Most of our blogs focus on interesting things we hear from sponsors, new company developments, or interesting challenges we encounter as we partner with sponsors. This month, however, we want to take a look at it from the patient perspective. The changes of the past year have resulted in a shift in perception on the part of potential participants about their willingness to participate in DCTs.
One of our team members recently received an email proposing they participate in a clinical trial for a mobile sensor device. The email was filled with statements about how it was completely remote based, no travel, all online. Instead of being something a bit new and perhaps risky, a trial being offered as a DCT is now a selling point for the project … perhaps a necessary one from the perspective of the desired participants. Because something like 80% of ongoing clinical trials, most of which were “traditional,” were interrupted or even stopped due to the COVID-19 pandemic (reference 1), this shift in perception is not unexpected. DCTs are now much more well known in the industry and this has trickled down into the patient population. Further, as we’ve become more accustomed to staying home and away from other people “outside our bubble” whenever possible, trials that offer home-based services with minimum on-site interactions appear very favorable, compared to traditional trials. What we hear from patients is that we need to maintain high-touch care, and the high-tech approach is the way to accomplish this.
But let’s back up a bit. Let’s start with where we were when the pandemic was just beginning. Research done in March 2020 (reference 2) showed that more than half of sites expected a negative impact on enrollment and nearly half believed, at the time, that there would be a negative impact on study retention. This was a clarion call that things were going to need to change. Now, a year into the pandemic, we are seeing a much broader acceptance of trials incorporating DCT elements. This comes from both sponsors seeking more resilient trial designs – which also have the potential to speed enrollment – and from the participating patients themselves, who have shown a natural preference for interacting in ways that are both more convenient and less risky. Even sites are increasingly on board and have new tools at their disposal, enabling trial continuity. By last fall, at least 42% of investigator sites reported themselves as being ready to incorporate elements of DCTs into their trials (reference 2), a number which has surely grown since then.
For our part, we have dedicated our organization to developing and promoting patient-centric designs that make the trials not just easier on the sponsors, but that provide a better experience for patients and sites. This transition has been occurring gradually for years, but the pandemic generated a sea change moment in our beliefs, absolutely forcing us to confront the limitations of the old model, creating a willingness about adopting high-tech and high-touch solutions in trials. It’s not optional now – and it’s also not going to be universally adopted for every trial. Sites, sponsors and patients all want these options when it makes sense to make trials easier.
We are striving to make “the new normal” anything but normal. Instead, we have embarked on a cycle of what we think will be a continuous re-invention of what the trial of the future can be. We look forward to making this journey with you.
- Dorn, A. V. (2020). COVID-19 and readjusting clinical trials. The Lancet, 396(10250), 523-524. doi:10.1016/s0140-6736(20)31787-6
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