The rise of home diagnostics in clinical trials

The field of home diagnostics has seen significant innovation and advancement in the past few decades – and in the wake of the COVID-19 pandemic, the growing use of home testing has allowed important clinical research to continue remotely.

The advantages of embracing remote trial protocols are substantial, suggesting that the adaptations made in response to COVID-19 are part of a broader move towards decentralizing trials and clinical research. As clinicians increasingly embrace virtual tools and remote testing, home diagnostics will play an important role in how clinical research progresses.

In this article, we discuss the advantages and disadvantages of home diagnostics, and the implications of its rise for the future of clinical trials.

The growth of home diagnostics

Home diagnostics has a varied history; initially developed to offer patients sensitive testing in the privacy of their own homes, the field has expanded greatly since the first at-home pregnancy tests became available in the 1970s ^[1]. From intimate procedures such as testing for sexually transmitted diseases – at-home HIV tests have been available since 1996 ^[2] – commercial home diagnostics has expanded to include DNA and genealogical testing, as well as starting to cover the wellness market by offering consumers proactive testing for fertility, organ function, and more.

In fact, by the late 2010s the home diagnostics market was fast-growing, with one 2017 report showing the market expected to reach USD 6.53 billion by 2025 ^[3]. But at-home testing is not limited to commercial products – the applications for clinical research are many.

Home diagnostic tools provide clinicians with the ability to gather important data points remotely. Health data that can be collected via home testing includes blood pressure, pulmonary testing, dermatological diagnosis ^[4], and neurological testing. In addition, highly customized home collection kits allow patients to collect and submit their own biological samples directly for laboratory testing, removing the need for clinicians to manage the preparation, packaging, and shipping of samples.

As clinical research adopts remote testing and patient monitoring as standard protocol, the clinical trial landscape will need to adjust to help see trials and research to successful outcomes.

The advantages of home diagnostics

For clinicians and health care practitioners (HCPs) alike, home diagnostics offers a host of benefits:

Easing strain on healthcare systems – as at-home testing and monitoring becomes more affordable, faster, and more accurate, this can ease pressure on HCPs managing heavy workloads – particularly when it comes to routine testing and patient monitoring.
Improving and increasing telemedicine – many medical appointments are now conducted over phone or video chat, and home diagnostics lets HCPs request tests remotely, reducing the need for patients to visit clinics and hospitals.
Personalizing patient care – home diagnostics improves clinicians’ ability to offer faster and better-targeted medical care and gives patients a more accessible and personalized approach to managing their own individual healthcare.
Improved patient experience in clinical trials – home testing can eliminate the need for time-consuming site visits, reducing the burden on patients who may be either too busy to miss work for appointments, or too unwell to leave home for travel.
Better patient enrollment and retention in clinical trials – making the trial process easier on participants increases patient enrollment and retention, reducing the commercial impact associated with patients dropping out of trials.
Cost reduction in clinical trials – with fewer and smaller clinical sites required, it becomes easier and less costly for trials to scale up studies for larger regions and bigger patient pools.

Logistical challenges for clinical researchers

The logistics of implementing at-home testing involve a number of key considerations for clinicians and trial service providers alike, including:

Getting the right kits to the right patients at the right time – at-home testing necessitates careful logistics management, particularly for large-scale studies, that clinicians may lack the expertise to undertake. Working with experienced providers capable of managing quick turnarounds and accelerated timelines will help clinicians deal with these emerging logistical challenges.
Participant coaching – patients need to be guided in how to administer tests and study drugs at home. Clinicians may need to provide in-person or video training, and clear at-home kit and testing design is needed to make the process as simple as possible for trial participants.
Tracking and tracing of clinical samples – to preserve the integrity of clinical materials, trial sample kits must be properly labeled and assembled, with clear instructions for use and automated tracking to mitigate the risk of human error.
Inventory tracking – in order to manage the supply and distribution of testing and drug administration kits, inventory must be carefully monitored. Use of an external system, such as PASSPORT™ from Avantor Clinical Services, can greatly reduce the logistical burden that at-home testing places on clinicians.
Preservation of sample integrity through the shipping process – kits must be properly assembled to make sure samples are securely packaged for their return, including the option of refrigerated shipping to keep samples at optimal temperature during the journey from home to lab.
Data and privacy concerns – to guarantee patient privacy and data security, labeling and indexing must be carefully managed throughout the shipment, collection, and storage of all patient samples and data, to accurately record the source of such samples, where appropriate, or to anonymize or blind samples in other cases.

What home diagnostics means for clinical trials

The field of home diagnostics has the potential to ease the transition from traditional on-site clinical research models into a remote approach that takes advantage of improved health technologies. Combined with the increased use of mHealth tools such as wearables and smartphone apps, and the adoption of telemedicine, home diagnostics will play a vital role in enabling trial protocols to shift towards a decentralized approach.

With significant clinical advantages to be gained by using home diagnostics – particularly as COVID-19 necessitates a remote approach to clinical research – it’s important that clinical trial managers and clinical service providers work together to manage the fast-changing needs of the trial landscape. At Avantor Clinical Services, we have been able to move quickly to help identify the resources needed for at-home testing and expedite the provision of kits for collecting at-home patient samples in a COVID-19-related study. These kinds of interventions will be crucial in adapting home testing to the meet the changing needs of clinical trials in future.

Summary

As the field of clinical research responds to changing circumstances in light of global health concerns, home diagnostics is one tool among many that will facilitate remote clinical research, but it is an essential one. Decreasing or eliminating the need for on-site visits will improve patient enrollment and retention and reduce the cost of research studies – enabling trials to progress quickly and efficiently, and ultimately get important treatments to market faster.

This article has been produced by Avantor Clinical Services as part of our ongoing commitment to creating a better world through the delivery of mission-critical products and services.

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References

Erin Blakemore. This Is What the First Home Pregnancy Test Looked Like. June 2015. https://www.smithsonianmag.com/smart-news/what-first-home-pregnancy-test-looked-180955478/. Accessed May 2020.
Mobolaji Ibitoye, Timothy Frasca, Rebecca Giguere, and Alex Carballo-Diéguez. Home Testing Past, Present and Future: Lessons Learned and Implications for HIV Home Tests (A Review). May 2014. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3988264/. Accessed June 2020.
Global Home Diagnostics Market is Expected to Reach USD 6.53 Billion by 2025: Fior Markets. August 2019. https://www.globenewswire.com/news-release/2019/08/28/1907833/0/en/Global-Home-Diagnostics-Market-is-Expected-To-Reach-USD-6-53-Billion-by-2025-Fior-Markets.html. Accessed May 2020.
The Medical Futurist. Digital Skin Care: Top 8 Dermatology Apps. June 2019. https://medicalfuturist.com/digital-skin-care-top-8-dermatology-apps/. Accessed June 2020.