MDA in June announced the award of a clinical research network grant (CRNG) to Michael Benatar, M.D., Ph.D., at the University of Miami Miller School of Medicine in Florida, and Jonathan Katz, M.D., at California Pacific Medical Center in San Francisco, to support the Clinical Procedures To Support Research (CAPTURE) project, which aims to implement the “ALS Toolkit” within the Epic Electronic Health Record System. The ALS Toolkit provides a mechanism to systematize collection of clinical data so that it can also be used for research.
The two-year award totaling $300,000 will support work conducted through Clinical Research in ALS and Related Disorders for Therapy Development (CReATe) aimed at lessening the burden on people with ALS to attend both clinical and research appointments. CReATe, a rare disease clinical research consortium, is a member of the National Institutes of Health’s Rare Diseases Clinical Research Network. CReATe is funded through a partnership between the National Center for Advancing Translational Sciences (NCATS) and the National Institute of Neurological Disorders and Stroke (NINDS).
Clinical data will be used for research
Throughout the course of the disease, people with ALS require input and assistance from multiple health care professionals and, as a result, multidisciplinary clinics such as MDA ALS Care Centers serve as a key resource for ongoing medical management and care. Visits to care centers take several hours, and a substantial amount of clinical data (such as neurological examination results, quantification of respiratory muscle strength and motor function assessments) are routinely collected — much of it identical to the assessments performed at specialized research visits. However, data from these two types of visits are typically captured separately, necessitating separate appointments for people who, depending on the stage of their disease, may experience profound weakness, disability and difficulty associated with travel.
It has therefore been a longstanding goal of many ALS clinician-investigators to find ways to reduce the burden on patients by finding a way to regularly collect a standard data set at clinic appointments that can be used for research purposes as well.
With increasing penetration of the electronic medical record into academic medical centers, and the recently established collaboration between Benatar and Katz with Epic, a team will now develop and implement a novel ALS Toolkit (set of “smart forms”) within the electronic medical record system that will enable clinicians to collect standardized data that can serve both clinical and research purposes.
“MDA is excited to support this effort to integrate research data collection into the standard visits patients have with their physicians — making it easier for people with ALS to participate in research,” said MDA Scientific Program Officer Amanda M. Haidet-Phillips, Ph.D. “The work being done by Drs. Benatar and Katz seeks to reduce the barriers that prevent some people with ALS from participating in research, and will make it easier for doctors to collect information that can be used for research purposes to gain a better understanding of ALS and its subtypes, develop biomarkers and accelerate therapy development. The hope is that making it easier for both patients and doctors to participate in research will increase involvement and speed progress.”
A fundamental change in practice
The project involves completion of the development of the ALS Toolkit in partnership with Epic, after which it will be piloted at the University of Miami and California Pacific Medical Center. Approximately 100 people with ALS will be enrolled for the testing phase of the toolkit at the two sites.
“The clinic is the most important venue for regularly seeing and evaluating ALS patients. In addition, valuable data is routinely collected and entered into electronic health records at every appointment, at every ALS Center across the country,” Benatar explained. “To date, no one has taken the steps to structure this regular flow of data, or to combine them in a single database. Instead, we have costly research protocols that collect the same information, requiring an ongoing duplication of work, while attempts to transfer clinically collected data into a research database requires extra steps of duplicating data entry — once into the medical record and once into a research database.”
The new system represents an opportunity to fundamentally change practice, and is expected to increase efficiency and reduce costs.
“Integration of a mechanism to collect research-useful data through a clinical workflow within the electronic health record offers a huge opportunity not just to increase efficiency, but to transform the power of clinically collected data to support the engine of research,” Katz said.
Researchers will be empowered to use clinical data for research purposes, and clinicians who currently are working in isolation in single centers will be able to take part in a wider research community.
MDA continues to lead the fight against ALS
MDA has dedicated more than $363 million to ALS research and support services since 1950. Including five ALS research grants announced in March, and the recent award to Benatar, MDA currently is funding 44 active ALS grants with a total funding commitment of $11.4 million. This year, MDA is funding 150 different research projects around the world.
