We recently asked our 1,200+ LinkedIn followers (you can join the community here!) if they were planning on including decentralized elements in their trials even post-Covid. An overwhelming majority (92%) said YES.
If I had doubts before, it’s clear to me now: virtual and hybrid clinical trials are here to stay. More than just a mitigation strategy, decentralizing clinical trials is an opportunity to include new, more diverse patient populations and support them regardless of what’s going on in the world.
Covid-19 was just the catalyst of that shift, showing both CROs and Sponsors the importance of being agile. Though the industry is infamously slow to change, and though paused trials are resuming (stay tuned for more on that!), introducing virtual elements is still very much on everyone’s mind. So, what are the benefits and challenges to decentralizing trials in 2021?
Patient engagement is a huge one! Depending on the elements you introduce, you can improve patient recruitment, adherence and retention.
Let me give you an example. A few years back, when we were working in digital patient recruitment, we were faced with an unexpected challenge: to support patients with Myasthenia gravis, the Sponsor had included transportation to and from the site, yet patients still were hesitant to visit the site and many turned down participation for this reason.
It turned out, since most of them were dealing with terrible fatigue, even an hour’s ride to the site was exhausting. They wanted to spend the little energy they had on something that would bring them more joy than a car ride.
Now, had the treatment and testing been delivered to them, they would’ve been more eager to participate.
This is just one example of many but the bottom line is this – decentralization works to address not only patients’ needs but their objections as well.
“I don’t want to travel to the site even if someone else is driving – I’m too tired even for this”, the patients say. “You don’t have to. We’ll deliver the treatment to your doorstep and monitor you from your home”, you answer.
Responding to customers’ objections is a big deal in the marketing world and you can borrow it to improve patient recruitment and retention.
Another benefit of introducing virtual elements, of course, is mitigating unpredictable risks. No one could’ve foreseen the Covid-19 pandemic and the global lockdowns that followed and no one knows when or what the next crisis might be.
The thing about this pandemic is that it showed us how suddenly the things we take for granted could change and how important contingency planning really is. But, going from a traditional to a fully virtual clinical trial doesn’t happen overnight.
Experience is needed to switch successfully between the two models. In that sense, introducing decentralized modalities before it’s absolutely critical to do so is building know-how. Having done it before, you can – in a moment of crisis – navigate the landscape more easily and keep operations going in any circumstance.
Virtual clinical trials are not without their challenges. Let’s talk about the patients first.
In part 3 of the webinar “How research sites can win with decentralized trials”, Edye Edens, Raymond Nomizu, Daniel Perez and our Maya Zlatanova talk about the hidden pitfalls of eConsent. With eConsent, how can you ensure the patient is truly informed when making a decision? How to account for the cultural, not just the language barriers?
The truth is, no solution is perfect. While virtual modalities can help you reach more patients, digitalizing important steps of the process can also pose ethical dilemmas that are better handled face-to-face.
An in-person interaction, for example, can give you hints as to whether the patient is confused, hesitant or actually not feeling that well. Digitalization can support but not fully replace the human connection so critical in medicine.
This is not a red light but rather something to think about when considering to what extent you’re going to incorporate technology. I really, really recommend watching part 3 of the webinar – such important questions are raised!
Another challenge to virtual clinical trials is finding the right partners. From investigators who already have relevant experience to ePRO providers to home healthcare services – knowing who to work with is so important, yet so hard to figure out.
In fact, we were thinking about how to make this decision easier on CROs and Sponsors right in the beginning of the Covid pandemic. Out of that desire to help, The Ultimate Guide to Virtual Clinical Trial Vendors was born. It effortlessly navigates you between 130 providers of technologies and services like eConsent, ePRO, home healthcare, health ride, telemedicine and digital patient recruitment.
If you need additional help, you can check out our post on how to choose the right vendors for your virtual or hybrid trial.
And, if you’re currently working on a trial or a proposal and you urgently need insights, you may benefit from our one-off pilot program.
Raw data is not everything – especially with virtual trials. Take a look at a case study we did recently: only thanks to the real-life insights of country advisors was the CRO able to gauge the technical literacy of the patients they were targeting. And when we’re talking about virtual trials this information is super important.
In fact, that’s another challenge you’d need to consider – how well does your target patient population handle technology, not only if they’re technically literate. My parents are technically literate, it doesn’t mean they like interacting with technology.
Data, however, won’t tell you that. When it comes to patients, there are certain questions that only real-life experience can answer. If you’re having such questions, reach out to us, we’d be happy to support you even if it’s that one particular thing you need.