Michael J. Fox Foundation significantly expands Parkinson’s study

By Jenni Spinner

- Last updated on GMT

(Sherbrooke Connectivity Imaging Lab (SCIL)/iStock via Getty Images Plus)
(Sherbrooke Connectivity Imaging Lab (SCIL)/iStock via Getty Images Plus)

Related tags neurologic Parkinson's disease Research Patient recruitment Patient reported outcomes

The Parkinson’s Progression Markers Initiative, built using Evidation Health’s research platform, aims to triple enrollment and recruit online participants.

The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has announced a significant expansion of its Parkinson’s Progression Markers Initiative (PPMI). The organization reports it is reopening the $450m USD study (built with Evidation Health research platform) triple enrollment across nearly 50 sites sited in 12 countries, and to recruit 100,000 online participants; it has enrolled 1,400 participants since its launch in 2010.

To learn more about the expansion, the foundation’s goals, the technology driving the study, and what it might mean for Parkinson’s researchers and patients, Outsourcing-Pharma connected with two experts:

  • Sohini Chowdhury, deputy CEO and head of research for the Michael J. Fox Foundation
  • Christine Lemke, CEO and co-founder of Evidation

OSP: Could you please share how the Fox Foundation and Evidation came to work together—have you partnered on any projects with them before, or any other notable organizations?

CL: Evidation and the Michael J. Fox Foundation for Parkinson’s Research worked hand in hand to design a privacy-conscious, easy-to-use study experience for the online portion of the Parkinson’s Progression Markers Initiative. Evidation has deep experience designing longitudinal studies that harness real-world data including electronic patient-reported outcomes — we’ve done hundreds of studies across real-world therapeutic areas.

Evidation and MJFF previously worked together on other projects including the BEAT-PD (Biomarker and Endpoint Assessment to Track Parkinson’s Disease) DREAM Challenge, which aimed to generate ideas around new biomarkers for predicting the severity of Parkinson’s disease. We are proud to continue collaborating with MJFF on the expansion of the Parkinson’s Progression Markers Initiative (PPMI) to help advance our understanding, diagnosis, and treatment of Parkinson’s disease.

Evidation works with a variety of organizations across the public and private sector, including biopharma companies, academic institutions, government institutions, public health organizations, and medical specialty societies. Launched as a research platform powered by individuals and their permissioned health data, Evidation has been the basis for pioneering studies across diverse topics, from COVID-19 and Alzheimer’s disease to chronic pain and respiratory conditions.

OSP: Please describe the Evidation technology the PPMI is built upon, and how it will benefit Parkinson’s researchers and patients.

Christine Lemke, CEO and co-founder, Evidation Health

CL: Evidation is a two-sided platform connecting individuals and enterprises. On the consumer side, we provide value to over 4m individuals across the US who are highly motivated to participate in research including testing of digital health programs. On the enterprise side, Evidation provides biopharma, med-tech, big tech, academic institutions, professional societies, and government partners the ability to: generate evidence; and design, test, and deploy programs that motivate evidence-based action.

Evidation’s web-based platform connecting individuals and enterprises is ideally suited for PPMI and other research around Parkinson’s disease. Our platform allows for ongoing online collection of cross-sectional and longitudinal data from participants with and without PD, as well as modification of the participant experience as needed. This is critical, as Parkinson’s disease is progressive in nature and thus research often needs to engage participants at scale for multiple years to fulfill study objectives.

PPMI participants are encouraged to accomplish a set of activities every 90 days to help researchers assess their individual risk of Parkinson’s and to help them to select participants to engage in additional diagnostic testing. A combination of these self-reported symptoms and diagnostic test results will enable researchers to more effectively identify and assess Parkinson’s disease progression.

OSP: Could you please share a little detail about the online enrollment of the 100K folks with or without a Parkinson’s diagnosis, and why this is particularly notable and innovative?

CL: We will be increasing our study size—scaling the study while expanding the type of data individuals can share—many will be able to provide information on their activities of the day living in a way they never have before. By scaling and expanding our study, we create a robust data set that we hope can better characterize Parkinson’s disease, understand its onset and progression, and advance treatment. Individuals may enroll wherever they live in the US and are not limited by proximity to a study site.

To better understand risk factors and disease onset, it’s important to enroll healthy individuals—not just so we better understand why someone might get PD when another person may not, but also if a healthy individual does eventually get Parkinson’s disease, we can learn the earliest risk factors, signs, and symptoms that will help get them treatment earlier and faster. Better understanding these markers of disease onset also has the potential to help us develop therapies faster.

OSP: Please share your thoughts on how Parkinson’s research and discovery of potential treatments have evolved in recent years

Sohini Chowdhury, deputy CEO and head of research, Michael J. Fox Foundation

SC: The Michael J. Fox Foundation’s expansion of its landmark clinical study, the Parkinson’s Progression Markers Initiative, is one of the best signals of the sheer momentum in research to date. When the Foundation launched in 2000, there was little activity in Parkinson’s drug development. In the early days of the Foundation, we set out to make as many strategic investments as possible in promising targets to validate new findings in Parkinson’s biology and enable therapeutic approaches by building tools and resources for researchers and biopharma.

Since launching in 2010, PPMI has sought to identify objective biological markers of Parkinson’s onset and progression — critical tools for the development of new and better treatments to transform patients’ lives. Now taking on the next step, we’re building on its first decade of discoveries to study the full spectrum of disease — those not diagnosed; the newly diagnosed; and those with progressing disease.

This is about detecting Parkinson’s earlier so we can treat it sooner and ultimately, prevent the disease altogether. PPMI has already enrolled and followed more than 1,400 participants to date, and today through harnessing the power of technology online, we’re seeking tens of thousands more to volunteer, including those without a direct Parkinson’s connection.

In the last several years, more than 20 drug trials to slow or stop the progression of Parkinson’s have used PPMI methods and data to transform the robust pipeline of therapies. We remain energized about the possibilities ahead and the community that will help realize new breakthroughs that are right around the corner.

OSP: What are some of the challenges researchers have faced in the past and currently in finding and recruiting Parkinson’s patients for studies?

CL: Clinical trial recruitment is a challenge across all diseases, and Parkinson’s disease is no exception. One common barrier to recruitment includes concerns around privacy and sharing of participant data. Across PPMI and all its programs, Evidation prioritizes user privacy and consent. For PPMI, we ensure that all data that is contributed is de-identified and shared only with qualified researchers who must apply and agree to protect data privacy. Participants’ information is never sold or shared outside the research community.

OSP: Do you have anything to add about the PPMI project, Evidation’s technology, etc.?

CL: Given the projected growth and impact of Parkinson’s disease, there is a need to rapidly expand the types of data collected and scale disease-specific research. Digital health tools are uniquely useful in better understanding neurodegenerative diseases, specifically Parkinson’s disease.  

We believe that electronic patient-reported outcomes and person-generated health data from active and passive collection methods, including wearables, show immense promise in characterizing the complex, longitudinal aspects of neurodegenerative diseases.

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