There’s an often-quoted adage that if you want something done right, do it yourself. Unfortunately, in healthcare, that’s not a reality for most patients. Instead, those suffering from illness and disease must wait for researchers and clinicians to find and develop treatments and therapies that can provide a cure, treatment or relief.
But things are changing. iConquerMS is a ground-breaking initiative that empowers people with multiple sclerosis (MS) to help drive MS research and accelerate efforts toward improving treatments and finding a cure for the disease.
Patients fighting against a growing disease
MS is the most widespread disabling neurological condition of young adults around the world. It can be diagnosed at any age, but it is diagnosed in most people between the ages of 20 and 50. Nearly a million people in the U.S. are living with the disease, more than double the number reported in 1975. Additionally, there are about 200 new cases diagnosed each week. There is currently no cure for MS, but existing treatments can manage symptoms, lessen the frequency of relapses and slow the progression of the disease¹.
The story of empowering patients with MS began four years ago when the Accelerated Cure Project for Multiple Sclerosis (ACP) obtained funding from the Patient Centered Outcomes Research Institute (PCORI). ACP provides researchers with the resources to find ways to improve outcomes for people living with MS. It curates a repository that provides a uniquely valuable collection of thousands of datasets and bio samples as well as millions of data points that are available for the benefit of all researchers.
With its rich history of aggregating and data sharing, it’s no wonder that ACP used the funding to create iConquerMS, a people-powered research network of over 4,700 individuals with MS worldwide who contribute data, samples and expertise to drive research on topics they care about. This unique approach to research is led by people with the disease. The governance of the initiative, including a governing board, research committee, and engagement committee is made up of a majority of people with MS and has helped to shape and decide what the initiative should look like, the types of survey questions they should be asking and the way in which information is presented.
Data sharing and making data available is a significant topic of discussion in healthcare today and iConquerMS is opening new doors when it comes to making valuable data available to researchers. One of the unique features of the both the ACP Repository and the iConquerMS initiative that is furthering the goal of data sharing is its data return policy. The samples and data from the ACP Repository are available to any researcher with a sound research question with the requirement that all research results are returned to ACP for inclusion in the Repository database and for sharing with other researchers. To date, more than 100 research teams have accessed the Repository and over half have returned datasets back with more on the way. This data return policy has helped expand the ever-growing wealth of MS patient information gathered from researchers who have leveraged data from the Repository.
Driving patient empowerment
As healthcare turns to value-based care, there has been more of an emphasis on patients taking control of their own care – finding and evaluating providers when choosing medical services and being involved in care decisions. iConquerMS takes patient empowerment to another level.
The iConquerMS initiative is conducted through an on-line portal that allows people affected by MS to safely and securely provide personal health information through completion of surveys, set the research agenda for studies by submitting research questions of interest and connect and share experiences with other people in the MS community.
iConquer MS is one of 31 health data networks that form PCORnet: The National Patient-Centered Clinical Research Network, a new national resource that aims to boost the efficiency and effectiveness of health research through patient involvement. The goal is to reduce the time and effort needed to launch new studies and focus research on questions and outcomes especially useful to patients and those who care for them.
Incorporating patient input in drug development
The U. S. Food and Drug Administration (FDA) is helping to drive patient empowerment by preparing to incorporate new types of patient experience data and information into its benefit-risk framework for regulatory decision making. The initiative will provide biopharma companies the opportunity to demonstrate the impact of their therapies on outcomes that matter most to individuals with MS.
The FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making.
The FDA has been making significant efforts to advance the patient voice in medical product development and is encouraging drug developers to listen to patients to make the process more patient-centered. The FDA is accepting public comments on the PFDD guidance until December 2018².
ACP is already making strides in this area with its recent collaboration with EMD Serono to capture and integrate perspectives of people affected by MS into the design and implementation of clinical trials. The collaboration includes the development and validation of patient-reported outcomes in drug development.
Teams from EMD Serono and iConquer MS will be working together to develop the design and goals of future MS trials. In addition, iConquer MS participants will provide input across all stages of the study through workshops, document reviews, focus group and surveys³.
Patients have longed for a seat at the table when it comes to finding effective therapies to treat their disease. Patients providing data directly could be the key that opens the door and gets them invited into the process. ACP and iConquer MS is showing the world that including people affected by a disease can be a powerful way for them to contribute to the fight against their disease and may be setting the example for other disease research.
 Multiple Sclerosis: Facts, Statistics, and You, by Brandi Koskie, HealthLine June 20, 2018
 Statement from FDA Commissioner Scott Gottlieb, M. D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making, FDA Statement June 12, 2018
 EMD Serono, ACP Work Jointly, to Make MS Clinical Trials More Patient-Focused, by Janet Stewart, Multiple Sclerosis News Today, October 9, 2018