ObvioHealth and 1nHealth have announced they are joining forces on an initiative designed to streamline the transition from traditional studies to hybrid and decentralized clinical research. The project will focus on supporting trials that may be faltering due to a number of reasons, including protocol design, recruitment strategy, technology, and site teams.
Outsourcing-Pharma checked in with Ivan Jarry, CEO of ObvioHealth, to learn more about the challenges site-based studies are facing and how they can clear the obstacles to DCT adoption and continue running.
OSP: Why do firms that can run traditional trials encounter such problems when trying to run a decentralized study?
IJ: There are nuances to decentralized clinical trials that can cause hiccups along the way, and many traditional firms don’t have the experience to foresee potential issues in the study design. Legacy CROs and sponsors often have blind spots because the traditional way of conducting trials is so ingrained in their ways of working.
For example, when conducting a trial that uses a remote monitoring device, we found that women in warmer climates did not want to wear a heart rate monitor – due to its visibility when wearing lighter clothing. Most traditional CROs and sponsors have no way of knowing this because they don’t have the experience. ObvioHealth has been conducting fully virtual and hybrid studies since 2017 – long before the pandemic – so we have more experience and a better understanding of what works and what doesn’t.
OSP: What are common protocol design and recruitment challenges that companies unfamiliar with decentralized trials come up against?
IJ: DCTs may be easier for patients, but convenience doesn’t always translate to better compliance. It’s important for DCTs to engage with the patients. In a traditional trial, this engagement occurs via the site team, but in virtual trials, this type of interaction with the patient is sometimes forgotten.
That’s why ObvioHealth created our virtual site team. This team engages with patients virtually – through phone, text, or live chat. The virtual site teams are available at all times. The norm tends to be more, rather than less communication.
Our past four trials had 100 percent of the 367 participants chatting with ObvioHealth’s team. Interestingly, the bulk of these chats was not linked to the need for tech support. More often, patients have questions about the study product, health conditions, and both broad or very specific study-related concerns. This communication with patients is ongoing, as opposed to the staccato, infrequent interaction that occurs in traditional trials. Our virtual site team is a conduit to better patient insights that we then build into our future study designs.
Another protocol feature that is often overlooked is patient training. Patients need to be trained on how to input their data to avoid inaccurate reporting. For example, if you’re asking a patient to record how often he/she takes a drink of water, patients need to be trained on the definition of a drink of water. Is it a small sip or a big gulp? Sponsors and CROs often think this training cannot be done virtually, but this is a misconception. We successfully train patients virtually in most of our trials.
From a recruitment perspective, we understand the patient flow that starts with an anonymous internet user’s exposure to an ad –to ab interested “lead” to an identified/prescreened patient to an enrolled and onboarded participant. Each of these steps has a different requirement and associated bottleneck that must be thoughtfully navigated.
We also understand how to speak with different target cohorts on the internet. Generation Z uses the internet differently than do Baby Boomers so it’s important to understand their use habits and to tweak the messaging to the target.
OSP: How will ObvioHealth and 1nHealth approach solving these challenges? What are the advantages – for the sponsors and CROs you work with – of your two companies working together on this?
IJ: We’ve actually been working as partners since before COVID. This partnership has enabled us to confront and address much of the friction in the recruitment onboarding and data collection process. It is so important to capture participant prospects while the interest is hot. This requires a seamless transition from recruitment to enrollment, and if time is wasted, the patient could lose interest and fall out of the funnel.