Reshaping the Future of Consumer Health through Decentralized and Digitally Enabled Strategies

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.

Click here to download printable PDF

    Futureproofing Consumer Health Studies Using Today’s DCT Strategies

    Today, DCT elements mirror components of a clinical study that traditionally have been completed in a costly face-to-face setting. For example, eConsent and electronic questionnaires have been used in the pharmaceutical industry, replacing the need for paper forms, and enabling the collection of information directly from the patient — often in remote settings. By bringing these solutions into consumer health research, along with telehealth solutions that enable in-home video consultations, enhanced consumer involvement through instant messaging-style chat functions, and direct data collection from wearables, researchers can obtain a real-world view of a product with minimal inconvenience to the consumer.

    Participation in clinical studies where consumers are asked to attend face-to-face clinic visits can become laborious for the consumer. Navigating the commute, wait times, physical assessments, and impact on day-to-day work and life commitments can negatively affect study retention resulting in missing or incomplete data and reducing the robustness of the data collected. DCT studies facilitate better engagement and retention due to the ability to create a near seamless fit with consumers’ lifestyles.

      Operational Approaches

      Those diverse operational approaches shown in Figure 1 allow for a broad spectrum of DCT and hybrid approaches. In the most complete form, a trial can be fully DCT, with enrollment and assessments taking place in a consumer’s home, enabled by end-to-end digital tools and the self-administration of medicines. This model is gradually migrating from small early-phase and non-interventional/post-approval studies toward larger pivotal trials.3

      Figure 1. Operational Approaches to Trial/Study Design

      operational approaches to trial/study design

      While only a small percentage of clinical studies are fully DCT, many studies employ one or more DCT elements, such as ePROs and direct-to-patient supply, based on the suitability of the study population, endpoints, treatment modalities, etc., for these approaches. The industry is experiencing significant increase in uptake because of experience gained during the COVID-19 pandemic.4 The use of electronic diaries and electronic patient-reported outcomes (ePROs) to support validated endpoints around pain and quality of life are now becoming normal practice in consumer health.

      Traditional clinic visits will continue to be needed for complex procedures and specialized screening assessments such as magnetic resonance imaging. In this situation, hybrid trial designs allow other protocol touchpoints to be DCT or closer to the patients—for instance, through mobile clinics and primary-care physicians—whenever possible.

        Enablers for DCT Designs in Consumer Health Research

        Increased comfort with technology. Consumer uptake of digital technology is increasing year to year. Fitness wearables continue to show strong growth as do activities such as Peloton (workouts) and Strava (exercise tracking). Physicians’ and sites’ comfort with remote technologies has also increased because of the COVID-19 pandemic. Clinical-study investigators predict that a threefold increase in remote patient interactions will persist after the pandemic.5

        Importance of convenience. Convenience is increasingly critical to patient enrollment and retention in clinical studies. Patients and physicians expect sponsors to consider patient convenience in trial designs, and investigators in many countries have predicted an increase in patient- centric trial features following the COVID-19 pandemic. This is particularly important in consumer health. Given much of the research is in non-life-threatening conditions, it is vital for successful enrollment that consumers are not inconvenienced outside of their normal day-to-day routine.

        Maturing tools. Tools for remote data gathering such as mobile electronic clinical outcomes assessments (eCOA), novel sensors, actigraphy, camera, voice, and video are increasingly being validated, establishing standards for their broader use. Digital endpoints in consumer health such as cough frequency, sleep quality, stress levels, focus/ attention, mobility, and cardiac fitness are being used more and more as primary endpoints.

        Regulatory acceptance. Prompted by the COVID-19 pandemic, regulators have issued guidance permitting the use of alternative clinical trial approaches, such as remote monitoring, drug shipments to patient homes, home nursing, and alternative sites. Such advice will likely continue to evolve rapidly on a country-by-country basis. As we emerge from the pandemic it is anticipated that much of this guidance will remain and become a key enabler in consumer health research.

        Partner ecosystem. The contract research organizations (CROs) that provide the backbone of clinical-trial services are investing in the emerging set of decentralization elements. Technology innovators are also investing and integrating point solutions to provide sponsors with more seamless and complete offerings.

          Key Benefits of DCT Trials for Consumer Health

          Today’s crowded and highly competitive consumer health market makes meaningful product differentiation a challenge. Compelling claims, supported by scientific evidence, are vital to keep products and brands relevant in the minds of consumers, pharmacists, and other healthcare professionals.

          Three key benefits in using DCT study strategies in consumer health research

          1. Consumers could feel more engaged in the research and be more likely to adhere to study parameters and less likely to drop out when they feel they are not deviating too much from their normal day-to-day routines
          2. Remote studies can help companies innovate the ways they collect evidence, with digital health tools enabling capture of new endpoints and opening new avenues for claims developments
          3. When implemented correctly, DCT research can simplify execution, reducing the time for recruitment and enrollment and potentially reducing costs

          In this whitepaper, we addressed how DCT and digital technologies can enhance the quality, speed, and relevance of data collection. It is time for the consumer health industry to think differently about claims development and embrace the new opportunities available through digital trials. To understand and realize the promise of these new strategies, companies should consider partnering with experts who can offer a strong history and track record of success in planning and executing DCTs, in addition to being experienced with and solely focused on the unique needs and challenges of the consumer health research landscape.

            References

            1. The Connected Consumer of Tomorrow Is Already Here: The Liveworker. Available at: https://www.liveworkstudio.com/insights/the-connected-consumer-of-tomorrow-is already-here/. Accessed October 10, 2021.
            2. US Food and Drug Administration. Real-World Evidence. Available at: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence. Accessed October 10, 2021.
            3. Clinical Leader. The Accelerated Evolution of Clinical Trials in A Pandemic Environment. Source: Oracle Health Sciences. 2020 Nov. Available at: https://www.clinicalleader.com/doc/the-accelerated-evolution-of-clinical-trials-in-a-pandemic-environment-0001. Accessed October 10, 2021.
            4. DIA Global Forum. Round R. COVID-19: The Great Decentralized Clinical Trials Accelerator. 2020 Sep. Available at: https://globalforum.diaglobal.org/issue/september-2020/covid-19-the-great-decentralized-clinical-trials-accelerator/. Accessed October 10, 2021.
            5. McKinsey & Company. How COVID-19 has Pushed Companies Over the Technology Tipping Point – and Transformed Business Forever. 2020 Oct. Available at: https://www.mckinsey.com/business-functions/strategy-and-corporate-finance/our-insights/how-covid-19-has-pushed-companies-over-the-technology-tipping-point-and-transformed-business-forever. Accessed October 10, 2021.