Take selling a home, for example. Nowadays, you can accomplish all the sales steps via text message and electronic signatures. On closing day, you can complete a document from the snowy mountains of a vacation cabin that attests to your agreement to sell from hundreds of miles away. If valuable assets like homes can be sold online, then it should be assumed that everything else can be accomplished from afar using technology.
Truth? Not necessarily. Somehow, clinical trials dodged the modern shift to technology and only in 2020 did they finally begin to catch up. This begs a few questions – why has the clinical trial industry been so slow to adopt technology, what does the shift toward digital processes look like and how is the COVID-19 pandemic accelerating this change?
Why has the clinical trial industry been slow to adopt technology?
Technology moves fast compared to the time it takes to run a clinical trial. The average clinical trial takes around six to seven years to complete. To put that in perspective, the internet was invented in 1974 and Artificial Intelligence (AI) arrived in 2017. If we hypothesize that there were back-to-back trials since 1974 that only allows for 6.5 trials since the internet began.
Another reason the clinical trial industry has been slow to adopt technology is perceived risk versus reward. Let’s use Electronic Health Records (EHRs) as an example. Why would the clinical industry rapidly adopt EHRs and not technology for research? The difference is the reward. The government offered incentives ($27 billion) in 2009 to encourage the adoption of EHRs. Starting in 2015, the government charged late adopters penalties. Similar incentives have not occurred in clinical research (Teaser – until COVID-19).
Pioneering Change in Clinical Research
In January of 2016, clinical research teams across the US discussed the benefits of electronic regulatory documents. Improved visibility and reduced risk of errors were two hot topics, but rewards weren’t the only things discussed.
Clinical research sites repeatedly said, “The FDA and sponsors will never allow us to do this (electronic regulatory binders).” But the FDA was and is in favor of advancing clinical trials through technology. In 2019, those same teams realized they not only needed technology platforms, like eRegulatory, but they needed them now to be efficient and remain competitive in site selection. This shift was pivotal.
Often, the adoption of a revolutionary new technology in clinical trials points to a significant triggering event that causes the majority of people to test and adopt the solution. This trend is true of any industry. In clinical research, triggering events range from the FDA or EMA issuing new guidance or, as is the case today, a global pandemic that disrupted an entire industry’s operations.
Enter: The COVID-19 Pandemic
COVID-19 highlighted major needs for clinical research advancements. On-site restrictions caused a critical demand for remote site access and monitoring in order to reduce growing trial delays. eConsent also became particularly important. Allowing patients to participate in meaningful research for the pandemic was challenging. Critical? Yes. Easy? No. Despite being essential. As a result, many sites, CROs and sponsors had to think outside the box.
A 2020 survey of more than 240 industry leaders revealed that now over 60% of both sponsors and sites experience greater than 50% acceptance of remote site monitoring solutions with the partners they work with. Change is no longer optional, but necessary.
What Does Change Look Like?
There are three key areas of research tool advancements that will yield high reward with tolerable risk.
1. eConsent: Rewards in this category include participant comprehension, engagement and retention as well as enrollment speed and increased economic and geographic diversity in the participant population.
2. Partially Virtual Trials:This includes participant selection, consenting, site qualification, initiation, protocol training, study progression and FDA inspections.
3. ePro and eSource: Key drivers and perceived rewards include data integrity and lowering the friction points for trial participation.
These three big areas for advancement aren’t the only areas that clinical research professionals are looking to improve. A recent survey of more than 200 clinical research professionals shows us exactly what changes to expect in 2021 and beyond. Further, 80% of people responded expect most, or all, monitoring will be completed remotely by 2023.
The challenges of 2020 pushed the industry to make needed changes and showed sponsors and sites that working together is where the magic happens. As we head further into 2021, we can expect to see sponsors and sites collaborating and creating solutions that benefit both organizations. These changes will, without a doubt, make a lasting impact on the industry, and in parallel society as a whole, for the foreseeable future.
Angela Gill Nelms brings more than 15 years of clinical research experience in over 50 trials partnered with more than 60 US and European hospitals. As the Chief Operating Officer at Florence Healthcare, Angela is charged with strategically guiding the direction of the company, creating a “Best Place to Work” culture, driving core products, ensuring successful product implementation, delivering white glove customer service and making sure clinical teams around the world are successful. In 2016, Florence had one customer and now serves 7,300+ clinical researchers through its innovation.