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

и другие.

Journal of Immunotherapy and Precision Oncology, Год журнала: 2024, Номер 7(3), С. 190 - 200

Опубликована: Май 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.

Язык: Английский

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

Alison Moran

и другие.

Diagnostics, Год журнала: 2023, Номер 13(10), С. 1754 - 1754

Опубликована: Май 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.

Язык: Английский

Процитировано

15
­­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

и другие.

Research Square (Research Square), Год журнала: 2025, Номер unknown

Опубликована: Фев. 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.

Язык: Английский

Процитировано

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

и другие.

Advances in Sample Preparation, Год журнала: 2025, Номер unknown, С. 100161 - 100161

Опубликована: Фев. 1, 2025

Язык: Английский

Процитировано

0
Determining the Efficacy, Feasibility, and Impact of Storage Conditions on At-Home Blood Collection Kits for Proteomic Studies DOI Creative Commons

Caroline Scranton,

Xiaoxiao Sun,

Denazir Atizol Rodriguez

и другие.

medRxiv (Cold Spring Harbor Laboratory), Год журнала: 2025, Номер unknown

Опубликована: Май 16, 2025

At-home blood collection kits have the potential to greatly increase efficiency of for diagnostic or research purposes by reducing cost and burden on participants, researchers, physicians eliminating need a phlebotomist, specialized equipment, on-site processing. These shown be effective studying specific metabolites proteins, but analyses targeting entire proteome, their effectiveness is unknown. For this study, data human serum proteome was compared when capillary-collected with Tasso+ device (Tasso Inc.) versus gold-standard venous samples drawn trained phlebotomist. Analyses were conducted using SomaScan 7K assay (SomaLogic Inc.), which assesses levels nearly 7,600 proteins. Additionally, duplicate also subjected variety pre-processing storage temperatures times mimic effects shipping from participants baseline samples. Minimal differences seen between results capillary all participants. Delays in processing greater than 48 hours led large changes detected protein throughout while lower holding (refrigeration at > 4°C) decreased amount change proteome. Overall, it determined that processed immediately, gives similar blood, minimizing time ( < hrs) temperature can minimize collected at-home assay.

Язык: Английский

Процитировано

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

и другие.

PLoS ONE, Год журнала: 2024, Номер 19(5), С. e0304155 - e0304155

Опубликована: Май 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

Язык: Английский

Процитировано

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

и другие.

Journal of Immunological Methods, Год журнала: 2023, Номер 520, С. 113523 - 113523

Опубликована: Июль 8, 2023

Язык: Английский

Процитировано

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

Gerald J. Pellegrini,

Neela Persad

и другие.

The Journal of Applied Laboratory Medicine, Год журнала: 2024, Номер 9(5), С. 1014 - 1019

Опубликована: Июнь 6, 2024

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

Язык: Английский

Процитировано

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

и другие.

medRxiv (Cold Spring Harbor Laboratory), Год журнала: 2023, Номер unknown

Опубликована: Март 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.

Язык: Английский

Процитировано

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

и другие.

Journal of Immunotherapy and Precision Oncology, Год журнала: 2024, Номер 7(3), С. 190 - 200

Опубликована: Май 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.

Язык: Английский

Процитировано

0