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CMSC Question of the Day: Harnessing iTechnology to Track Patient-Reported Outcomes

Learn how Richard Rudick, MD, and others envision iTechnology transforming MS patient care and research in the years immediately ahead – in this issue of the CMSC Daily Digest.
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CMSC Happenings
Thursday, May 29

Robert P. Lisak, MD, FAAN, FRCP (left), of the Foundation of the Consortium of Multiple Sclerosis Centers (FCMSC), reviews the research of one of the Foundation of the Consortium of Multiple Sclerosis Centers' Young Scholars honored yesterday.


Kottil Rammohan, MD, outlines plans for the North American Registry for Care and Research in Multiple Sclerosis (NARCRMS), a CMSC-administered, open-access longitudinal database that he predicted will help transform MS care in the years ahead. (See related article in this issue.)


Clay Walker and his band got the crowd rocking during last night's concert at the 2014 Cooperative Meeting of CMSC and ACTRIMS.

CMSC Daily Digest

FRIDAY, MAY 30, 2014

CMSC’s Nascent Longitudinal Database
To Transform MS Care in Years Ahead

Kottil Rammohan, MD

Kottil Rammohan, MD

A CMSC-administered database now in its developmental stages will provide clinicians, patients, researchers, and drug developers with real-world, longitudinal data to guide their decision-making, thus transforming all aspects of multiple sclerosis (MS) care, Kottil Rammohan, MD, said in the keynote lecture that opened Thursday’s session of the 2014 Cooperative Meeting of CMSC and ACTRIMS in Dallas, TX.

“I really think this is going to be huge in [terms of] our understanding of this disorder,” Dr. Rammohan told hundreds of health-care professionals and others gathered for his lecture. Predicting that the database had the potential to become “the Google of MS,” he added that the information platform “will provide information in real-time about what is happening in MS in this country from coast to coast.” Dr. Rammohan, who is Professor of Clinical Neurology, Director of the MS Center of Excellence, and Chief of the Multiple Sclerosis Division at the University of Miami’s Miller School of Medicine, explained, “We will amass a vast amount of information, and that will really change the way we think when we see an individual patient.”

The database will be known as the North American Registry for Care and Research in Multiple Sclerosis, or NARCRMS, and will operate in parallel with the North American Research Committee on Multiple Sclerosis, or NARCOMS, the global patient registry also administered by CMSC, Dr. Rammohan explained. He added that patients wishing to access NARCRMS data will need to be registered with and enter the database via NARCOMS.

An open-access platform
Open access is a key feature of the database, Dr. Rammohan noted, explaining that patients, clinicians, pharmaceutical companies, and potentially payers would have access to the de-identified information it contains. That data will be entered by clinicians at member centers of the Consortium of Multiple Sclerosis Centers and, eventually, by other clinicians who are trained in and agree to follow the database’s informed consent, privacy-protection and other protocols. Clinicians will be compensated for the time they spend entering data in accord with a fee structure based on National Institutes of Health (NIH) guidelines, said Dr. Rammohan, adding that all data entry will be via REDCAP, or the Research Electronic Data Capture paper-less platform used by many health-care registries and databases.

“We will amass a vast amount of information, and that will really change the way we think when we see an individual patient,” Kottil Rammohan, MD

The NARCRMS initiative will be guided by an 11-member Steering Committee led by Stephen L. Hauser, MD, of the University of California, San Francisco (UCSF) School of Medicine, Dr. Rammohan said. He added that there also will be a pharmaceutical industry advisory board, and input from executives and leaders of the CMSC, NARCOMS, and National Multiple Sclerosis Society (NMMS). Plans also are under way, he noted, to involve advisors from the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS) and private payers. Social and Scientific Systems, Inc., a company that has created databases in HIV, breast cancer, and other disease states, will handle technical design and operation of the database. In an interview prior to his lecture, Dr. Rammohan said he hoped the database would be online in 2015. Once online, it will be updated once daily to provide real-time information.

The neurologist said that NARCRMS will develop a standardized approach to information that all participating clinicians will be asked to collect and report at a patient’s annual visit, and that the data will include demographic, clinical, imaging, and biomarker findings. He added that, ideally, clinicians also would enter information from routine visits occurring throughout the year. There then will be 10 “cores” within NARCRMS focused on issues such as neuroimaging, genetics, biostatistics, and other components of investigating MS disease course and treatment. With the ability to define what information you want to access within one or more of those cores, “You will be able to do simple studies yourself or you can join with others to conduct larger studies,” Dr. Rammohan said of the research opportunities open to participating clinicians.

The impetus for the initiative
Dr. Rammohan explained that he and others first discussed creating such a database 15 years ago, when he chaired a patient-care committee for NMSS, but that the logistical and funding challenges precluded proceeding at that time.

Last year, he explained, executives at Novartis Pharmaceuticals invited him to discuss ideas for an open-access database, and those discussions paved the way for NARCRMS. Dr. Rammohan noted that Novartis has made a 5-year funding commitment to the project, while Biogen Idec, Roche/Genentech, and Teva Pharmaceutical Industries also are providing financial support. Dr. Rammohan said in an earlier interview that he hopes and expects that other pharmaceutical companies also will help fund the initiative.

“They need to hear us, and we need to hear them,” he said of pharmaceutical companies and clinicians in his lecture. He explained that the database will provide drug developers with critical insights into the optimal design and patient populations of future trials and can yield valuable information for Phase IV studies.

In his pre-lecture interview, Dr. Rammohan added that the database also offers many benefits to people living with MS. “A patient will be able to access the database and obtain information on the health status of others of the same age and gender who have been diagnosed with MS for approximately the same number of years. If a patient finds that he is not faring as well as his peers in a certain respect, this knowledge can provide powerful motivation to focus on that aspect of his health and to work with his physicians to pursue improvement.” In his lecture, Dr. Rammohan noted that special efforts will be made to obtain data on patients from minority groups and those from all socioeconomic strata.

Dr. Rammohan said that clinicians will find particular benefit in being able to monitor data on the long-term efficacy and tolerability of various therapies in patient populations beyond those studied in the agents’ pivotal trials. In his interview, he explained, “Clinical trials are – inevitably and with good reason – conducted in a somewhat contrived environment. Rigorous constructs must be employed to obtain statistically reliable findings. The timeframe cannot be open-ended. And safety and ethical considerations can require very stringent inclusion and exclusion criteria. As a result, front-line practitioners frequently lament that the people studied in trials bear little resemblance to the patients they see every day, limiting the value of trial data in their clinical decision-making. Now, for example, this real-world database will enable clinicians to assess the ongoing performance of a drug in an MS patient with a co-morbidity that may have been an exclusion criterion in that agent’s pivotal trial.”

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