FALL 2021, THE EVIDENCE FORUM, WHITE PAPER
 Christopher Morris, BSc (Hons) Senior Director, Consumer Health Evidera, a PPD business |  Mariah Baltezegar, MBA Vice President and Head, Consumer Health & PPA Study Innovation Real-World Evidence Evidera, a PPD business |
Background
Consumers in 2021 are increasingly connected and the COVID-19 pandemic has only served to increase the need to stay connected. Consumers communicate, socialize, shop, and control their environment and health management using various technologies such as online apps, fitness wearables, and smart appliances all the time. They want services that make their lives simpler and more manageable. It is, in part, for this reason that clinical studies of consumer health products that are supported by digital and decentralized (DCT) technologies are attractive to participants. Since they are created to be consumer-centric, digital and DCT study technologies and services have created a spectrum of new clinical study models, ranging from digitally enabled studies to entirely DCT approaches, which effectively remove most of the labor-intensive inefficiencies of traditional studies.1
The use of computers, mobile devices, wearables, and other biosensors to gather and store huge amounts of health-related data has been rapidly accelerating. These data hold the potential to generate deeper health-related insights allowing us to better design and conduct clinical studies to answer questions previously thought unanswerable. Additionally, with the development of sophisticated new data analysis platforms, researchers are better able to analyze these data and apply the results of that analysis to product development and approval.2
DCT research methods are not new to the consumer healthcare industry. Primary market research exploring new potential claims, such as the speed or duration of action of a product, or to evaluate the impact of new packaging or a new brand name has long been conducted utilizing online digital survey methods. However, more scientifically robust research in the consumer health space has been restricted by cost and time limitations driven by the marketing imperative to bring that claim to market rapidly.
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