Decentralized clinical research will be a paradigm shift

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Zeenia Framroze, Director of Strategy and Business Operations at Sharecare

The field of clinical research is on the precipice of change, and for good reason. Traditional clinical trials and processes are primarily limited to sterile, isolated clinical settings that are often small-scale and provider-centered. Tomorrow’s researchers, however, are already identifying new precise and effective methods to carry out and make sense of their work, after concluding that current clinical research models are not capturing participants ’real-world lived experiences in a way that effective.

The problem with the status quo

There are a myriad of challenges posed by the status quo in clinical research. First, most data from clinical trials are collected only within the healthcare system. Electronic medical records (EMR), provider surveys or evaluations, and clinical examinations or evaluations are examples of this, and may be homogeneous in that they illuminate only a portion of the health influences of the broader lived experience of a patient. Beyond clinical data, external factors related to one’s own experience such as levels of physical activity, social determinants of health, and environmental exposures (e.g., allergens and pollution) may be critical to understanding the patient’s health in a more holistic way. Often, these real-world data can help predict how different patient populations may interact with a digital health drug, product, or resource, and in addition, they may alert researchers to possible side effects prior to the developmental process.

Second, the conventional structure of clinical research often invites unintentional bias at points of contact ranging from contracting trials to delivery of the marketed product. Regardless of whether a study is intervention or observational, people who cannot commit to revisiting the test site routinely for any number of reasons are excluded from the default studies. Lack of transportation resources (including gasoline and parking costs) to travel to and from the study site can make attendance unfeasible, unfavorable, or impossible. As another example, inadequate insurance coverage for research visits may impose a financial burden on patients that may deter participation. Lack of time or flexibility to attend on-site appointments during the work week can also create tension between work obligation (and therefore financial security) and participation. And ultimately, these seemingly small obstacles give way to socioeconomic and racial bias within clinical trials.

Real-world decentralized research offers solutions and opportunities

Fortunately, advances in digital health and decentralized research have allowed researchers to overcome some of the key challenges associated with traditional methods. Decentralized clinical trials (DCTs) leverage resources such as wearables and other patient-generated data sources to focus more on the consumer, leading to greater participant access, more accurate results, and accelerated clinical developments. While evaluations in the clinic offer researchers a “snapshot” of an individual’s health time, the continuous monitoring that decentralized methods make possible offers them all the “winding”.

He Covid-19 pandemic made in-person clinical research fundamentally impossible for many. This forced researchers to rethink their methods, especially when it became clear that COVID-19-infected people continued to suffer from COVID-19 symptoms long outside of their hospitalization or clinical experiences. Without the infrastructure, labor, technology, or training to operate remotely, many medical institutes temporarily close or postpone projects. However, some took the opportunity to be at the forefront, conducting research visits through virtual observational research.

Even more techniques that transcend boundaries such as federated learning, zero-confidence frameworks, cutting-edge computing, and other advances in technology have helped broaden the scope and accelerate the pace of trials far beyond obsolete research methods. in person. Federated learning allows for the complete collection and processing of patient information without moving the data beyond the devices on which patient data is stored, reducing data security and patient privacy concerns. Similarly, edge computing ensures that custom data is stored in the data source (i.e., the smartphone) and does not need to be transferred to a centralized data processing server or warehouse. Technologies such as these, which focus on participants ’privacy and security, accelerate the adoption of virtual clinical research.

Participant-centered studies provide rich real-world data

With the guarantee of patient privacy and data security, now is the time to replace old institution-based clinical trials with digital, decentralized platforms that will unlock unbiased and broader clinical research.

Decentralized studies, which use innovative, multidimensional platforms, can synthesize the broadest influences on health and well-being. Unlike institutional data only, decentralized research can extract patient-generated and informed health data, such as physical activity levels, vital signs, sleep patterns, and nutrition; and these real-world data can provide deeper dimensions to our views on an individual’s health and how they experience a product or intervention. It can also incorporate significant data related to the environments in which patients live, such as walkability scores, access to health care, pollen counts, moisture levels, or the presence of toxic chemicals such as asbestos or the smoke of forest fires.

Virtual trials conducted on platforms that are easily integrated into patient-friendly technologies are much more flexible and accessible than those based only on centralized institutional environments. This can improve the recruitment of patients heading for a trial by removing barriers to their enrollment, such as logistics related to visit attendance, by allowing web-based or mobile pre-checks. It can also promote patient participation and retention throughout the trial by providing self-assessment and self-report tools that are intuitive, practical, and convenient, as well as familiar visualizations and notifications about their compliance. These tools alone can help lift the veil of bias in contemporary clinical research.

From “Nice to have” to “Need to have”.

We are likely to see more research institutions following in the footsteps of those moving to decentralized research for a number of reasons. As studies conducted during the COVID-19 pandemic are updated, the benefits of remote virtual trials that allow for technological improvements will become more frequent. It is likely that as research subjects become more digitally native, they will demand consistency and accessibility in a consistent manner in a patient-centered manner; Gathering real-world evidence and data by taking advantage of how and where people live, on their smartphones, will be the optimal way. It is no longer a “friendly to have” decentralized clinical research, but a “necessary” one, it will be a paradigm shift trend for the industry.


About Zeenia Framroze

Zeenia supports clinical research initiatives a Sharecare as director of strategy and operations. In this role, he directs market and product strategies for Smart Omix, a smartphone-based solution for real-world decentralized research. With a background in political theory and social policy from Harvard University and Oxford University, she is especially interested in how streamlining real-world evidence gathering can contribute to precision medicine, the successful evaluation of social and health interventions and increase diversity. participation in clinical research. He joined Sharecare in 2020 through the acquisition of doc.ai, where he served as head of sales and customer success, working with health plans, pharmaceutical and life sciences companies and suppliers.




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