Decentralized Clinical Trials in Early Drug Development—A Framework Proposal DOI Creative Commons
D. Silva, Blessie Elizabeth Nelson, Jordi Rodón

et al.

Journal of Immunotherapy and Precision Oncology, Journal Year: 2024, Volume and Issue: 7(3), P. 190 - 200

Published: May 7, 2024

The COVID-19 pandemic has led to a rethinking of clinical trial design maintain research activity, with regulatory changes allowing for the wider implementation and development decentralized models. Evidence feasibility benefits associated remote comes mainly from observational studies or phase 2 3 trials, in which is easier better-established safety profile. Early drug slow expensive process accrual are key aspects success. Applying model 1 trials could improve patient by removing geographic barriers, improving population diversity, strengthening evidence rare tumors, reducing patients' financial logistical burdens. However, monitoring, data quality, shipment, administration investigational product challenges its implementation. Based on published we propose an exploratory framework solutions enable conceptualization trials.

Language: Английский

Painless Capillary Blood Collection: A Rapid Evaluation of the Onflow Device DOI Creative Commons
Lara Noble, Caitlin Dixon,

Alison Moran

et al.

Diagnostics, Journal Year: 2023, Volume and Issue: 13(10), P. 1754 - 1754

Published: May 16, 2023

Blood-based diagnostics are critical for many medical decisions, but mostly rely on venepuncture, which can be inconvenient and painful. The Onflow Serum Gel (Loop Medical SA, Vaud, Lausanne, Switzerland) is a novel blood collection device that utilises needle-free technology to collect capillary blood. In this pilot study, 100 healthy participants were enrolled provided two collected specimens one venous specimen. Five chemistry analytes (AST, ALT, LDH, potassium, creatinine) haemolysis measured per specimen, laboratory analyte results compared. was found more acceptable than venepuncture with lower pain ratings, 96.5% of would use the method again. All phlebotomists (100%) intuitive user-friendly, ~1 mL successfully from 99% in <12 min (mean: 6 min, 40 s) 91% first attempt. ALT AST showed no difference performance, while creatinine generated negative bias (-5.6 µmol/L), increased variability noted potassium (3.6%CV) LDH (6.7%CV), although none clinically relevant. These differences may due 35% having "mild" haemolysis. promising alternative should now evaluated expected abnormal chemistries as an option self-collection.

Language: Английский

Citations

13
­­Evaluating blood sampling strategies within the SIREN study: the experience from a large cohort of healthcare workers in the UK DOI Creative Commons
Nipunadi Hettiarachchi,

Debbie Blick,

Tom Coleman

et al.

Research Square (Research Square), Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 19, 2025

Abstract Background Delivering research studies that require a large number of samples to monitor specific populations is complex, often resulting in high costs and intricate logistics. We aim describe the processes for blood sample collection management evaluate alternative sampling methods within cohort healthcare workers UK (the SIREN study). Methods conducted process evaluation. First, we described across different study periods from June 2020 March 2024 how these evolved over time. Secondly, compared sampling: venous phlebotomy (hospital-based) vs. capillary (at-home). Results The main challenges with stemmed scale use decentralised 135 hospital sites during COVID-19 pandemic. adapted our as progressed, overcoming most challenges. When comparing hospital-based at-home sampling, overall, return rates taken at home were higher than site- based (80% vs 71%, respectively). At-home took less time be returned UKHSA Laboratory testing (median 2 days; interquartile (IQ) 2-3) 6 IQ 3-8). However, more likely considered void (4%) when tested (0%). Cost was almost 3-times (£34.05 £11.50, respectively), however larger volumes obtained via (8 ml 600 µl whole blood). Conclusions Sample are complex. Our results support an effective cheaper strategy therefore should method future research. Trial registration number: ISRCTN11041050 - date 12/01/2021.

Language: Английский

Citations

0
NEW TRENDS IN BIOANALYSIS SAMPLING AND PRETREATMENT: HOW MODERN MICROSAMPLING IS REVOLUTIONISING THE FIELD DOI Creative Commons
Michele Protti, Elisa Milandri,

Roberta Di Lecce

et al.

Advances in Sample Preparation, Journal Year: 2025, Volume and Issue: unknown, P. 100161 - 100161

Published: Feb. 1, 2025

Language: Английский

Citations

0
Feasibility, acceptability, and safety of a novel device for self-collecting capillary blood samples in clinical trials in the context of the pandemic and beyond DOI Creative Commons
Harika Dasari, Anna Smyrnova, Jing Leng

et al.

PLoS ONE, Journal Year: 2024, Volume and Issue: 19(5), P. e0304155 - e0304155

Published: May 29, 2024

Background Home blood self-collection devices can enable remote monitoring, but their implementation requires validation. Our objectives were to explore (i) the impact of sampling sites and topical analgesia on capillary volume pain perception (ii) safety, acceptability, failure among adults children using Tasso-SST device. Methods We conducted a two-phase study. The investigational phase consisted two on-site cross-sectional studies in healthy adult participants (≥ 12 years) (1–17 with accompanying parent. Adults received 4 samplings, where puncture randomized factorial design, venipuncture; (and one parent) had sampling. co-primary outcomes pain. was multicentre trials choosing visits; volume, collection failure, adverse events, satisfaction documented. Results In , 90 9 7 parents enrolled; 15 2 preschoolers participated . study, device collected median (25%, 75%) 450 (250, 550) μl no significant difference between site, analgesia, its interaction. Using reduced by 0.61 (95% CI: 0.97, 0.24; P <0.01) points 11-point scale; reduction varied lower back showing most decrease. Overall, combining all phases, 425 500) μl, rate 4.4%; minor effects reported 8.9% participants, willing use again. Conclusion Capillary self-collection, yielding slightly less than 500 proves be safe relatively painless method for children, high low rates. site do not affect could reduce

Language: Английский

Citations

2
Comparison of capillary blood self-collection using the Tasso-SST device with venous phlebotomy for anti-SARS-CoV-2 antibody measurement DOI Creative Commons
Elise King, Haley E Garrett, Haley Abernathy

et al.

Journal of Immunological Methods, Journal Year: 2023, Volume and Issue: 520, P. 113523 - 113523

Published: July 8, 2023

Language: Английский

Citations

4
Minimally Invasive Blood Collection for an Mpox Serosurvey among People Experiencing Homelessness DOI Creative Commons
Caroline J. Waddell,

Gerald J. Pellegrini,

Neela Persad

et al.

The Journal of Applied Laboratory Medicine, Journal Year: 2024, Volume and Issue: 9(5), P. 1014 - 1019

Published: June 6, 2024

People experiencing homelessness (PEH) are underrepresented in public health and clinical research. Study methods that can improve participation by this group needed.

Language: Английский

Citations

1
Comparison of Capillary Blood Self-Collection using the Tasso-SST Device with Venous Phlebotomy for anti-SARS-CoV-2 Antibody Measurement DOI Open Access
Elise King, Haley E Garrett, Haley Abernathy

et al.

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2023, Volume and Issue: unknown

Published: March 16, 2023

Measuring seroprevalence over time is a valuable epidemiological tool for improving our understanding of COVID-19 immunity. Due to the large number collections required population surveillance as well concerns about potential infection risk collectors, self-collection approaches are being increasingly pursued. To advance this methodology, we collected paired venous and capillary blood samples by routine phlebotomy Tasso-SST device respectively from 26 participants measured total immunoglobulin (Ig) IgG antibodies SARS-CoV-2 receptor binding domain (RBD) enzyme-linked immunosorbent assay (ELISA) on both specimens. Qualitatively, no discrepancies were noted in binary results between Tasso venipuncture-derived plasma. Furthermore, vaccinated participants, correlation Ig specific antibody quantitative levels was high (Total Ig: ρ = 0.72, 95% CI (0.39- 0.90); IgG: 0.85, (0.54, 0.96)). Our support use at-home collection devices testing.

Language: Английский

Citations

1
Decentralized Clinical Trials in Early Drug Development—A Framework Proposal DOI Creative Commons
D. Silva, Blessie Elizabeth Nelson, Jordi Rodón

et al.

Journal of Immunotherapy and Precision Oncology, Journal Year: 2024, Volume and Issue: 7(3), P. 190 - 200

Published: May 7, 2024

The COVID-19 pandemic has led to a rethinking of clinical trial design maintain research activity, with regulatory changes allowing for the wider implementation and development decentralized models. Evidence feasibility benefits associated remote comes mainly from observational studies or phase 2 3 trials, in which is easier better-established safety profile. Early drug slow expensive process accrual are key aspects success. Applying model 1 trials could improve patient by removing geographic barriers, improving population diversity, strengthening evidence rare tumors, reducing patients' financial logistical burdens. However, monitoring, data quality, shipment, administration investigational product challenges its implementation. Based on published we propose an exploratory framework solutions enable conceptualization trials.

Language: Английский

Citations

0