Published - Tue, 24 Jan 2023
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:
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:
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.
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. To learn more, contact us today
Tue, 24 Jan 2023
Tue, 24 Jan 2023
Tue, 24 Jan 2023