Decentralised clinical trials (DCTs) have existed for a reasonably long time. However, the pandemic accelerated their mainstream adoption with sudden restrictions concerning travel and physical contact.
As we are past the worst of the crisis, the momentum created is here to stay. After all, increased DCT adoption has unfolded a path of several efficiency and patient benefits, a significant one being the amplification of health equity.
What are decentralised clinical trials?
Decentralised clinical trials, virtual clinical trials, or siteless clinical trials basically refer to contactless and digital trials. In decentralised modes of clinical studies, the subject recruiting, medicine delivery and administration, and data gathering on the trial's outcomes occur without face-to-face contact between the trial participants and the research investigator.
How did COVID-19 introduce momentum for decentralised trial adoption?
Between January to April 2020, there was a 50 per cent drop in the number of monthly trials in response to the dangers of the public health emergency. Consequently, trial sponsors responded with a technological push to ensure the continuity of clinical studies.
Virtual trials were immediately optimised to ensure compliance, including remote consent and videoconferencing for assessments, phlebotomy at home, etc. With that, DCT adoption multiplied immediately, unfolding varied benefits.
How does it enhance equity and equality in healthcare?
In traditional clinical trials, the cohort under study is usually linked geographically to the central point for practical reasons. After all, investigators must calibrate the study group across several parameters to ensure accurate results. Ensuring this consistency across a spread-out cohort costs extensive resources, which are finite.
Data confirms this reasoning. A McKinsey study found that over 70 per cent of people lived more than two hours away from a trial site. As a result, this limited choosing a widely spaced-out cohort for conducting clinical studies. The outcome was that members of minority communities, people of colour, different ethnicities, and diverse socioeconomic groups were commonly left underrepresented as participants and clinical trial investigators. Consequently, studies could gather only limited clinical evidence on how drugs are assimilated by various bodies, depending on their physiological, gender, or ethnicity-related differences. Thus, analyses were inevitably biased by setting.
With decentralisation, many of these traditional challenges are left behind. This is introducing more significant equity in healthcare research:
- Doors have opened to include more volunteers and investigators for studies with no travel requirements.
- As diversity in trial investigators is now possible, there is a natural spillover toward improving the diversity of clinical trial participants who feel more comfortable participating. This includes people of all genders, ethnicity, race, and socioeconomic background.
- Moreover, as decentralisation leverages digital media for targeting volunteers, there's also enhanced cohort diversity as more people are willing to participate and follow through due to ease.
- Academic researchers can also now become principal investigators without additional administrative burden or cost.
All these are improving outcomes in equity and inclusivity and will advance healthcare further in the coming years.
The near future looks hybrid
As of now, decentralised trials cannot eliminate traditional site visits despite all their benefits towards equity and research outcomes. Studies sometimes require physical visits regarding specific complex procedures and specialised assessments, such as screenings and magnetic resonance imaging. However, hybrid trial designs are certainly a potent way to boost equity to a large extent with decentralisation.
Kinzal Jalan is an experienced B2B content marketer with demonstrated expertise in Health, SaaS and Technology.