Over the past year and a half, the decentralized clinical trial (DCT) model has helped many studies stay on track amid the disruption of the COVID-19 pandemic. In many ways, the pandemic has served as a real-world case study demonstrating this model’s advantages. And yet, the pandemic was not the genesis of decentralized trials. Decentralized trials emerged to increase trial access, making it possible for more (and more diverse) patients to enroll in studies.
That’s important for two main reasons.
Firstly, not all patients have sufficient margin in their lives to sign on for a clinical trial. In an earlier post, I shared the story of a patient who enrolled in a trial – and made major sacrifices to participate – in hopes of saving her life. That decision required significant time and money to attend multiple in-person visits. That patient was fortunate to have those resources to spare.
Additionally, for other patients, enrolling in a clinical trial is cost-prohibitive. They may be unable to take the needed time off work. They may not have cash in the bank to cover lost earnings and travel expenses. Even if trial visits are local, some patients may not have readily available childcare or transportation. Imagine choosing between participating in a potentially life-saving trial or keeping your children safe and fed.
Are these patients less deserving of a chance to benefit from a trial? Of course not!
The system hasn’t been designed for diversity, inclusion, and equity.
And that isn’t just bad for patients; it’s bad for trials, too.
That brings me to the second reason: When a trial only enrolls patients who can afford to participate, that trial’s findings provide a similarly limited evaluation of treatment safety and efficacy. It’s perhaps the worst-kept secret in the industry – that trial data seldom reflect a treatment’s performance for a full complement of patients.
It’s time for clinical trials to engage patients who reflect the diversity of our society. We must find ways to recruit and retain people across all levels of educational attainment and income, living environments, and vocations. Only then can we help more people and produce more accurate and reliable results.
While the DCT model may not be a panacea, it can solve some of the most obvious obstacles. It makes it easier to engage patients through virtual visits or geofencing to alert them of possible adverse events. More importantly, it reduces the burden on patients by potentially lowering the volume of in-person appointments and automating much of the process for collecting patient-reported outcomes.
Datacubed Health’s technology makes it possible to design your trials for greater engagement, convenience, and flexibility. So you can more readily recruit a diverse, inclusive patient population – while reducing the burden on everyone in your trial.
To learn more about the Datacubed difference, watch this five-minute demo detailing why we’re different.