Before the pandemic, many sponsors were hesitant to incorporate a decentralized clinical trial (DCT) element into their studies. They are concerned that technology-driven research may not meet regulatory standards and that data captured on personal devices is not secure.
Covid-19 has changed all that. The shutdown of the site forced sponsors to embrace telemedicine, wearables and remote monitoring. It was a difficult transition, but it helped life sciences companies see the value that DCT technology could bring to trial design.
This experience has accelerated technology adoption in the industry over the years, and we expect the transformation to continue in the coming year.one Report It was found that in 2019, only 38% of industry professionals expect virtual trials to be a major part of their portfolios. But a year later, that number jumped to 100 percent.
Pandemic-Driven Innovation
During the pandemic, the need for pragmatism has driven initial adoption of the technology.
With very limited access to patients and the accelerated time to launch Covid-related trials, technology is a lifeline that sponsors cannot ignore. It helps them continue to advance existing trials and rapidly accelerate recruitment for vaccine and treatment trials.In Janssen’s Covid-19 Phase 3 vaccine study, sponsors were able to recruit 40,000 patients in less than two months. Hiring has been accelerated through the use of telehealth technology, virtual supervision and digital patient engagement strategies.
We expect that the benefits that sponsors experience in these trials will make them more willing to consider new technologies that promise to make trials less expensive and more accessible to all patient populations.
While it’s always unclear what the future holds, these are the technologies we expect to see more of in 2022.
personal device
Sponsors have historically been slow to let consumers use their own devices for data collection due to concerns about data security and a lack of controls. This has led many of them to spend millions of dollars providing trial patients with cumbersome, often outdated equipment to record relevant data. The need to jumpstart trials in the midst of a pandemic means they must put those concerns aside and give patients the freedom to complete electronic consent forms, electronic clinical outcome assessments (eCOAs), questionnaires and other data collection tasks on their own devices.
The data collection app has proven to be as safe and fair to use on a patient’s smartphone as it is on dedicated clinical trial equipment. And because patients carry their phones with them, they are more likely to respond to alerts reminding them to complete reporting tasks. These benefits not only improve the quality and consistency of the data collected, but also reduce the time and cost of trials because sponsors do not have to wait weeks to obtain thousands of devices and ship them to patient populations. As a result, sponsors today often look to include bring-your-own-device (BYOD) options in future research, suggesting the industry is finally ready to make personal devices an acceptable tool in pilot programs.
Intelligent voice assistant
For many consumers, smart assistants such as Alexa, Cortana, Siri, etc. are already integrated into their daily lives. These tools are like virtual assistants that can select music, research queries and read texts.
It’s not an easy task to think that these assistants will soon have a role in clinical research. Simple voice access provides a compelling tool for patients who cannot use their smartphones to ask questions or record data. For example, consider a patient studying migraine treatment. The pain and nausea of a migraine can be exacerbated by bright light or the need to concentrate, making it impractical to use a smartphone to record symptoms. But if patients could lie in the dark and tell Alexa about these symptoms, it would give them a channel to share their experiences with investigators in real-time, not after the incident subsided.
Conversational chatbot
The current generation of chatbots uses artificial intelligence (AI) to communicate with consumers using natural language and can answer questions with high accuracy. They often include built-in verification steps to ensure the data exchanged is accurate and ask consumers if additional human assistance is required.
These tools are already commonly used to respond to medical information inquiries, and they will soon become part of the clinical trial environment. Like intelligent assistants, AI-driven conversational chatbots can provide patients and caregivers a channel to ask questions and record data verbally at any time of the day or night.
In the elderly population, those with mild motor skills problems or visual impairment, this conversational technology could make clinical trial interactions more accessible and further remove barriers to participation.
Consumer Wearables
crowd of people Fitbits, Apple Watches, and other health trackers that automatically collect valuable healthcare data throughout the day are already worn. These real-world data points can provide sponsors with additional insights into patient mobility, sleep patterns, heart rate, movement, gait and other health statistics.
Sponsors are already using medical-grade wearables in clinical trials to capture specific patient outcomes. Including data from consumer wearables could give them access to more robust data streams without having to tune additional equipment or require patients to manually track and record these data points.
Environmental data
Ambient Intelligence (AmI) uses sensors and artificial intelligence to monitor a patient’s environment and care. These tools are already ““Smart Ward” Visitors are alerted if they fail to sanitize their hands, or if they see clues about patient behavior that could indicate a health crisis. The sensor could be utilized in the homes of trial participants to track environmental factors associated with disease and treatment.
In some cases, the data may already exist. For example, utilities capture detailed data on individual user usage and local trends, tracking changes in water and energy usage across seasons and across demographics. Consumers with smart thermostats can capture detailed data about their home environment, including temperature, humidity, energy usage and traffic patterns. Some of this data may be valuable to clinical researchers. For example, a person with anemia may raise their body temperature to relieve the cold, while a surge in water intake may be a sign of untreated diabetes. This is another way to use existing real-world data to better understand the patient experience.
All of these technologies already exist, and most are designed by leading technology companies with the talent and resources to create safe, reliable, and highly intelligent data capture tools. The life sciences industry has an opportunity to benefit from their innovations instead of trying to reinvent that wheel.
The pandemic has helped the industry overcome initial barriers to using consumer technology to access clinical data, and we are already seeing the benefits it can bring. The question now is how we will apply these experiences in the future to obtain more reliable data while improving the patient experience.
Photo: gabort71, Getty Images
