Will patient-centric sampling become the norm for clinical trials after COVID-19?

James, Christopher; Barfield, Matthew; Maass, Katie F.; Patel, Shefali; Anderson, Melanie

doi:10.1038/s41591-020-01144-1

Cited by 25 publications

(26 citation statements)

References 7 publications

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“…During the early months of the pandemic, sponsors were not able to collect critical biological specimens for safety, pharmacokinetics and pharmacodynamics. In many cases, sponsors implemented alternative sampling for trials already in flight [ 31 ]. Pharmaceutical companies implemented remote nursing or mobile phlebotomy visits to conduct safety assessments and collect critical biological specimens.…”

Section: Patient Centric Sampling During the Pandemicmentioning

confidence: 99%

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How the Covid-19 Pandemic is Changing Clinical Trial Conduct and Driving Innovation in Bioanalysis

Anderson¹

2021

Bioanalysis

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Thousands of clinical trials all over the world were stopped, disrupted or delayed while countries grappled to contain the pandemic and research resources were redeployed. The long-term effects of the turbulence caused by the pandemic have yet to be fully understood, but it should already be clear that the increased focus on participant needs and on the logistical challenges of current models are not likely to fade away quickly. This disruption is opening doors for rethinking traditional approaches to clinical trial conduct – including decentralizing site visits, introducing new methods of sample collection, rethinking matrix selection, reducing sample volumes and collaborating on device development. These approaches reduce participant burden while improving critical trial data.

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Section: Patient Centric Sampling During the Pandemicmentioning

confidence: 99%

“…Patient centric sampling with remote collection options enabled by new collection devices and matrices with optimized assays can provide critical data in clinical research. The ability to collect samples outside a clinical site visit has the potential to transform clinical trials and healthcare more broadly [ 31 , 35 , 36 ].…”

Section: Remote Collectionmentioning

confidence: 99%

How the Covid-19 Pandemic is Changing Clinical Trial Conduct and Driving Innovation in Bioanalysis

Anderson¹

2021

Bioanalysis

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“…However, medical laboratory serological tests require venous blood drawn by healthcare professionals, and rapid self-tests using capillary blood currently do not fulfill the precision requirements 13 , 14 . Indeed, an attractive strategy would combine home- or self-sampling with precise laboratory analysis 15 , especially when measures need to be taken to limit exposure and infections. Dried blood spots (DBS) is a well-established method to screen neonates for in-borne disease and has also been used to detect antibodies against viruses 16 .…”

Section: Introductionmentioning

confidence: 99%

Multianalyte serology in home-sampled blood enables an unbiased assessment of the immune response against SARS-CoV-2

et al. 2021

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Serological testing is essential to curb the consequences of the COVID-19 pandemic. However, most assays are still limited to single analytes and samples collected within healthcare. Thus, we establish a multianalyte and multiplexed approach to reliably profile IgG and IgM levels against several versions of SARS-CoV-2 proteins (S, RBD, N) in home-sampled dried blood spots (DBS). We analyse DBS collected during spring of 2020 from 878 random and undiagnosed individuals from the population in Stockholm, Sweden, and use classification approaches to estimate an accumulated seroprevalence of 12.5% (95% CI: 10.3%–14.7%). This includes 5.4% of the samples being IgG+IgM+ against several SARS-CoV-2 proteins, as well as 2.1% being IgG−IgM+ and 5.0% being IgG+IgM− for the virus’ S protein. Subjects classified as IgG+ for several SARS-CoV-2 proteins report influenza-like symptoms more frequently than those being IgG+ for only the S protein (OR = 6.1; p < 0.001). Among all seropositive cases, 30% are asymptomatic. Our strategy enables an accurate individual-level and multiplexed assessment of antibodies in home-sampled blood, assisting our understanding about the undiagnosed seroprevalence and diversity of the immune response against the coronavirus.

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“…However, blood sample collection remains a challenging procedure to perform remotely as venipuncture is resource-intensive, physically uncomfortable, and inflexible in regard to collection time and location. 1, 2 Remote self-administered blood collection, on the other hand, offers many practical advantages, including 1) expanded lab testing for rural and remote medicine applications (i.e., telemedicine), 2) convenience for clinical research studies as well as the ability to recruit participants that are not able to come to the clinic (due to work schedules, caregiver responsibilities, mobility challenges, etc. ), 3) the ability to capture acute and transient biomarker fluxes (e.g., immediately following an acute exposure, an asthma attack, or a flare in an autoimmune disease), and 4) opportunities to conduct longitudinal research studies that require frequent sample collections from the same individual over a short time course (e.g., daily blood collections); to-date these applications have been limited due to the logistical challenges associated with in-person venipuncture.…”

Section: Introductionmentioning

confidence: 99%

homeRNA: A self-sampling kit for the collection of peripheral blood and stabilization of RNA

Haack

Lim

Kennedy

et al. 2021

Preprint

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Gene expression analysis (e.g., targeted small gene panels, transcriptomics) from whole blood can elucidate mechanisms of immune function and aid in the discovery of biomarkers. Conventional in-clinic venipuncture offers only a small snapshot of our broad immune landscape as immune responses may occur outside of the time and location parameters available for conventional venipuncture. A self-operated method that enables flexible sampling of liquid whole blood coupled with an immediate stabilization of cellular RNA is instrumental in facilitating capture and preservation of acute or transient immune fluxes. To this end, we developed homeRNA: a kit that allows for self-collection of peripheral blood (~0.5 mL) and immediate stabilization of cellular RNA, using the Tasso-SST™ blood collection device paired with a specially designed stabilizer tube containing RNAlater™. To assess the usability and feasibility of homeRNA for self-collection and stabilization of whole blood RNA, we conducted a pilot study (n = 41 participants) where we sent homeRNA to participants aged 21-69, located across 10 US states (94% successful blood collections, n = 51). Among participants who successfully collected blood, 91% reported no or minimal pain/discomfort using the kit (n = 35), and 77% reported easy or somewhat easy stabilization protocol. Total RNA yield from the stabilized samples ranged between 0.24 µg and 5.99 µg (mean = 1.65 µg), while RNA Integrity Number (RIN) values were above 7.0 (mean = 7.9), indicating limited RNA degradation. Results from this study demonstrate the self-collection and RNA stabilization of whole blood with homeRNA by participants themselves, in their own home.

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Will patient-centric sampling become the norm for clinical trials after COVID-19?

Cited by 25 publications

References 7 publications

How the Covid-19 Pandemic is Changing Clinical Trial Conduct and Driving Innovation in Bioanalysis

How the Covid-19 Pandemic is Changing Clinical Trial Conduct and Driving Innovation in Bioanalysis

Multianalyte serology in home-sampled blood enables an unbiased assessment of the immune response against SARS-CoV-2

homeRNA: A self-sampling kit for the collection of peripheral blood and stabilization of RNA

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