More than 500 new COVID-19 related clinical trials have been registered as of the end of April. The race to find a COVID-19 vaccine is on and the public spotlight is on clinical trials. Strangely named drugs such as Hydroxychloroquine and Remdesivir have become household names and are featured and debated regularly on the 24-hour news channels.
The pressure to find a cure is intense. The locked-down world does not want to hear that at best, we may find a vaccine sometime in 2021. What the world doesn’t realize is that 2021 would be nothing short of a miracle timeline for a new drug. What the experts know, the general public doesn’t want to hear: It usually takes several years to develop, test, prove, and manufacture a drug for safe use.
Unfortunately, these are not normal times. The daily human and economic toll is upheaving the long practiced, structured process of drug development. The FDA is fast-tracking approvals and processes in an effort to allow research and manufacturers to move quickly. While we have seen some progress, the process to test a new drug before it can be approved and manufactured at scale is typically a lengthy, manual process.
Challenges Administering Trials in the Face of Unprecedented Urgency
A typical therapy must undergo several multi-year phases to demonstrate efficacy and safety. For each phase, a group of participants must be identified, recruited, qualified, and enrolled. In many cases, the enrollment process involves in-person screening, consent, lab tests, and evaluations. Sometimes these can be handled via phone. Most of the time, the recruitment and patient interactions are handled by clinical research coordinators at dozens of trial sites. It’s a complex process with many touchpoints.
Sites struggle to identify patients, educate them about trial benefits, and enroll them in studies. In fact, 86% of clinical trials are delayed 1-6 months because they can’t meet their recruitment targets on time. 15-20% of trials never even enroll a single patient and are forced to close.
The challenge doesn’t stop at enrollment. Once the trial is underway, patients are monitored and evaluated (often daily) for therapy efficacy, side effects, and impact on the quality of life. CRCs and patients alike burn out from the repetitive monotony of never-ending phone or in-person interviews. On average, 30% of patients drop out after enrollment, often because trial participation is overly burdensome or complicated. If patient numbers dwindle below the minimum thresholds for statistical viability, study timelines must be extended, delaying time to therapy.
Now consider the fact that a COVID-19 vaccine isn’t for a small subset of the population with a rare disease, but rather for everyone on the planet. So, while that might make finding volunteers easier, it will likely result in thousands of trials involving hundreds of thousands of patients across the globe. Coordinating, monitoring, and administering trial protocols for large patient populations, on accelerated timelines, will require millions of hours of effort.
Speed and Scale through Patient Engagement Technology
Researchers know the stakes and will do everything they can to get the answers they need to find a cure. There are countless, incredible technologies at their disposal to help with the scientific discovery aspects of creating a new drug. But what about the heavy lifting of patient coordination, administration, and engagement for accelerated, large trials? How will we quickly recruit thousands of clinical research coordinators (CRCs) even as hospital systems and clinic resources are overwhelmed?
There appears to be an opportunity for more speed, efficiency and scale that is not being fully exploited in the clinical trials space. Many of the published abstracts and stories about trials tend to have one thing in common – lots of time-consuming, manual checks, conducted by human teams. Examples like this are common in the abstracts:
“The study, which is aiming to enroll 6,000 people, is also being conducted remotely, with participants receiving the drug in the mail and follow-up visits done via phone or video.”
“Study coordinators will be in contact directly with those accepted to schedule an initial enrollment visit. Once volunteers provide a blood sample, the study subjects will receive vials with unidentified, specific pills to take over the next eight weeks.”
Now, imagine if screening patients, scheduling clinic visits, reminding patients to adhere to trial protocols, and collecting patient-reported outcomes were delivered by a conversational digital assistant (a chatbot), instead of a CRC reading an IRB-approved script. What if we could automate 80% of the effort needed to manage a clinical trial protocol?
Augmenting CRC teams with smart chatbots that can handle complex outreach and data collection tasks with operational precision and consistency can deliver a 100x scale. Automating scripted, repetitive workflows to digital assistants allow CRCs and care teams to work at ‘top-of-license’, focusing on higher-value activities like high-risk patient follow up.
When it comes to creating a pandemic-level cure, maybe the time has come to think about scale and automation. While conversational technology will never replace the brilliant human minds that are running these initiatives, its ability to automate interactions with large patient panels in a clinically precise manner can compress clinical trial timelines, reduce administrative overhead, and accelerate time to therapy.
Chatbots have proven to be effective ways to engage patients in healthcare, they can do the same in a clinical trial. It’s what patients prefer. It’s what the world needs right now.
About Greg Kefer, Chief Marketing Officer, LifeLink
Greg, as CMO at LifeLink, is responsible for strategy, branding, communications, and demand generation at the healthcare chatbot technology company. Large hospitals, pharmaceutical companies, and healthcare service providers use LifeLink bots to engage patient populations at scale, across a spectrum of workflows and scenarios.