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.
18 papers labelled “standards”, newest first.
2026
Guidance on capillary-to-plasma conversion: method- and analyte-specific clinical validation with paired capillary–venous samples before reporting plasma-equivalent results.
To Convert or Not to Convert? Official IATDMCT Guideline on Converting Capillary-Blood Microsampling Concentrations to Plasma Concentrations — Boffel et al., Therapeutic Drug Monitoring (paywalled)
- venous-agreement
- blood
- tdm
- standards
- dried
- capillary
- validation
2026
This UK consensus opinion outlines how clinical laboratories can validate self-collected capillary blood sampling against venous reference standards to achieve accreditation and facilitate the shift towards community-based patient care.
UK recommendations for the validation and adoption of capillary blood testing within the routine clinical laboratory: Consensus opinion from the LabMed patient-centred testing and sampling (PaCTS) group — Woolley et al., Annals of clinical biochemistry (paywalled)
- venous-agreement
- blood
- standards
- self-collection
- capillary
- liquid
- validation
2026
This review establishes that microsampling across blood, saliva, urine and stool matrices offers validated workflows and regulatory recognition for human biomonitoring comparable to conventional methods. It finds that these decentralised approaches enhance participant acceptability and enable screening in remote or low-resource settings.
Integrating Microsampling in Human Biomonitoring: Methodologies, Regulatory Frameworks, and Case Study Insights — Rajamani & Poongavanam, Critical reviews in analytical chemistry (paywalled)
- wearable
- acceptability
- multimodal
- sweat
- blood
- dbs
- standards
- dried
- serology
- colorectal
- pediatric
- stool
- urine
- validation
- saliva
- biomarkers
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 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
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
The paper highlights that while self-collection microsampling devices for blood and other matrices are advancing decentralised testing, standardisation of sample collection and integration into clinical workflows is critical for reliable results. This matters because it identifies key hurdles that must be overcome for patient-centric sampling to be widely adopted in healthcare.
Standardization of Microsampling Technologies for Accurate Sensing and Reliable Diagnostics — Mora & Mace, ACS sensors (paywalled)
- blood
- standards
- self-collection
- haematocrit
- validation
- saliva
2025
A 2025 review maps 28 microsampling devices, from dried spots and volumetric absorptive tips to upper-arm liquid capillary collectors, and names what a laboratory must control before their results are used: the haematocrit effect in non-volumetric dried samples, interstitial fluid from finger milking, volume, haemolysis and transport stability. Regulators on both sides of the Atlantic ask for the same two things, a device the patient can use safely and a sample fit for the test.
Patient centric blood sampling and analysis for diagnostics and laboratory medicine — Spooner et al., Bioanalysis
- blood
- standards
- self-collection
- haematocrit
- dried
- capillary
- liquid
- validation
2025
This study introduces a statistical approach based on an information criterion to assess agreement between two measurement methods, evaluating six models simultaneously to provide an objective decision rule. The method is demonstrated using real data sets from patient-centric microsampling, offering a robust tool for method validation and regulatory compliance.
An Information Criterion Approach for Assessing Agreement When Comparing Two Methods of Measurement — Tan et al., Statistics in medicine (paywalled)
- validation
- standards
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
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
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
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
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
2020
A multi-institution workshop made the case for a characterised whole-stool reference material so microbiome measurements can be standardised across labs, addressing the absence of defined faecal inputs.
Toward a human whole-stool reference material for metabolomic and metagenomic gut-microbiome measurements — Mandal et al., Metabolomics
- standardised-input
- metabolome
- standards
- microbiome
- metagenomics
- stool
- validation
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
2019
The consensus guideline defining the analytical- and clinical-validation requirements for dried-blood TDM: the standardisation reference for implementing a dried assay clinically.
Official IATDMCT Guideline: Development and Validation of Dried Blood Spot-Based Methods for Therapeutic Drug Monitoring — Capiau et al., Therapeutic Drug Monitoring (paywalled)
- blood
- dbs
- tdm
- standards
- haematocrit
- dried
- validation
2016
A review of clinical DBS across TDM, metabolic monitoring and trials, arguing that analytical and clinical validation must be obligatory before clinical use.
Clinical feasibility of dried blood spots: analytics, validation, and applications — Enderle, Foerster & Burhenne, J. Pharmaceutical and Biomedical Analysis (paywalled)
- blood
- dbs
- tdm
- standards
- dried
- validation
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