Over the past year and a half, the decentralized 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 as a way to increase access to trials – making it possible for more (and more diverse) patients to enroll in studies.
That’s important for two main reasons.
First, 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 commitment of time and money in order to attend multiple in-person visits. That patient was fortunate to have those resources to spare.
For other patients, enrolling in a clinical trial is simply 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. Just imagine having to choose 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 simply 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 reflects 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 need to 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, reliable results.
While the DCT model may not be a panacea, it can solve for some of the most obvious obstacles. It makes it easier to engage patients – whether through virtual visits or geofencing to alert for possible adverse events. More important, 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.