How Technology in Clinical Trials Benefits Patients and Sponsors
How Technology in Clinical Trials Benefits Both Sponsors and Patients
The modernization of the clinical trial process is being driven in large part due to advances in technology. Tools such as electronic clinical outcome assessment (eCOA) and electronic patient reported outcome (ePRO) allow for both remote and real-time data capture. Wearable devices and even ingestible devices also collect data on the use and impact of a medication in a patient’s body and automatically send that information to study investigators.
The plethora of technology products has benefited both companies and patients. In 2017, the Tufts Center for the Study of Drug Development found that 70% of organizations surveyed were using tools such as eCOA and ePRO. Market information and analytic firm Beroe predicts that the R&D IT market will grow 20% annually between now and 2023. In order to maximize use of technology, sponsors can look to patient technological preferences and reorient trials so that they maximize patient centricity.
For example, a 2019 study found that while 95% of patients were comfortable using a wearable device in a trial, for ingestibles, the figure was only 73%. Other studies have looked at whether participants prefer to use their own devices, such as a smartphone, as part of a trial or one issued by the sponsor. One study found that trials in which patients used their own devices saw participants use remote monitoring tools more frequently and for longer periods, which likely leads to better data for researchers.
One element to keep in mind is not to overwhelm patients. For example, a single trial may utilize many different phone apps or software applications from different suppliers. When designing a trial utilizing technology, it’s critical to have a holistic approach for patients, says Craig Lipset, founder of Clinical Innovation Partners and former head of clinical innovation at Pfizer. “We have to have a consistent user experience just like any enterprise should.”
Trials themselves need to change to ensure technology is used well. Firms can’t just apply tools to improve individual elements of clinical trials. The technology should be used as a way to rethink how the trials are run, and the patient experience should be a guide.
In using new technology, companies also need to expand their definition of what constitutes a successful clinical trial. Takeda, for example, is developing a clinical trial patient burden index that looks beyond a return on investment or how quickly a trial is completed. “If we lower that burden, we might start to be able to measure how much faster we’re able to recruit patients and have them participate through to the end of the study,” notes Jessica Scott, head of R&D Patient Engagement at Takeda.
In the past, patient burden has been qualitatively assessed, but this has not provided a systematic evaluation of the reality of a patient’s overall clinical trial experience. Understanding and evaluating patient burden can help meet the challenges of patient recruitment, retention, and adherence. Medidata offers a patient burden index tool for improving trial design, downstream operations, and patient centricity.
Ultimately, technology may lead to more customization of the patient experience in a clinical trial, according to patient advocate and metastatic melanoma survivor TJ Sharpe. “What’s really going to push clinical research into [the future] is the ability to bring trials to the patient rather than the other way around.”
Read the report from the Economist Intelligence Unit, State of Patient Centricity 2020: Advancing from Patient-first Intentions to True Co-creation, sponsored by Medidata.
Have you registered yet for Medidata NEXT Global 2020? The virtual conference will be held October 27-29, 2020, and the theme is Patient First. Jessica Scott, Emily Kramer-Golinkoff, and Emily Wasik will speak in a keynote panel. Register here.