The clinical research industry has seen a great deal of creativity and ingenuity in the past year, with COVID-19 fueling the need for innovation. Ivan Jarry, CEO of virtual research organization (VRO) ObvioHealth, spoke with Outsourcing-Pharma about why it is vital for the industry to continue moving forward, collaborating with other firms, and keeping the patient at the center.
OSP: From your perspective as a VRO, how dramatically has the decentralized trial (DCT) landscape shifted since COVID-19 changed everything?
IJ: The attitudes within pharma companies have certainly changed - they seem to have moved from whether to conduct DCTs to how to do so. Prior to the pandemic, we encountered many pharmaceutical executives that were hesitant to conduct virtual trials.
Now, we have pharma companies coming to us interested in implementing virtual elements into their trials. According to recent data, more than 55% of active ongoing clinical trials have transitioned to remote and virtual execution models since early 2020. Of course, at ObvioHealth, all of our trials are partially or entirely remote, so we benefit from this evolution.
The industry has shifted on the CRO side, as well. Many of the world’s largest CROs have become our partners for DCT but also sometimes our competitors; the latter is more in principle than in practice, as what we do is quite different from the way a traditional CRO approaches DCT.
Most CROs have rushed to implement virtual trial technologies to capitalize on the increased demand, but these technologies are being retrofitted onto older software and technologies, with all the inherent integration and compatibility challenges that it represents. The DCT component is typically only partial, overlaid on top of a traditional site-centric trial, representing technical challenges and incremental budgets and timelines.
In contrast, we built and began using our DCT platform for our use in 2017 - for the sole purpose of conducting siteless virtual trials end-to-end. Four years might not seem like a long time, but in the world of DCTs, it is light years, giving us a significant head start on understanding what does and doesn't work when designing and running a virtual trial.
OSP: Could you talk about some of the key challenges trial teams face with their DCTs, around patient engagement?
IJ: Our engagement and retention numbers are typically much higher than traditional trials. We find that patients are often most comfortable reaching out to our study teams via a virtual chat. This chat feature is always available, making our team much more accessible than a traditional site team.
In studies where a patient needs to wear a wearable or sensor to monitor vital signs, there can be some challenges with compliance. For instance, a patient may forget to charge or change the batteries in a device. Or a patient may encounter a device malfunction and not know how to troubleshoot. If any data connection is lost, our platform alerts our virtual site team in real-time, who reach out immediately to re-engage the patient.
We also know that studies with sensors or wearables need a top-notch patient training program to help patients familiarize themselves and get comfortable with the technology before the intervention period begins.
We’ve also had challenges when asking patients to do too much work. If the questionnaires are too complex or when, on hybrid trials, we request too many site visits, we might see compliance drop.
Some patients prefer to go to sites, but in our experience, most do not. Interestingly, we get many questions about whether older patients struggle with the technology for patient reporting, which has not been the case. We recently reviewed the ePRO compliance rates of a study that included participants 50+ and up and found that they were not statistically different from those of the younger participants (91% vs. 94%, respectively).
OSP: Typically, if a patient participant has a question or problem while undergoing a trial at home, how are their questions answered, or problems solved? Could you please describe ObvioHealth’s patient support service and how it might improve upon the participant support commonly used?
IJ: Our virtual site team is a team within ObvioHealth that’s solely dedicated to helping participants and making their experiences as positive as possible. Participants always have the option to text, email, or call our virtual site team through the ObvioHealth app.
Typically, we find that participants text us as the first step, and then if more in-depth conversation is required, our virtual site team will call them. In our last three studies, we received an average of 3,500 chats per study. You might expect a lot of these chat conversations are IT-related. However, when we dug into the data, we found that of the 3,500 chats only about 150 of the questions were related to technology.
We’ve also realized that once our participants know that a real human is answering their questions - an actual person on the other end of the text conversation, as opposed to an automated system - that they’re much more receptive and willing to reach out to us.
Our virtual site team is one of the primary reasons our compliance numbers for clinical studies remain high (an average of 88%). We have implemented automatic notifications that help to remind participants to complete their questionnaires or take their medications. Because we are able to see participant data in real time, our virtual site team is able to immediately notice if a participant starts to drop in adherence. In that case, a member of the team will reach out to that participant personally to discuss and encourage them to get back on track.
OSP: What typically happens if a medical device or sensor they’re using in their at-home trial breaks down or fails?
IJ: First, it’s important that participants receive proper training on how to use the device before the trial starts. It’s also important to give them troubleshooting guides they can refer back to throughout the duration of the trial.
However, devices can malfunction. We encourage our participants to reach out to our virtual site team when this occurs, and they will assist participants by either troubleshooting via phone or sending them a new device. Our team often knows there is an issue even before the participant reaches out because of the data we’re receiving in real-time. When there is a data gap, the virtual team reaches out to see what is going on.
OSP: Why are such patient-centricity concerns important in remote trials?
IJ: It’s really important to ObvioHealth to keep our clinical trials human. While we are incorporating technology that we know helps to reduce the burden on participants, we know they still value human interaction and so do we. Despite the fact that our trials are conducted remotely, we never want our participants to feel like they’re remote or left on an island.
Clinical trials are about finding the evidence that can help to improve people’s health, which is very personal, and that’s why it’s important to always have support on the other side of our platform and app. Ultimately, we know that engaging meaningfully with participants is a virtuous circle that incites them to stay engaged and compliant and delivers better results all around.