New patient registry aims to collect real world evidence on MG in US
MGFA teams up with Vitaccess to build long-term data tracking platform
Written by |
- The MGFA is teaming up with Vitaccess on its launch of a new patient registry to collect real-world data on myasthenia gravis.
- The registry will use medical records and patient surveys to improve MG clinical trials and patient care.
- A webinar will be held on Feb. 20 to offer step-by-step instructions for participating in the registry.
Aiming to address a persistent gap in myasthenia gravis (MG) research, Vitaccess is teaming up with the Myasthenia Gravis Foundation of America (MGFA) to expand real-world data collection in MG.
As part of the new exclusive agreement, MGFA will become the official collaborator for the Vitaccess Real MG (VRMG) registry, a patient-centered platform designed to generate comprehensive, real-time evidence on the rare autoimmune disease. The goal of the new registry is to better inform clinical trials and, ultimately, improve patient care for those living with MG, according to a company press release announcing the partnership.
“There’s a gap between what clinical trials can show and what decision-makers need to see,” said Mark Larkin, PhD, Vitaccess’s CEO and founder. “This is particularly evident in a disease like MG.”
The MGFA and Vitaccess will host a webinar on Feb. 20 to provide both an overview of the VRMG registry and a step‑by‑step guide for participating. Anyone interested in taking part is invited to join in the virtual event or access the company’s website for more information.
Vitaccess noted that, while clinical trials can demonstrate whether a therapy is effective under controlled conditions, such studies often fail to capture the long-term, day-to-day experiences of patients. According to the company, that is data that are increasingly sought by regulatory agencies, payers, and organizations involved in reimbursement and policy decisions.
A rare, chronic neuromuscular disease, MG is marked by fluctuating muscle weakness and fatigue. Symptoms often begin in the eyes, face, or throat — causing drooping eyelids, double vision, and difficulty speaking or swallowing — but can also affect the arms, legs, and breathing muscles.
Wide range of symptoms in MG underscores need for patient registry
The condition varies widely from person to person, with disease severity and symptoms influenced by underlying causes and MG subtypes. According to Vitaccess, that underscores the need for robust, long-term real-world evidence about MG.
Larkin noted that the U.K.-based company has conducted patient-centered research in MG over the past seven years, working closely with advocacy groups.
“This partnership with MGFA is exciting — we are combining their years of patient trust with our scientific expertise and technology-enabled patient engagement infrastructure, creating sustained patient relationships that compound in value over time,” Larkin said. “Together we will build evidence that we believe will ultimately improve outcomes for patients and caregivers living with MG.”
As part of the collaboration, MGFA will introduce its large patient and physician community, including existing members of its own, older registry, to the VRMG platform. More than a decade of registry data will also be integrated into a secure, confidential repository, creating a resource for analyzing previously acquired clinical data.
Together we will build evidence that we believe will ultimately improve outcomes for patients and caregivers living with MG.
The VRMG registry, expected to last a decade, will combine individuals’ medical records and patient-reported outcomes to evaluate symptom patterns, treatment effectiveness, and quality of life over time in real-world settings.
Medical records will be provided by the treating healthcare professional or captured by an electronic medical record aggregator, while patient-reported outcomes will be assessed through monthly surveys that will take about 15 minutes to complete. Participants can drop out at any time, the company noted.
The goal is to produce decision-grade data that can support regulatory submissions, market access strategies, and commercial planning — ultimately helping bring new therapies to patients more quickly.
Participants can access VRMG registry via smartphone or computer
Participants must be 18 or older and live in the U.S. The VRMG registry and associated surveys can be accessed from any connected device, such as smartphones, tablets, or computers. Those taking part will also receive vouchers for every completed survey.
Those currently participating in a clinical study can only enroll in the registry after the trial’s completion.
MGFA will hold a seat on the VRMG scientific advisory board, giving patients and clinicians a voice in shaping the registry’s priorities. The partnership is also expected to expand opportunities for investigator-led research, with MGFA continuing to offer grants to fund studies using MG datasets.
In addition, the expanded registry infrastructure is designed to improve clinical trial recruitment by enabling researchers to identify and engage eligible participants more efficiently.
“Our community has always understood the value of contributing to research that can improve the quality of life for individuals living with MG,” said Samantha Masterson, president and CEO of MGFA. “This partnership ensures that those powerful patient contributions influence groundbreaking discoveries and potential new treatments.”
Masterson added that Vitaccess’s scientific rigor and ability to generate regulatory-grade evidence across the drug development process — from Phase 1 trials through post-marketing — made it the right partner.
“The data our members have shared over the past decade will now inform a new wave of evidence and holds immense potential to help researchers, clinicians, and pharmaceutical companies understand MG in ways that were not possible in the past,” Masterson said.
During the upcoming webinar, to be held this Friday from 2 p.m. to 3 p.m. ET, MGFA and Vitaccess will review the platform and offer guidance for how patients and healthcare professionals can participate in the VRMG registry.
Vitaccess stated: “We look forward to sharing more details … and encourage all interested members of the MG community to join us and learn how they can contribute to this important initiative.”
Leave a comment
Fill in the required fields to post. Your email address will not be published.