In recent years, there have been a lot of conversations about how clinical researchers design and execute clinical trials. Are we still designing trials that rely solely on the participants’ ability to visit study sites? Are we designing decentralized trials – sometimes called site-less trials, or virtual trials that rely on technology for remote data collection and patient engagement? Or are we designing studies that are a hybrid of those two approaches, using technology to reduce the need for some in-person visits but still preserving the value of activities that can be done at sites? And which approach is best?
From our perspective, what we should really be talking about is how to design and run clinical trials that work better for all patients. To do that, we need to address the things that they want most from their clinical trial participation.
Patients Want Hope
When a patient joins a clinical trial, it often means they have exhausted other treatment options. They are hoping that some new therapy will save, extend, or improve their quality of life. This is why it is so important that when designing new clinical studies, we work to make research as accessible as possible for as many eligible patients as possible. For many diseases and conditions, recruiting based entirely on geographic distance from trial sites can make study participation impossible for huge groups of people. But, by employing at least some technology-enabled approaches, we can open the door to research opportunities for those living further away from traditional study centers, those with mobility challenges, the immunosuppressed, and those without the financial means for travel to sites.
Solutions like eConsent and ePRO/eCOA allow patients and their caregivers to participate in studies from home, reducing the need for frequent clinical visits which can be a heavy burden – both in terms of time and money – for families. Site teams and sponsors can use platforms like TrialKit to track all study data, whether collected at sites or remotely, from a central platform. This allows them to stay on top of any study, no matter how widely dispersed the participants, with a great deal of confidence. Using these technologies, we can make study participation realistic as a care option for more patients.
Patients Want Safety
Safety means different things to different people. Depending on the disease condition, some patients may feel safer by making clinical visits. They may feel more secure, for example, receiving infusions or cardiac testing at a hospital surrounded by clinicians. Others, particularly those with conditions that impair their immune systems, may fear contracting a potentially deadly infectious disease during a clinic visit. These patients can be made to feel safer when remote technologies allow them to fulfill study responsibilities from home. Either way, doing the work to understand what a given study population’s attitudes and preferences are can help us to select the right tools to provide patients with the safest experiences.
Patients Want to Feel Connected
Remote technologies can be a great help. Certainly, some patients look at the ability to participate as a reason to get involved in study. Still, it is critical that we don’t take decentralization to the extreme and leave patients and their caregivers on an island. Patients still need to feel connected to their study teams – they want to know the people and build trust. This engagement can make or break studies. Participants who feel unsupported are more likely to drop out of studies, a tragedy for those looking at a clinical trial as their last chance. For sites and sponsors, this likely means more costs and time needed to be thrown into enrollment, delaying the potential approval of therapies that can help people. Luckily, even if a study utilizes multiple decentralized approaches, technology tools can also be used to open channels between patients and their care teams. Platforms like TrialKit Engage make it simple for study teams to have face time with participants via virtual visits, from one easy-to-use app. Participants can reach out when they need help or have questions so that, even if they are hundreds of miles from the site team, they can talk with and see a friendly face. Preserving this connection between patients and clinicians keeps patients engaged and studies on schedule.
By thinking through how to deliver better patient experiences, we can bring hope to more people looking at research as a care option. Using technological advancements in the way Crucial Data Solutions has done with TrialKit, we can build studies that work better for study participants while producing high quality study data.
For more information on building and delivering patient-centered studies, or to arrange a demo of TrialKit, visit https://www.crucialdatasolutions.com/contact-us/.