Digital disruption. These words are used to describe how technology changed the way we communicate, shop, and consume information. Other industries – like finance, banking, and entertainment – have already faced major changes in their business models due to these changes. But unlike these consumer-driven industries, funding for clinical research usually depends on grants and the status quo is harder to challenge.
In this issue we’ll look at the changing clinical research landscape, the emerging opportunities in digital clinical trials, and the main challenges to overcome. As with so many things, expecting the change is halfway to being prepared for it.
USING DIGITAL TECHNOLOGY TO GATHER DATA
The way clinical trials are conducted is changing. Both patients and clinicians advocate for better and faster evidence to inform decisions. Mobile technology allows a two-way, real-time communication with the rest of the world and are the first stepping stone of change in clinical trials.
The development of wearables such as Apple Watch and Fitbit allow easy recording of vital signs such as heart rate, exercise and movement. In this PharmaVoice article, author Denise Myshko explains how “Wearables are improving the clinical trial experience for patients and satisfying the need to collect data for real-world use studies.” Using wearable devices permits the generation of patient-centric data in real time and has several advantages for patients, such as decreasing or eliminating follow-up visits to research centres. The article goes on to describe the evolution of wearables and how they improved compliance with regulatory requirements, what companies are already using wearables in their research, and the insights produced from the data collected with this new technology.
Smartphones are always with us, so it’s no surprise that some companies developed apps that are used to collect patient-reported outcomes. This enables a more patient-centric approach to a clinical trial, and “the result can be something as simple as an app that reminds them to take their medicine or getting a patient’s permission to track their symptoms”, according to Dawn Anderson, managing director of life sciences strategy and operations in the R&D practice at Deloitte. You can read here the full interview conducted by Ed Miseta for Clinical Leader website. On the forefront of this innovation is Apple, which created a framework that allows developers to create custom apps for clinical research, ongoing patient care, and even diagnosis of certain conditions.
New technology allows for more patients to be included in clinical trials, because it’s easier for them to provide information to researchers, and patients from remote areas can now more easily participate in trials. For pharma, biotech and medical devices companies, this means they can gather more data with less costs, but challenges include re-thinking their IT structure, creating secure cloud data storage, and using SaaS (software as a service) products efficiently to manage digital clinical trials.
For professionals this means a new way to work, and probably emerging roles within the digital side of research. Working remotely becomes a reality for clinical research associates, and managing virtual trials a new challenge.
Alro, Rikke Havner, Marie-Louise Krogh, and Claire Gudex. “Systematic Hospital Collection of Patient-Reported Outcome Data via Patient Apps.” Medical Writing 27 (December 1, 2018): 30–34.
“Digital Clinical Trials Workshop: Creating a Vision for the Future | National Heart, Lung, and Blood Institute (NHLBI).” Accessed January 13, 2020. https://www.nhlbi.nih.gov/events/2019/digital-clinical-trials-workshop-creating-vision-future.
“Is Your Clinical Trial Ready To Go Digital.” Accessed January 13, 2020. https://www.clinicalleader.com/doc/is-your-clinical-trial-ready-to-go-digital-0001.
Apple. “ResearchKit and CareKit.” Accessed January 13, 2020. http://www.apple.com/researchkit/.
Steinhubl, Steven R., Dana L. Wolff-Hughes, Wendy Nilsen, Erin Iturriaga, and Robert M. Califf. “Digital Clinical Trials: Creating a Vision for the Future.” Npj Digital Medicine 2, no. 1 (December 12, 2019): 1–3. https://doi.org/10.1038/s41746-019-0203-0.
PharmaVOICE. “Wearables In Clinical Trials.” Accessed January 13, 2020. https://www.pharmavoice.com/article/2019-03-wearables/.
Resources of the week
The first fully digital clinical trial encouraged physical activity, using an app to remind participants to exercise more. Conducted by Stanford scientists and harnessing Apple technology, the study helped people to get more engaged with their health.
For an end-of-year review and digital health predictions for 2020, I encourage you to listen to this episode of the MM&M podcast, where Ritesh Patel, chief digital officer for Health at Ogilvy shares his wisdom.
Other articles that may interest you: