Biomedical research is entering a new era of “patient power” with seismic opportunity for people living with disease to partner with scientists to influence research design and shape patient-relevant outcomes. Technology now allows thousands to contribute vast volumes of data on their lived experience of disease: from symptoms and quality of life to treatment satisfaction and research participation preferences. This data is collectively known as patient-reported outcomes, or PROs, and holds the power to redefine therapeutic priorities, influence funding streams and optimize trial design.
For example, regulators (such as the Food and Drug Administration) and payers (Medicare/Medicaid/insurers) traditionally have relied on biological markers of disease to make decisions about approving and reimbursing new therapies. Today they increasingly rely on PROs to fully understand health care and the potential impact of new treatments in real-world clinical practice.
The Michael J. Fox Foundation has established Fox Insight, a digital platform and dynamic online clinical study, to build a large, diverse cohort of people with Parkinson’s and age-matched control volunteers. The study seeks to enroll tens of thousands of diverse participants, which would make it the largest and most representative Parkinson’s research study to date. A large, diverse cohort will lead to more accurate, generalizable and powerful PROs.
It’s important to note: While patient-reported outcomes supplement biological measures of disease and therapeutic impact, they are not a replacement. Fox Insight complements traditional, in-person research studies with scale and accessibility, overcoming traditional barriers to research participation such as geography and mobility limitations. Curated, de-identified (without names or email addresses, for example) Fox Insight data will be made available to researchers worldwide in real time. Access to the Fox Insight cohort and its data can drastically reduce research timelines, advancing new therapies faster.
Fox Insight launched in beta in March 2015. More than 5,000 volunteers (80 percent with Parkinson’s diagnosis) contributed data that helped optimize the study experience and utility of data for researchers before the study’s formal launch in April 2017.
Please participate by sharing your health-related experiences.
Fox Insight compiles health and disease information entered when participants first join the study and every 90 days thereafter. Email prompts and your Fox Insight dashboard will tell you when it’s time for your next study visit: a series of online questionnaires that may ask about symptoms, experiences performing daily tasks, medical and family history, or other topics related to your health. All Fox Insight activities adhere to regulatory/institutional review board standards for a clinical study.
It’s important you keep coming back to complete study visits. Seeing health patterns and trends over time from thousands of individuals – and capturing recent experiences -- will help capture accurate and powerful PROs.
In addition to completing regular study visits, you may be offered ways to provide additional data. These may include surveys to answer specific questions about the lived experience of Parkinson’s or sub-studies leveraging remote data collection mechanisms such as using mobile technologies (smartwatches and smartphones) for the passive capture of real-time, objective data on daily life with PD. In addition, Fox Insight is linked to the MJFF online smart-matching tool Fox Trial Finder, helping users find other clinical studies (in-person and online) that may also be a good match for them based on medical history and geography.
We’re always looking for ways to grow the reach and impact of your participation in Fox Insight, so keep an eye on your email and on the Related Research page for new opportunities to contribute.
By participating in Fox Insight, you’re part of a growing community of people with Parkinson’s, their loved ones and Parkinson’s researchers. On the Community Page, view a snapshot of the aggregate data from all Fox Insight users (e.g., most bothersome and frequent symptoms, family neurological history). The Research Publications page shows how scientists are using Fox Insight data to integrate PROs in research and accelerate scientific discovery. The Tools page has resources to help prepare for upcoming visits with a physician such as an appointment reminder and physician report.
Throughout your participation in Fox Insight, you will meet our virtual clinical coordinator Sally, who will send you email reminders, share news of new study features and guide you through your study visits.
If you have any questions throughout your participation, you can always contact the Fox Insight team.
Thank you for contributing to Parkinson’s research. We’re glad to have you join and are grateful for your participation in patient-powered research!