Thanks to their convenience and personal privacy, at-home sampling and test kits first gained a foothold in the over-the-counter market with the introduction of pregnancy tests in the 1970s, followed in the 1990s by products for detecting sexually transmitted diseases. Since then, the product category has expanded widely to include self-administered swabs for DNA and genealogical testing, as well as tests for fertility, organ function, and other key health factors.

In the wake of the COVID-19 pandemic, home sampling kits that allow people to draw their own blood easily with a finger-prick, which permitted clinical research to continue remotely during lockdowns and social distancing rules, are now enabling researchers to safely and cost effectively expand their available pools of trial participants — pandemic or no.

The combination of rising consumer interest in healthcare with at-home sampling technology that enables greater accessibility to participate in adaptive and decentralized clinical trials represents a significant opportunity for clinical leaders. In addition to making participation more equitable for small and large cohorts, this improved accessibility translates into more rapid participant recruitment, reduced rates of drop-out and cost-effective medium and long term participant follow-up. 

During its first ever clinical trial which was reported in 2020, Australia-based Drop Bio Health asked the project’s healthy volunteers to collect and send in 15 samples of their own blood over a six-month period. The company discovered that participants not only increased their skill at collecting finger-prick blood samples during the trial. Volunteers also grew more proficient at answering questions about their lifestyle behavior, providing even more useful data for researchers in the process.

All of the company’s training for research participants now occurs through online video and over 98% of returned samples arrive back to Drop Bio Health’s labs in good condition — with the sample volumes needed for successful trials, according to the company’s co-founder & CEO, Phil Hayes-St Clair. “A core element of our IP is understanding how biomarkers change in transit,” he says. “We include smart data loggers in each sample collection kit that track a number of environmental factors from the moment the kit is dispatched to the time it arrives back in our lab.”

Drop Bio Health’s in-transit data loggers are used to analyze blood samples and accurately determine blood biomarker concentrations, based on when they were collected and the environmental conditions undergone while they’re in transit, for up to eight days. (In practice, Drop Bio Health’s average sample return time is only 1.5 days.) “We are proud of pioneering this critical approach that unlocks the ability to deliver true at-home clinical research and healthcare,” says Hayes-St Clair.

‍What started as a personal health services provider focused on inflammation and women’s reproductive health has since become a leading innovator in the field of clinical trial support services. Drop Bio Health has advanced sampling processes and technologies considerably, innovating the technology for at-home testing to reduce recruiting costs and dropout rates of participants, thanks to its far greater convenience as compared to regular visits to a clinical site. The company employs a staff of scientists, healthcare professionals, communicators and software engineers to produce its test kits and ensure successful training and results from trial participants.

“Logistics are critical to at-home healthcare, and we integrate directly with express post services to ensure at-home smart sample collection kits are delivered on time and importantly that collected samples are returned via express post in a matter of days,” says Hayes-St Clair. “Our approach to at-home logistics increases convenience which drives adoption and continued participation.”

New self-administered blood sampling tools such as Drop Bio Health’s help reduce workload on health care providers, improve telemedicine outcomes and deliver better personalized patient care. Home testing for clinical trials reduces the stress on participants with busy schedules or who are not well enough to leave home. It also eliminates the need for time-consuming site visits, leading to better enrolment and retention of participants and significantly reducing the number who drop out of trials.

To maintain clinical trial participants’ privacy, Drop Bio Health secures and separately manages personally identifiable digital health data associated with collected blood samples while they’re in transit or at rest. “We have a deep belief at Drop Bio Health that we are custodians of people’s most intimate data and as a result it’s our responsibility to keep that knowledge safe and secure,” St Clair says. “We invest heavily and continuously in our people, processes and technical infrastructure to ensure ethics approvals for clinical studies and to make sure those standards also apply to insurers, health providers, and employers.”

Not only does Drop Bio Health ensure safe and efficient collection of blood samples from clinical trial participants, but the company also plans soon to help researchers identify which drug targets are best to pursue. “Identifying which are the most promising candidates to pursue is the most expensive part of therapeutics development,” says Hayes-St Clair. “Shortly we’ll be able to help pharma partners to query our data to inform those target decisions,” he says.

The advantages of remote trial protocols are substantial and represent part of a broader trend towards the decentralization of trials and clinical research. Overall, self-administered at-home sampling technology drives down costs for trials, with fewer and smaller clinical sites required, making it easier and less costly for researchers to scale up studies across larger geographical regions and bigger patient pools. As clinicians increasingly embrace virtual tools and remote testing technology, smart home sampling kits such as Drop Bio Health’s are certain to continue playing an important role in how clinical research methods evolve.

Author

Cagla Ertugrul

Cagla Ertugru holds a Master’s degree in Industrial Engineering from the Technical University of Berlin. She is a tech enthusiast with a passion for the latest in tech and med-tech.

Declaration of interests

I have read and understood the BMJ Group policy on declaration of interests and declare the following interests: none.