Incorporating Site-less Clinical Trials Into Drug Development: A Framework for Action

Hirsch, Irl B.; Martinez, Joe; Dorsey, E. Ray; Finken, Gerald; Fleming, Alexander; Gropp, Chris; Home, Philip; Kaufer, Daniel I.; Papapetropoulos, Spyros

doi:10.1016/j.clinthera.2017.03.018

Cited by 44 publications

(44 citation statements)

References 18 publications

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“…Novel trial designs may provide more appropriate data, while also improving patient access; for example, pragmatic trials which are designed to show patient-relevant effectiveness of an intervention in broad patient groups, reflecting the population and management strategies in real-world practice [71]. Additionally, the use of technology, ranging from simple telephone contact, through web and smartphone tools and medical-grade wearable sensors to collect real-world data in home settings has the potential to reduce the costs, inconvenience, and labour associated with regular clinic attendance required during trials [72]. Such tactics may prove particularly beneficial for improving patient inclusion and robustness of data in rare diseases, such as MPN, where specialists are thinly spread and geographic proximity to trial centres is an issue.…”

Section: Regional Variability In Access To Clinical Trialsmentioning

confidence: 99%

The Myeloproliferative Neoplasm Landscape: A Patient’s Eye View

Petruk¹,

Mathias²

2020

Adv Ther

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Section: Regional Variability In Access To Clinical Trialsmentioning

confidence: 99%

The Myeloproliferative Neoplasm Landscape: A Patient’s Eye View

Petruk¹,

Mathias²

2020

Adv Ther

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“…In addition, other biologic data could easily be obtained from a second VAMS device (another 10 μL of blood), including DNA samples for genomic sequencing of the host or blood-borne pathogens. Such methods are likely to be increasingly used in clinical trials in remote and rural areas, as well as newer "siteless" clinical trials [39,40].…”

mentioning

confidence: 99%

Application of volumetric absorptive microsampling (VAMS) to measure multidimensional anti-influenza IgG antibodies by the mPlex-Flu assay

Wang

Wiltse

et al. 2019

J. Clin. Trans. Sci.

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Introduction: Recently, volumetric absorptive microsampling (VAMS) has been used for accurate sampling of a fixed peripheral blood volume (10 µL) on a volumetric swab, and long-term sample storage. The mPlex-Flu assay is a novel, high-throughput assay that simultaneously measures the concentration of antibodies against the hemagglutinin (HA) proteins from multiple influenza virus strains with ≤5 µL of serum. Here we describe combining these two methods to measure multidimensional anti-influenza IgG activity in whole blood samples collected by a finger stick and VAMS, with correction for serum volume based on simultaneous hemoglobin measurement. Methods: We compared capillary blood samples obtained from a finger stick using a VAMS device with serum samples collected by traditional phlebotomy from 20 subjects, with the influenza antibody profiles measured by the mPlex-Flu assay. Results: We found that results with the two sampling methods were highly correlated within subjects and across all influenza strains (mean R2 = 0.9470). Adjustment for serum volume, based on hemaglobin measurement, was used to estimate serum volume of samples and improved the accuracy. IgG measurements were stable over 3 weeks when VAMS samples were stored at room temperature or transported using a variety of shipping methods. Additionally, when volunteers performed finger-stick VAMS at-home by themselves, the comparison results of anti-HA antibody concentrations were highly consistent with sampling performed by study personnel on-site (R2 = 0.9496). Conclusions: This novel approach can provide a simple, accurate, and low-cost means for monitoring the IgG anti-influenza HA antibody responses in large population studies and clinical trials.

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“…Study drug adherence can be monitored using a combination of telemedicine visits to talk with patients and preaddressed shipping containers provided to participants to send unused study drug back to the study site for drug accountability. 40 In some cases, intravenous infusions could be done remotely by means of home infusion companies or at local infusion centers. Careful coordination of all these activities is required to preserve the safety of the participants and comply with federal and local regulations.…”

Section: Study Drug Supply Considerationsmentioning

confidence: 99%

“…People with ALS typically have limited mobility, or fatigue easily, or both, and travel to an ALS Center can be challenging even for those Abbreviations: ALS, amyotrophic lateral sclerosis; ALSAQ- 40 who live nearby. Some patients may not have the financial resources or the necessary equipment or supplies (accessible vans, power chairs, necessary personnel) for safe travel to a major ALS center.…”

Section: Introductionmentioning

confidence: 99%

Optimizing telemedicine to facilitate amyotrophic lateral sclerosis clinical trials

et al. 2020

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Amyotrophic lateral sclerosis (ALS) has the largest drug pipeline among neuromuscular diseases, with over 160 companies actively involved in ALS research. There is a growing need to recruit trial participants, but ALS patients often have limited mobility and most ALS trials are conducted in a small number of major centers. These factors effectively limit patient participation, particularly for those in rural areas. The current coronavirus disease 2019 (COVID-19) pandemic has necessitated the more widespread use of telemedicine technology for clinical care, and has prompted consideration of its increased use for clinical trials. In this opinion piece, we describe the current state of telemedicine for recruitment, consenting, and screening of participants for clinical trials. We also summarize the available data on remote administration of outcome measures. Current challenges include validation of outcome measures for remote assessment, as well as technological, regulatory, and licensure barriers. K E Y W O R D S

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Incorporating Site-less Clinical Trials Into Drug Development: A Framework for Action

Cited by 44 publications

References 18 publications

The Myeloproliferative Neoplasm Landscape: A Patient’s Eye View

The Myeloproliferative Neoplasm Landscape: A Patient’s Eye View

Application of volumetric absorptive microsampling (VAMS) to measure multidimensional anti-influenza IgG antibodies by the mPlex-Flu assay

Optimizing telemedicine to facilitate amyotrophic lateral sclerosis clinical trials

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