Home-based clinical trials, also known as decentralized or virtual clinical trials, allow participants to participate from the comfort of their own homes. Clinical trials are vital for the advancement of medical science. Before medicine is shipped out to the wider world, it is important to test it thoroughly to determine its efficacy and any side effects.
The rise of home-based trials during the COVID-19 pandemic
At the height of the COVID-19 pandemic, between 2020 and 2022, it was vitally important to do two things; 1) develop a vaccine, and 2) stop the spread.
Unfortunately, these two things, in some ways, required contradictory things. While there was still no vaccine for COVID-19, the best way to prevent the spread was to self-isolate or quarantine when someone close became infected. This is a strategy to help prevent the spread of disease mankind has practised since ancient times.
However, in order to develop a vaccine, drugs needed to be tested, and clinical trials needed to be carried out. If such research were to take place at a clinical trials site, it could have easily facilitated the spread of COVID-19, despite ostensibly working to prevent it.
To this end, home-based trials between individual medical experts and patients were more effective. In a time when people were encouraged to avoid large groups as much as possible, clinical trial sites may have caused more problems than they solved.
Problems with traditional clinical trials
According to a recent study by GlobalData, a mere 10% of clinical trials result in an approved drug. One argument for this is that only a limited number of trial sites are effective, with 20% of trial locations doing 80% of the work, according to James Eamma, executive director of therapeutic strategy, oncology at Worldwide Clinical Trials. So it seems that selecting the right trial sites to work with is crucial for the success of a trial.
However, are sites being set up for failure? Suzy Montanye, Site Relationship Manager at Endo Pharmaceuticals, shared valuable insight into the often-overlooked perspective of clinical trial sites presenting a case study in which she spent 25 hours screening a single patient. Facing challenges such as explaining protocols, justifying the large number of data points requested by sponsors—often unclear in the protocol—and troubleshooting issues with faulty equipment or ambiguous sponsor instructions during screening. She also had to deliver the disappointing news to the patient that they did not meet the inclusion criteria after their own investment of time and hope in the process. Montanye described this as a typical day for site staff, raising the question: are we underestimating the time and effort sites dedicate to trials.
With this in mind, it is worth asking what can be done to make clinical trials more effective. One solution is to take the test site out of clinical trials; sending nurses directly to participants at their own homes. This reduces the burden on sites and site staff and removes the risk to sponsors of picking the wrong site.
Home-based trial benefits for patients
Beyond COVID-19, in-person trials can be useful for patients more generally. Many illnesses worldwide disproportionately affect the elderly or the disabled. Similarly, for such groups, attending clinical trials at trial sites may prove difficult.
Indeed, research by Trials Journal found that disabled people have often been precluded from clinical trials without sufficient justification, and concluded that such exclusion “exacerbates disparities in healthcare and diminishes the benefits for excluded populations.” This same study reported that although 82% of staff were aware that the assessments and site visits could be burdensome for disabled people, only 42% of disabled people had been asked about the need for support/adjustment when participating in clinical trials.
According to a study published in NPJ Digital Medicine, only 5% of eligible patients take part in clinical research. The study also highlighted that women, older adults, individuals from historically marginalized communities, and those with comorbidities are especially underrepresented. Expanding access to remote and home-based clinical trials offers a promising solution to help address these disparities.
In this regard, at-home trials will likely continue to prove to be a better solution. When people cannot attend clinical trials themselves, it makes sense to bring the trials to the participant. This has the added benefit of aiding some of the most vulnerable people in society.
Home-based trials building trust
For the most part, people don’t understand medical science, and what people don’t understand, they find harder to trust. Needles are scary. Pills are scary. Putting them into our body without knowing what’s in them is terrifying.
Given this is the case, in-person clinical trials are a natural counter-balance to this distrust. A study by Dr. Richard Baron in Wolters Kluwer found that key drivers of mistrust between patients and doctors were “they spend too little time with me,” and “they do not know me/do not listen to me.”
Miscommunication, overall, is the main driver of mistrust, and it’s far easier to have poor communication when patients are in large groups and doctors have to generalise. It makes medicine seem foreign and impersonal to patients. Therefore, one-to-one sessions allowed for by in-home trials appear to offer a solution to build more trust with patients.
In summary
The shift towards home-based clinical trials, accelerated by the COVID-19 pandemic, highlights the potential for these trials to improve the efficiency and inclusivity of clinical research. By allowing participants to engage from the comfort of their own homes, these trials address many challenges faced by traditional site-based trials, such as patient accessibility, site selection issues, and burdens on staff. Home-based trials can better serve underrepresented groups, such as the elderly, disabled, and marginalised communities, offering a more personalised and patient-centric approach.
As the healthcare landscape continues to evolve, home-based trials are playing an increasing role in making clinical research more effective, inclusive, and trustworthy, benefiting both the medical community and the patients they serve.
Want to learn how we can support your home-based trial?
Our mobilehealth services facilitate remarkable experiences within the comfort of patients’ own homes. Decentralised and hybrid clinical trials provide greater choice for patients to participate in studies on their terms. This has a direct impact on recruitment and retention rates and significantly improves clinical outcomes.
From the initial design of patient-first protocols and equipment logistics to the final stages of visit planning, scheduling, and management our services encompass every aspect of the home-based clinical trial journey. Through our partner talent and recruitment agency, seacolehealth, we recruit expert healthcare practitioners trained to the highest standard in conducting decentralised trial visits.
