MJFF Suggests Ways to Help Advance Clinical Trials During Pandemic

online research tools

With numerous clinical trials interrupted due to the COVID-19 pandemic, The Michael J. Fox Foundation (MJFF) is highlighting online ways that Parkinson’s (PD) patients and others can help to advance research.

People are necessarily spending more time at home, but study participation remains crucial to treatment development. Even before the outbreak, volunteer shortages delayed 85 percent of clinical trials. Thirty percent were unable to even get started.

“It can be an empowering and impactful opportunity for people with and without Parkinson’s disease to help accelerate breakthroughs in treatment,” the MJFF states on its webpage about research participation. “You have the power to help researchers understand how Parkinson’s starts and progresses.”

One research opportunity is the organization’s Fox Trial Finder, an online tool that matches individuals with studies for which they may be eligible. Even if the trial is on hold, patients and others can still express interest. Study coordinators will follow up once recruitment restarts.

Trials can be found through a guided search, or, based on location and keyword, by independent searches. Those interested may also register to receive email alerts about local studies that are or will be recruiting.

Another way to get involved is by joining the organization’s Fox Insight, a digital platform and clinical study aimed at building a large cohort of patients and age-matched control volunteers to help focus treatment priorities, inform their development, and optimize trial design.

This long-term study, which includes patients, families, and caregivers, collects de-identified self-reported data about health experiences. Through an associated genetic sub-study, powered by consumer genetics company 23andMe, eligible individuals can help researchers gain a holistic view of Parkinson’s.

“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,” MJFF states about Fox Insight, which opened in 2017.

Go here to register and for an informational video.

Elsewhere, the University of Rochester’s neurology department is offering a 20-minute survey that aims to help scientists learn more about Parkinson’s symptoms and everyday issues of importance to patients. The anonymous responses will be used to guide additional studies and to help develop a disease-specific patient-reported outcome measure for clinical trials. The survey may be completed online, on paper, or over the phone.

Bastyr University, in California and Washington state, is leading an online study about complementary and alternative medical care in Parkinson’s. It aims to help scientists learn more about diet, lifestyle and Parkinson’s progression, and the long-term effect of complementary and integrative care on health and life quality.

Patients are asked to complete two online questionnaires every six months for five years. Survey topics cover diagnosis, disease status, sense of balance, daytime sleepiness, walking, dressing, eating, falling, speech, handwriting, pain, vision, sense of smell, comprehension and cognition, sexual dysfunction, dyskinesia, and posture.

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During COVID-19 Outbreak, MJFF Creates Information and Resource Hub

COVID-19 and Parkinson's

To support the global Parkinson’s disease community during the COVID-19 pandemic, The Michael J. Fox Foundation (MJFF) is spotlighting its new information and resource hub.

The dedicated site includes webinarspodcasts, online educational events, insights and tips regarding PD and the coronavirus, and a virtual events hub to see how the community is staying connected.

“COVID-19 is testing us all in ways we never imagined,” said Michael J. Foxactor and MJFF founder, in a video accompanying the announcement. “Around the globe, individuals, families, and nations are rising to this challenge with courage and grace. “…Together we will pull through this, and be stronger than ever.”

Today (April 29) at noon EDT, the organization will present a 30-minute webinar about how to participate in Fox Insight, the MJFF’s online clinical study aimed at providing the research community with critical insight into the experience, genetics, and variability of Parkinson’s. (Register here.)

Recent webinars are now available on demand and via podcast. In one, panelists discuss how the Parkinson’s care and research community is responding to COVID-19, as well as actions patients and caregivers can take during the pandemic. In another, experts discuss strategies — including mindfulness and meditation — for coping with Parkinson’s during this uncertain time.

The hub also features educational events from the MJFF’s Parkinson’s IQ + You sessions, which have been moved online. In collaboration with the Parkinson’s Disease Education Consortium, an on-demand presentation discusses telemedicine and how it can work for Parkinson’s patients. The event also features a conversation with a patient and care partner about optimizing virtual doctor visits.

In the MJFF’s “Ask the MD” program, Rachel Dolhun, MD and vice president of MJFF medical communications, offers practical tips and insights on COVID-19 and Parkinson’s disease. Topics include “Coronavirus and Parkinson’s,” “Staying Active,” “Easing Mood Changes and Isolation,” Living with Parkinson’s Amid the Coronavirus Pandemic,” “Smell Loss in Coronavirus and Parkinson’s Disease,” “What We Know and Don’t Yet Know,” and “Making the Most of Your Telemedicine Doctor Visit.”

For more information and updates on managing your health during this unprecedented period, you can follow the MJFF on Facebook, Instagram and Twitter. Patients and caregivers are invited to share across those sites how they are coping. Responses could be featured in the #TogetherAtHome global campaign that seeks to encourage a united pandemic front.

Because many institutions are prioritizing the public health crisis, many foundation grantees are feeling the pinch. That motivated the MJFF to establish for scientists FAQs: Coronavirus (COVID-19) & Research Support. The site is for current grantees and applicants, and answers questions related to COVID-19.

“Our commitment to these researchers, and to you, is to keep critical Parkinson’s research moving forward with as little disruption as possible by being flexible and responsive to their needs as the situation evolves,” the foundation stated. “Our staff continues to work with urgency and determination to move our programs forward.”

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FIRE-UP PD Initiative Seeks to Increase Inclusivity in Parkinson’s Research


The Michael J. Fox Foundation (MJFF) and Massachusetts General Hospital have announced an initiative to enhance diversity in Parkinson’s disease research.

Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson’s Disease (FIRE-UP PD) is an MJFF-funded study that will establish and assess outreach programs in Boston, Massachusetts, Weston, Florida, Denver, Colorado, and Chicago, Illinois. Massachusetts General’s Community Access, Recruitment and Engagement (CARE) Research Center is coordinating the effort.

“Parkinson’s research has made significant strides toward better diagnostics and new treatments in past decades, but most research has included only a subset of patients with a common European ancestry,” said Sohini Chowdhury, MJFF deputy CEO, in a press release.

“Imagine where we would be with a more holistic view of the disease. This program aims to broaden the vital partnership between researchers and the people living with Parkinson’s, each and every one,” Chowdhury said.

Jonathan Jackson, the CARE Research Center’s founding director and FIRE-UP PD principal investigator, said that because PD is such a varied disease and affects each person differently, both in terms of symptoms and disease progression, research inclusivity is key.

“When we include people from all backgrounds in Parkinson’s research, we better understand the disease itself, improving our chances at finding treatments that work for everyone. FIRE-UP PD is unique in its attention to diversity in Parkinson’s research and its application of community-based methods across all geographic regions,” he said.

Four academic centers will develop community-centered interventions to produce culturally sensitive messaging and resources that educate and engage around Parkinson’s research. The sites and programs include:

Boston Medical Center: Researchers will partner with community health centers to engage Boston’s Haitian and African American communities by using educational tools emphasizing the importance of Parkinson’s research  and diagnosis.

Cleveland Clinic in Weston, Florida: The focus at this site is southern Florida’s Hispanic communities, and engagement through educational seminars and collaboration with area support groups.

University of Colorado: Through a method called Boot Camp Translation, which recruits healthcare professionals and community members to translate medical information for local populations, investigators will address health literacy in Hispanic and lower-income populations.

Northwestern University, Chicago: A stakeholder partnership of patients, community leaders, caregivers and physicians will conduct focus groups and create community-specific educational toolkits for Hispanic, African American and lower-income residents.

In addition to enhancing disease awareness and fostering trust in Parkinson’s  research participation, the programs hope to promote enrollment in MJFF’s Fox Insight, an online clinical study aimed at building a large, diverse group  of Parkinson’s patients and age-matched control volunteers to gain insight into the disease’s experience, genetics and variability.

To that end, sites in Minneapolis, Minnesota, San Francisco, California, Chicago and Kirkland, Washington will offer Fox Insight materials exclusively in their clinics in order to compare conventional outreach methods with those of the intervention sites.

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Fox Foundation and 23andMe Launch Data Platform Fox DEN to Help Accelerate Research Efforts

patient data, Parkinson's

The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and 23andMe announced the launch of a data and analytics resource for researchers, based on patient experiences, that aims to improve clinical trial design and, subsequently, therapies for Parkinson’s.

Called the Fox Insight Data Exploration Network (Fox DEN), it’s the platform for Fox Insight, an online, MJFF-sponsored clinical study about health-related experiences from volunteers with and without Parkinson’s disease. Fox DEN features patient-reported outcomes, de-identified (for privacy) genetic data, and information exploration tools from what’s known as the most expansive cohort in Parkinson’s investigations.

“Parkinson’s is an extremely variable disease that affects individual patients in unique ways,” said Todd Sherer, PhD, MJFF’s chief executive officer, in a news release. “This complicates drug development and clinical trial design. Fox DEN addresses this by bringing the patient experience to researchers at an unprecedented scale and amplifying the patient voice in the development of new therapies for Parkinson’s.”

Developed by the Laboratory of Neuro Imaging at the University of Southern California, the resource features health and disease survey results, patients’ daily activities, and other information pertinent to Parkinson’s research. It also includes genetic data from 23andMe customers participating in the Fox Insight study. So far, some 35,000 individuals have contributed, with tens of thousands more expected.

The data can be used to enhance disease understanding, and help with clinical trial recruitment and segmentation. Subject co-horts can be created using specific characteristics such as cognitive symptoms, genetic mutations, or environmental exposures. Ultimately, the hope is that research timelines can be shortened, and new treatments are brought to market faster.

“Accelerating research is core to our mission, and making this data available to qualified researchers will do just that,” said Paul Cannon, PhD, disease program manager for 23andMe, a leading genetics and research company. “Fox DEN will facilitate access to, and exploration of, this important information, increasing the pace of Parkinson’s research and opening up new study opportunities.”

Fox Insight is invaluable in that it is collecting vast amounts of disparate data on the real-world experiences of Parkinson’s patients, said David G. Standaert, MD, PhD, chair of the University of Alabama at Birmingham’s neurology department.

“Fox DEN is the window through which we can study this data and gain important new insights into the causes, consequences and treatment of Parkinson’s,” he added.

Interested investigators globally may register here.

23andMe is a private company specializing in DNA analysis and “ancestry services.”

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Feedback from Parkinson’s Patients Can Help Improve Trial Recruitment, Retention, Study Says

clinical trial feedback

Getting the perspective of Parkinson’s disease patients on their motivations and experiences participating in clinical trials can help increase recruitment and retention of future studies, a report suggests.

Although preventable, one of the most common reasons Phase 2 or 3 trials fail is because not enough patients participate. This could be due to inadequate recruitment or because patients drop out during the trial.

The report, “Recruitment and Retention in Clinical Trials of Deep Brain Stimulation in Early-Stage Parkinson’s Disease: Past Experiences and Future Considerations,” published in the Journal of Parkinson’s Diseaseevaluated patient responses after a pilot study on the safety and tolerability of subthalamic (STN) deep brain stimulation (DBS) for the treatment of early-stage Parkinson’s disease.

DBS is commonly used to treat patients with advanced Parkinson’s who no longer respond to available medications and are unable to adequately manage their symptoms.

The U.S. Food and Drug Administration also recently expanded the use of DBS — which requires surgery to implant a device to stimulate targeted regions of the brain — to patients with mid-stage disease who also respond poorly to standard medications.

Vanderbilt University in Nashville, Tennessee, completed a clinical trial (NCT00282152) that included 30 patients, ages 50 to 75, with early-stage Parkinson’s disease. The participants were randomized to receive either optimal drug therapy (ODT) or ODT plus STN-DBS and followed for two years.

At the end of this pilot study, participants were asked to complete a survey regarding their experiences participating in the trial. Their responses were compared with those from an independent survey that used Fox Insight, an online clinical study platform established by The Michael J. Fox Foundation for Parkinson’s Research, to survey early-stage Parkinson’s patients who were considering possibly participating in a trial for DBS.

The pilot trial was specifically designed to collect preliminary safety and tolerability data necessary to conduct an FDA-approved Phase 3 trial (IDE#G050016) to investigate the hypothesis that DBS in patients with early Parkinson’s can slow disease progression.

Importantly, patient experiences were expected to inform the feasibility of scaling up recruitment for the future trial.

Results revealed that the primary motivation for participating in a clinical trial was the desire to advance medical research, cited by 85% of trial respondents. This was followed by a desire for the best medical treatment, for 70%, and for 59%, a desire to learn more about Parkinson’s disease. Similarly, altruistic motivations were also seen in the Fox Insight survey.

The most frequently listed fear that could impact trial participation was surgery-related concerns, in 44% of participants. Although 37% of the pilot study participants did not report any burdens, the most common burdens associated with clinical trials were financial commitments such as time off work and traveling costs (30%), as well as some of the therapeutic interventions such as neuropsychological testing (26%), and the weeklong therapeutic washout periods — without medication (26%).

The pilot study implemented a rigorous informed consent progress aimed at educating potential participants on their role in the study. Most participants responded positively to this approach. Providing sufficient education at the start of the trial may decrease the drop-out rate. In fact, only 3% of participants did not complete the study. As a result, this approach of informed consent will be used in the upcoming Phase 3 trial, according to the authors.

Getting patient perspectives is a new strategy that could improve clinical trial recruitment and retention. Whereas most clinical trials were solely designed by physicians, now, as the authors suggest, by asking patients about their experiences and including their feedback in trial development, “the focus shifts away from the physician and toward the patient.”

“By understanding the motivations and barriers to trial participation of past and potential subjects, we attempt to predict feasibility of recruitment in the future pivotal trial,” the authors wrote. “The fundamental similarities of these two cohorts of patients with early-stage [Parkinson’s disease] suggest that the planned multicenter, pivotal trial will experience similarly successful recruitment and retention as the single-center pilot trial.”

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Source: Parkinson's News Today

Michael J. Fox Foundation Offers Educational Tool to Boost Participation in Parkinson’s Clinical Studies

clinical trials

The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has launched an educational suite called “Parkinson’s Clinical Trial Companion” to increase patients’ participation in clinical trials.

The new resource educates patients and families about the benefits of participating in research, and provides teams conducting clinical trials with high-quality tools to recruit and retain volunteers.

Lack of volunteers greatly limits clinical research, causing 85 percent of trials to face delays and 30 percent to never begin. Results from a 2014 survey of more than 1,500 Parkinson’s patients, caregivers and physicians showed that 81 percent of patients who see a movement disorder specialist would be likely or very likely to participate in a trial if there was one in their area.

“Patient participation in research is key to driving scientific breakthroughs and cures. Yet clinical trials routinely encounter roadblocks that slow progress, including a chronic shortage of volunteers,” Todd Sherer, PhD, CEO at MJFF, said in a press release.

“We believe it is our obligation to foster partnerships among patients, families and researchers to bring more people with the disease into Parkinson’s clinical trials by educating potential study participants and supporting trial teams’ recruitment efforts,” he added.

MJFF’s Parkinson’s Clinical Trial Companion is designed to holistically address challenges in clinical trial recruitment. The suite is partly educational for those with Parkinson’s disease and partly a resource for clinical trial teams, and is composed of two packs.

In the “Trial Participant Pack patients and families will have a 52-page guide called “Navigating Clinical Trials” to explain diverse aspects of clinical research, including trials’ phases, informed consent processes, genetic testing, studies on every disease stage, international research opportunities, as well as the role of family and caregivers to support participation.

The guide will be available in Spanish, French, German and Italian to serve as a global resource. It also contains personal stories and videos featuring patients, care partners and clinical trials’ scientists.

In the “Trial Resource Pack” research teams can find a best practices manual, which centers on participant experience to optimize clinical trial design. The manual builds on new technologies that recently have showed success in increasing patient awareness and willingness to participate in clinical trials, while also facilitating data collection.

The guide also has a downloadable toolkit containing 34 templates that can be customized to better present a study to the Parkinson’s community and successfully recruit and retain patients.

Connecting participants

“The task of recruiting and retaining study participants need not be overwhelming,” said Tanya Simuni, MD, chief of Movement Disorders in the Department of Neurology at Northwestern University Feinberg School of Medicine.

“Parkinson’s Clinical Trial Companion offers trial teams a step-by-step, patient-centered approach to support progress in Parkinson’s research through practical resources designed to help streamline participant enrollment and ensure that volunteers continue through to the trial’s end,” she said.

The tool adds to MJFF’s online platform Fox Trial Finder, launched in 2012, which connects Parkinson’s patients and other potential volunteers with clinical studies in their area, to ultimately boost trial enrollment process and increase patients’ involvement in the discovery of new treatments.

MJFF often hosts and participates in clinical trial fairs and other Parkinson’s events across the U.S. The foundation also is the sponsor of the online clinical study Fox Insight, and the Parkinson’s Progression Markers Initiative, which aims to spot and validate biomarkers of the disease.

The new resource was funded by Acadia Pharmaceuticals, Adamas Pharmaceuticals, Cellular Dynamics International, Lundbeck, Pfizer, Prothena and Sunovion Pharmaceuticals, all members of MJFF’s 2017 Parkinson’s Disease Education Consortium.

“I am grateful to the researchers, neurologists and everyone in the Parkinson’s community for their contributions and dedication to the pursuit of a cure,” said Steve DeWitte, a member of the foundation’s Patient Council. “But there’s one thing patients must do ourselves: participate in clinical trials. By making the decision to get involved in research, we can help overcome a major roadblock on the path to a cure.”

As part of its ongoing mission to help find new therapies for Parkinson’s, MJFF recently announced a new $7 million funding program to support research and speed development of new therapeutic targets and biomarkers. Pre-proposals will be accepted through May. Funding is anticipated by November 2018.

Among the areas covered by the new funding are nonpharmacological interventions for gait and balance impairments, projects on brain circuitry and clinical experience of gait and balance problems, and research on the protein alpha-synuclein, the major component of Parkinson’s hallmark protein clumps, called Lewy bodies.

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Source: Parkinson's News Today