical trials (DCTs): focusing on the FDA and EMA guidance — Park et al., Translational and clinical pharmacology
- dct
2024
Brief spontaneous speech analysis using machine learning can accurately identify individuals with Alzheimer's dementia and mild cognitive impairment and predict performance across attention, memory, executive function, language and visuospatial domains, supporting its use for remote screening and disease monitoring.
Unveiling the sound of the cognitive status: Machine Learning-based speech analysis in the Alzheimer's disease spectrum — García-Gutiérrez et al., Alzheimer's research & therapy
- dct
- digital-biomarker
2024
A survey of eight biopharmaceutical companies, representing a third of the oncology market, revealed that remote monitoring adoption in oncology trials trails other therapeutic areas. Electronic diaries and digital clinical outcome assessments are the most deployed tools, while local physician network visits are least used; respondents expect adoption to rise by over 40% for most technologies within five years, with digital recruitment and local imaging prioritised for improving patient centricity.
Remote Monitoring and Data Collection for Decentralized Clinical Trials — Daly et al., JAMA network open
- dct
- rpm
2024
Adolescents collecting blood microsamples at home achieved varying success rates across six devices, with Minicollect tubes performing poorest. The confirmation that visual inspection alone was insufficient, by analytical variability, underscores the need for robust quality assessment before deploying any device in decentralised trials.
Self-Sampling by Adolescents at Home: Assessment of the Feasibility to Successfully Collect Blood Microsamples by Inexperienced Individuals — Boffel et al., The AAPS journal (paywalled)
- blood
- liquid
- dried
- capillary
- vams
- dbs
- neoteryx-mitra
- self-collection
- acceptability
- pediatric
- dct
2023
An expected net present value model found that decentralised clinical trials in phases II and III increase drug value by an average of $20 million, yielding a seven-fold return on investment. However, the authors caution that larger datasets and broader operational coverage are needed to validate these findings.
Assessing the Financial Value of Decentralized Clinical Trials — DiMasi et al., Therapeutic Innovation & Regulatory Science
- dct
- economics
2023
A systematic review of 13 decentralised studies: 11 reported recruitment success with approaches departing from site-based methods, and 7 reported success retaining participants. The recruitment finding largely reflects remote outreach rather than remote sampling specifically.
Methods and perceptions of success for patient recruitment in decentralized clinical studies — Miyata et al., Journal of Clinical and Translational Science
- dct
- acceptability
2023
Over three years after HPV vaccination in 58 women, HPV-specific IgG was detected in 84% to 100% of first-void urine samples against 98% to 100% of serum samples, and the two correlated strongly; the authors support self-collected urine for follow-up of vaccine-induced immunity, with the caveat that only women were studied.
Follow-up of humoral immune response after HPV vaccination using first-void urine: A longitudinal cohort study — Téblick et al., Journal of medical virology (paywalled)
- dct
- colli-pee
- first-void
- serology
- hpv
- urine
2023
The COVID-OUT trial showed a fully decentralised, multicentre randomised trial could be completed with only 1.4% loss to follow-up using electronic consent, prepackaged investigational product, and remote outcome confirmation. This demonstrates decentralised trials can achieve high retention without in-person contact, directly informing decentralised diagnostic study design.
Strategies used for the COVID-OUT decentralized trial of outpatient treatment of SARS-CoV-2 — Avula et al., Journal of clinical and translational science
- dct
2023
In a 16-donor validation study, prompt centrifugation of serum microsamples maintained analyte stability and preserved clinical chemistry and protein biomarker quality. This demonstrates that remote centrifugation with refrigerated shipping can lessen patient burden and broaden participation in decentralised clinical trials.
Decentralized clinical trial design using blood microsampling technology for serum bioanalysis — Lee et al., Bioanalysis (paywalled)
- blood
- liquid
- validation
- venous-agreement
- dct
- biomarkers
2023
A remote protocol combining daily surveys with weekly self-collected dried blood spots achieved a 92% study completion rate and high acceptability among reproductive-age women smokers, with 87% of participants collecting most samples and the same proportion extremely willing to repeat the study. This feasibility demonstrates that decentralised microsampling can support longitudinal research on hormonal contraceptive effects and smoking behaviour.
Feasibility of remotely assessing hormonal contraceptive use and smoking-related symptomatology: Evidence from a preliminary prospective cohort study — Medvescek & Allen, Drug and alcohol dependence reports (paywalled)
- blood
- dried
- dbs
- self-collection
- acceptability
- fertility
- hormones
- dct
2023
The study found that smartwatch-based adherence monitoring showed consistent concordance over time and may be more reliable than app or pill count methods in measuring treatment adherence in a decentralised setting. This supports the use of wearable devices as objective tools in patient-centric monitoring for decentralised clinical trials.
Exploration of smart adherence-monitoring methods in vitamin D-deficient patients: A pilot feasibility clinical study — Huh et al., Clinical and translational science
- blood
- dct
- wearable
- digital-biomarker
- multimodal
2023
The study found that blood concentrations of padsevonil measured using Mitra devices can reliably predict plasma concentrations with less than 9% mean bias, supporting the use of VAMS as a patient-centric alternative to venous sampling in decentralised trials. This validation strengthens confidence in microsampling for therapeutic drug monitoring where venous draws are impractical.
Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development — Kramer et al., The AAPS journal (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- venous-agreement
- tdm
- dct
2023
The study found that noninternet participants in a decentralised trial were older, from more diverse backgrounds, and had worse health outcomes and higher nonadherence rates than internet participants. This matters because it shows that allowing noninternet participation increases diversity but may require additional support to maintain adherence and retention in decentralised trials.
Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study — Shen et al., Journal of the American Heart Association
- dct
2023
Remote decentralised clinical trials can improve patient retention and generalisability by bringing trial activities closer to participants' homes using digital technologies. This matters for decentralised diagnostics as it supports the shift towards patient-centric models that reduce the need for on-site visits and broaden patient inclusion.
Remote decentralized clinical trials: a new opportunity for laboratory medicine — Pennestrì et al., Clinical chemistry and laboratory medicine (paywalled)
- dct
2023
The authors developed a capillary microfluidic device that captures multiple blood biomarkers at collection and dries them on-chip, enabling safe shipment to centralised laboratories for multiplexed analysis. This patient-centric approach could support remote health monitoring and decentralised trials.
Microfluidic Device for Patient-Centric Multiplexed Assays with Readout in Centralized Laboratories — Hauser et al., Analytical chemistry
- blood
- dried
- capillary
- dct
- biomarkers
2023
The CHIEF-HF trial showed a fully decentralised, placebo-controlled heart failure trial can run without in-person visits, yet recruitment remained challenging: just 2.0% of 130,832 contacted people expressed interest, and 18.5% of those were enrolled. At the highest-enrolling site, electronic medical record portal messaging yielded higher opt-in rates than email alone (7.8% versus 4.4%), suggesting targeted digital channels can improve participation in decentralised diagnostic studies.
Recruitment Strategies of a Decentralized Randomized Placebo Controlled Clinical Trial: The Canagliflozin Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) Trial — Nassif et al., Journal of cardiac failure (paywalled)
- dct
- digital-biomarker
2023
A fully remote, randomised pilot trial of 30 people with functional constipation demonstrated geographic reach with 27% residing outside metropolitan areas. Lactobacillus supplementation increased weekly bowel movements by 0.80 and reduced defecation time by 3.94 hours versus vitamin C alone, but 33% of mobile diary entries were not completed as scheduled, highlighting the need for real-time data quality monitoring in decentralised trials.
Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms — Huh et al., Clinical and translational science
- dct
- digital-biomarker
2023
The authors developed and deployed a decentralised trial platform for a Phase 2 COVID-19 study that used home-based monitoring devices and mobile applications to collect health data remotely, enabling inclusion of participants from diverse socioeconomic backgrounds and rural settings. They created a Clinical-Trial-in-a-Box tool to standardise data collection across decentralised platforms, with lessons learned applicable to Long COVID research.
From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials — Dulko et al., Journal of clinical and translational science
- dct
- rpm
2023
This protocol paper describes a decentralised HIV self-testing trial that enrolled 2093 Black and Hispanic men who have sex with men across 11 US states. The study incorporates laboratory analysis of participant-returned dried blood spot cards to verify self-reported HIV status, illustrating how patient-centric microsampling can be integrated into remote serology screening for underserved populations.
Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial — Dana et al., JMIR research protocols
- blood
- dried
- dbs
- self-collection
- dct
- serology
- sti
2023
Decentralised monitoring of people with type 2 diabetes using continuous glucose monitoring and a hybrid smartwatch was feasible, with high participant retention and successful collection of glucose, heart rate, activity, sleep and GPS data via a study app.
Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial — Ali et al., Journal of diabetes science and technology (paywalled)
- dct
- wearable
- rpm
- cgm
- digital-biomarker
- actigraphy
2023
The narrative review identified gaps in sustainability assessment within current DCT frameworks, noting that environmental impacts such as carbon footprint and disposal of sensors and investigational medicinal products are not comprehensively addressed, highlighting a need for more complete guidance.
Design and Execution of Sustainable Decentralized Clinical Trials — Singh et al., Clinical pharmacology and therapeutics (paywalled)
- dct
- standards
2023
Decentralised and site-less trial designs enable broader participation in rare cancer studies by mitigating travel burdens for underserved and rural populations.
Home-run trials for rare cancers: giving the right drug(s) to the right patients at the right time and in the right place — Adashek & Kurzrock, NPJ precision oncology
- oncology
- dct
2023
Lopinavir/ritonavir did not improve symptom resolution or reduce hospitalisation compared with placebo in non-hospitalised COVID-19 patients. The trial used remote daily surveys to monitor symptoms and outcomes, demonstrating the application of remote patient monitoring in a decentralised infectious-disease study.
Lopinavir/ritonavir for treatment of non-hospitalized patients with COVID-19: a randomized clinical trial — Kaizer et al., International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
- dct
2023
The authors propose a systems-thinking framework for evaluating decentralized clinical trial deployments, concluding that solutions must be customised to patient needs and trial requirements while identifying implementation enablers to address new systemic demands. This matters because it offers a structured approach for planning patient-centric decentralised studies, though it calls for further empirical validation.
Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment — Betcheva et al., Therapeutic innovation & regulatory science
- dct
2023
Remote smartphone cognitive testing using the ALLFTD Mobile App was feasible and acceptable for people with frontotemporal dementia and at-risk kindreds, supporting decentralised trials and improved access to research.
Feasibility and acceptability of remote smartphone cognitive testing in frontotemporal dementia research — Taylor et al., Alzheimer's & dementia
- dct
- rpm
- digital-biomarker
2022
A systematic review of 19,704 articles, analysing 45 trials and 117 documents, found wide heterogeneity in decentralised clinical trial designs. The authors caution that there is currently insufficient evidence to confirm which decentralised methods are most effective for trial recruitment, retention, or overall cost.
A systematic review of methods used to conduct decentralised clinical trials — Rogers et al., British Journal of Clinical Pharmacology (paywalled)
- dct
- validation
2022
An IQ Consortium position paper from sponsor scientists positioning patient-centric sampling as the enabling technology for decentralised trials, and stating that a bridging study against conventional sampling “has quickly been established as a regulatory expectation”.
Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality — Maass et al., Clinical and Translational Science
- blood
- dct
- standards
- self-collection
- validation
2022
The study demonstrates that fully remote clinical trials are feasible, as shown by a successful decentralised trial conducted during the pandemic. This supports the shift towards patient-centric, decentralised diagnostics by reducing the need for in-person visits.
Mental Health Clinical Research Innovations during the COVID-19 Pandemic: The Future Is Now — Ahern & Lenze, The Psychiatric clinics of North America
- dct
2022
The study found that acetylsalicylic acid recovered poorly from VAMS blood samples dried at room temperature, reaching only about 31% of the concentration measured in venous control samples, but humidity-controlled drying raised recovery above 85%. A household vacuum sealer achieved adequate humidity control at home, supporting the feasibility of decentralised, patient-centric blood sampling for acetylsalicylic acid monitoring.
Stability of acetylsalicylic acid in human blood collected using volumetric absorptive microsampling (VAMS) under various drying conditions — Moon et al., Translational and clinical pharmacology
- blood
- dried
- vams
- neoteryx-mitra
- validation
- tdm
- dct
2022
Teleconsent was perceived as more convenient than in-person consent with similar security and satisfaction, and achieved faster recruitment and fewer dropouts, supporting its use in decentralised trials.
Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent: A parallel-group pilot study among Danish citizens — Nyholm Gaarskjær et al., Contemporary clinical trials communications
- acceptability
- dct
2022
In a large decentralised hypertension trial of 21,104 adults, nearly half used their own home blood pressure monitors for remote monitoring, but 18.7% of identifiable devices lacked validation against standardised protocols despite costing substantially less than validated models. This reveals a critical gap in device quality for decentralised trials relying on patient-owned equipment.
Home blood pressure monitors owned by participants in a large decentralised clinical trial in hypertension: the Treatment In Morning versus Evening (TIME) study — Anbarasan et al., Journal of human hypertension
- dct
- rpm
2022
Citation network and regulatory analysis shows that Internet of Medical Things technologies, particularly telemedicine and remote monitoring across neurology and psychology, are increasingly positioned for adoption in decentralised clinical trials under evolving regulatory frameworks.
Application of Internet of Medical/Health Things to Decentralized Clinical Trials: Development Status and Regulatory Considerations — Sato et al., Frontiers in medicine
- dct
- standards
- rpm
2022
In simulations of a chronic weight-management trial, a mixed data-collection strategy where onsite visits for primary endpoints are supplemented by decentralised measurements at intermediate visits yielded unbiased estimates and valid inference at the key time points despite added variability or bias in the decentralised data. This suggests hybrid designs can cut patient burden while safeguarding statistical integrity for main trial outcomes.
Impact of Using A Mixed Data Collection Modality on Statistical Inferences in Decentralized Clinical Trials — Curtis & Qu, Therapeutic innovation & regulatory science
- dct
2022
An end-to-end remote digital protocol using the Current Health wearable and platform achieved rapid deployment and moderate adherence, capturing continuous pulse rate, respiratory rate, SpO2, skin temperature and step count alongside tablet-administered symptom surveys; vital signs remained within normal ranges and symptoms decreased over the 30-day period, demonstrating feasibility and clinical-grade signal quality for decentralised monitoring.
Deployment of an End-to-End Remote, Digitalized Clinical Study Protocol in COVID-19: Process Evaluation — Zahradka et al., JMIR formative research
- dct
- wearable
- rpm
- digital-biomarker
2022
In an Italian sample of 359 healthy adults the telephone ALS-CBS-PhV showed good reliability and diagnostic accuracy against established telephone cognitive tests (AUC 0.82-0.89) and was statistically equivalent to the in-person version, supporting its use for remote cognitive screening in motor neuron disease and in decentralised clinical trials.
ALS Cognitive Behavioral Screen-Phone Version (ALS-CBS™-PhV): norms, psychometrics, and diagnostics in an Italian population sample — Aiello et al., Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
- dct
- digital-biomarker
2022
The AFFECT study successfully recruited and characterised 48,467 participants with major depression, bipolar disorder, and controls through a fully remote design. This demonstrates the viability of large-scale virtual and decentralised cohorts for deep phenotyping and genomic analysis of psychiatric conditions.
Characterizing mood disorders in the AFFECT study: a large, longitudinal, and phenotypically rich genetic cohort in the US — Dalby et al., Translational psychiatry
- dct
- genotyping
2022
A fully remote home-testing model using dried blood spot self-collection and nasal swabs enrolled over 10,000 adults and achieved high retention, but demographic inequities emerged, indicating that remote trials can scale research and improve accessibility while requiring intensive participant support and robust technology to maintain engagement and data quality.
Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study — Naz-McLean et al., PloS one
- blood
- dried
- dbs
- self-collection
- dct
- serology
2022
The study found that decentralised data collection was reported in 68.9% of clinical trial protocols, especially in phase 3 trials, while other decentralised activities were less common. This highlights a growing but still limited adoption of decentralised methods in clinical research, with implications for designing more patient-centric trials.
Which decentralised trial activities are reported in clinical trial protocols of drug trials initiated in 2019-2020? A cross-sectional study in ClinicalTrials.gov — de Jong et al., BMJ open
- dct
2022
Surveyed oncologists and patients indicated that decentralized trials aim to reduce patient burden, increase enrollment and retention, and improve trial logistics via remote data collection, supporting a patient-centric shift in oncology drug development.
Role of decentralized clinical trials in cancer drug development: Results from a survey of oncologists and patients — de Las Heras et al., Digital health
- dct
2022
A six-month, fully decentralised trial in 100 atrial fibrillation patients using remote blood pressure and six-lead ECG sensors achieved 99% completion for device measurements and 91% for televisits, with oral anticoagulation adherence remaining stable at 96–97%. Rapid recruitment via social media (94 participants in 12 days) demonstrates that remote monitoring can sustain high engagement without clinic visits, supporting pandemic-proof trial designs.
Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP) — Sarraju et al., NPJ digital medicine
- dct
- wearable
- rpm
- digital-biomarker
2022
Most patients with motor neuron disease expressed a positive attitude towards remote monitoring and participating in decentralised clinical trials from home, with a majority finding the use of multiple digital devices acceptable for tracking respiratory function and muscle strength.
Patient perspectives on digital healthcare technology in care and clinical trials for motor neuron disease: an international survey — Helleman et al., Journal of neurology
- acceptability
- dct
- rpm
2022
Decentralised trial designs using digital tools such as wearables and electronic assessments can reduce patient burden and improve inclusion and data quality in rare disease studies by enabling measurements in real-world settings. This matters for decentralised diagnostics as it supports more accessible, patient-centric research with environmentally valid endpoints.
What role can decentralized trial designs play to improve rare disease studies? — Moore et al., Orphanet journal of rare diseases
- dct
- wearable
- digital-biomarker
2021
Remote SARS-CoV-2 antibody testing using self-collected dried blood spots proved feasible in decentralised trials, with 56% of consenting participants returning usable samples and 95% successfully completing self-collection despite pandemic logistical challenges. The agglutination-PCR method showed 83% concordance with ELISA, but mail delays and sample degradation complicated analysis and reduced data quality.
Feasibility of SARS-CoV-2 Antibody Testing in Remote Outpatient Trials — Lofgren et al., Open forum infectious diseases
- blood
- dried
- dbs
- self-collection
- dct
- serology
2021
Microsampling enables remote, contactless self-collection for Covid-19 serology and therapeutic drug monitoring, reducing infection risk and clinical staff burden while maintaining accuracy through validated assays. This supports decentralised clinical trials and population-level surveillance during a pandemic.
Microsampling: A role to play in Covid-19 diagnosis, surveillance, treatment and clinical trials — Rajadhyaksha & Londhe, Drug testing and analysis (paywalled)
- blood
- self-collection
- validation
- tdm
- dct
- serology
2021
The authors implemented a fully remote outpatient trial of hydroxychloroquine prophylaxis in 54 household COVID-19 contacts using self-collected saliva for SARS-CoV-2 RNA PCR testing and a smartphone-based six-lead ECG system for remote cardiac monitoring, with 42 participants completing the study and no serious treatment-related adverse events. The trial numbers were too small to assess prophylactic efficacy, but the experience demonstrates that decentralised enrolment, home diagnostic sampling and remote monitoring can be rapidly deployed in a community health system, while noting that lack of internet access excluded some potential participants.
The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic — Liu et al., Trials
- saliva
- self-collection
- dct
- serology
- rpm
- multimodal
2021
A hybrid trial in 99 toddlers achieved 97% adherence to electronic symptom diaries and obtained valid home-collected nasal swabs in 81% of acute respiratory infection episodes, demonstrating that decentralised procedures with parental self-sampling can reliably support respiratory virus diagnosis in paediatric vaccine trials.
Feasibility of a hybrid clinical trial for respiratory virus detection in toddlers during the influenza season — Muñoz-Ramírez et al., BMC medical research methodology
- self-collection
- pediatric
- dct
2021
In a decentralised design, HAE patients collected dried blood spot samples at home during attacks and at clinic visits, with high acceptability and sufficient sample volumes for LC-IM-QToF MS metabolomics, supporting the feasibility of patient-centric microsampling to discover disease activity biomarkers.
HAE patient self-sampling for biomarker establishment — Förster et al., Orphanet journal of rare diseases
- blood
- dried
- dbs
- self-collection
- acceptability
- dct
- biomarkers
2021
A surrogate-analyte LC-MS/MS method for cortisol in whole blood was validated, showing linearity from 0.5 to 500 ng/mL with acceptable accuracy and precision per regulatory guidance. Evaluation of patient samples demonstrated comparable cortisol concentrations in whole blood and plasma, indicating that whole blood sampling could support patient-centric, at-home collection in decentralised trials and clinical diagnostics.
A validated surrogate analyte LC-MS/MS assay for quantification of endogenous cortisol in human whole blood — Agrawal et al., Journal of pharmaceutical and biomedical analysis (paywalled)
- blood
- liquid
- validation
- hormones
- cortisol
- dct
2021
The study compared VAMS capillary finger prick samples with venous liquid and venous VAMS samples from 50 healthy volunteers for thiamine diphosphate measurement, finding 94 to 100 per cent of results within 20 per cent of their mean across all comparisons with no significant bias. VAMS microsamples also remained stable when sent through regular post without affecting results, supporting their use for decentralised thiamine status assessment in both developed and remote settings.
Volumetric absorptive microsampling (VAMS) as a reliable tool to assess thiamine status in dried blood microsamples: a comparative study — Verstraete & Stove, The American journal of clinical nutrition (paywalled)
- blood
- dried
- vams
- neoteryx-mitra
- validation
- venous-agreement
- dct
- biomarkers
2021
Smartphone photographs of atopic dermatitis lesions produced severity scores that correlated strongly with in-person clinical assessment (r=0.78) and were comparable to digital SLR camera images. The high inter-rater reliability among dermatologists supports remote photo-based scoring for decentralised trials and telehealth, reducing patient burden.
Remote Rating of Atopic Dermatitis Severity Using Photo-Based Assessments: Proof-of-Concept and Reliability Evaluation — Ali et al., JMIR formative research
- dct
- rpm
- digital-biomarker
2021
Capillary blood collected by fingerstick showed near-perfect correlation with venous samples for HbA1c (R² = 0.993), with 96.7% of paired results differing by no more than 0.2%. Most participants found the kit easy to use at home, indicating potential for decentralised diabetes monitoring when in-person visits are impractical.
Comparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies — Nathan et al., PloS one
- blood
- liquid
- capillary
- validation
- venous-agreement
- acceptability
- dct
2021
Daily home-based saliva collection proved feasible for six to eight weeks in people with dementia and their caregivers, with a quarter showing decreases in both morning and evening cortisol, suggesting stress reduction. Caregivers displayed a significant flattening of the morning to evening cortisol slope and dyads showed correlated evening cortisol trends, demonstrating that self-sampling can objectively monitor stress in decentralised studies of vulnerable populations.
The use of saliva steroids (cortisol and DHEA-s) as biomarkers of changing stress levels in people with dementia and their caregivers: A pilot study — Theorell et al., Science progress
- saliva
- self-collection
- hormones
- cortisol
- dct
2020
A Danish virtual feasibility study of 55 adults with atopic dermatitis found that remote recruitment and self-collection of DNA samples by mail, combined with weekly smartphone tasks, achieved 96% retention and over 90% task adherence, over a short eight-week study with self-reported outcomes.
High adherence and low dropout rate in a virtual clinical study of atopic dermatitis through weekly reward-based personalized genetic lifestyle reports — Ali et al., PLOS ONE
- dct
- acceptability
- self-collection
- genotyping
2020
Self-collected saliva samples provided adequate DNA for genotyping in preterm birth research, though questionnaire data on birth details had limited concordance with prospective records, indicating that while DNA sampling is feasible via post, phenotyping requires more reliable data collection methods for genetic studies.
Postal recruitment for genetic studies of preterm birth: A feasibility study — Keag et al., Wellcome open research
- dct
- dna-genotek-oragene
- self-collection
- liquid
- saliva
- genotyping
2020
Protein abundances measured by SomaScan were comparable between capillary samples collected with the TAP device and venous samples, and selected ELISA assays showed strong correlation, supporting the use of the TAP device for quantitative protein biomarker analysis in decentralised trials.
Evaluation of a novel blood microsampling device for clinical trial sample collection and protein biomarker analysis — Xing et al., Bioanalysis (paywalled)
- dct
- venous-agreement
- blood
- capillary
- yourbio
- biomarkers
2020
In a randomised trial of 260 women undergoing natural cycle frozen embryo transfer, home-based ovulation monitoring using urine LH tests provided greater feelings of empowerment and treatment discretion compared with hospital monitoring, despite similar increases in anxiety and sadness across both pathways.
Home- or hospital-based monitoring to time frozen embryo transfer in the natural cycle? Patient-reported outcomes and experiences from the Antarctica-2 randomised controlled trial — Zaat et al., Human reproduction
- urine
- self-collection
- acceptability
- fertility
- hormones
- dct
2020
AstraZeneca's two case studies showed that reduced pharmacokinetic sampling schedules and composite plasma and dried-blood profiles in patient-centric trials maintained outcomes while lowering burden. This validates decentralised therapeutic drug monitoring and haematocrit modelling, but success demands organisational collaboration and accepting that no single device fits all patients.
Giving patients choices: AstraZeneca's evolving approach to patient-centric sampling — Bailey et al., Bioanalysis (paywalled)
- blood
- dried
- dct
- haematocrit
2020
This workshop report provides recommendations on blood sampling sites, bridging study design, and statistical methods for correlation to support the adoption of microsampling in patient-centric drug development. It emphasises the critical need for away-from-clinic sampling techniques to maintain patient safety during the COVID-19 pandemic.
Land O'Lakes Workshop on Microsampling: Enabling Broader Adoption — Wickremsinhe et al., The AAPS journal
- blood
- capillary
- venous-agreement
- acceptability
- dct
- standards
2020
Women using a home-based, app-connected urine ovulation test achieved pregnancy in 25.4% of first cycles versus 14.7% for those not using tests (p<0.001), with a cumulative two-cycle rate of 40.8% versus 30.0% (p=0.026). This shows that decentralised hormone self-sampling can significantly improve conception rates while reducing intercourse frequency through better cycle timing.
Increased Likelihood of Pregnancy Using an App-Connected Ovulation Test System: A Randomized Controlled Trial — Johnson et al., Journal of women's health
- urine
- self-collection
- fertility
- hormones
- dct
2020
In adult kidney transplant patients, adding DBS home sampling to usual care did not reduce outpatient visits or per-visit costs versus usual care alone, though most patients were willing to use DBS if it cut hospital attendances; logistical optimisation of mailing and timely analysis is required to realise travel and cost benefits.
Effects, costs and implementation of monitoring kidney transplant patients' tacrolimus levels with dried blood spot sampling: A randomized controlled hybrid implementation trial — Veenhof et al., British journal of clinical pharmacology
- blood
- dried
- dbs
- self-collection
- acceptability
- tdm
- immunosuppressants
- dct
- economics
2020
The review highlights that volumetric absorptive microsampling enables easy, minimally invasive home sampling with room temperature storage and fixed volume accuracy, making it a viable alternative for clinical trials and therapeutic drug monitoring during the COVID-19 pandemic.
Volumetric Absorptive Microsampling as a Sampling Alternative in Clinical Trials and Therapeutic Drug Monitoring During the COVID-19 Pandemic: A Review — Harahap et al., Drug design, development and therapy
- blood
- dried
- vams
- neoteryx-mitra
- validation
- tdm
- dct
- haematocrit
2019
In a fixed-sequence two-period Phase I study of 16 healthy volunteers taking sitagliptin, dried blood spot samples collected at home and digital adherence data captured via an electronic pill bottle were feasible and acceptable to participants. This supports patient-centric microsampling and remote monitoring for decentralised clinical trials, though the authors noted areas needing improvement.
Leveraging Digital Health Technologies and Outpatient Sampling in Clinical Drug Development: A Phase I Exploratory Study — Dockendorf et al., Clinical pharmacology and therapeutics
- blood
- dried
- dbs
- self-collection
- acceptability
- dct
2017
A review of 151 clinical trials found that only 56% met their recruitment targets, with a median retention rate of 89%. Investigators should avoid over-optimistic projections, suggesting a clear role for decentralised, patient-centric sampling to help trials reach their targets.
Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme — Walters et al., BMJ Open
- dct
- economics
- acceptability
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