Abstract Details

Title Updates to the National Institute of Neurological Disorders and Stroke (NINDS) Multiple Sclerosis (MS) Common Data Element (CDE) Recommendations: 2018 MS Oversight Committee (OC) Review

Topic Multiple Sclerosis

Presentation(s) P4 - Poster Session 4 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-087

Objective The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) project was established in 2006 to develop data standards for clinical research in neuroscience. The goals of the NINDS CDE project include reducing study start-up time and cost, streamlining data collection, facilitating data sharing, improving data quality and serving as a resource for new clinical investigators.

Background The Multiple Sclerosis (MS) CDEs were developed in 2011 by a subject matter expert Working Group. These recommendations include template case report forms, CDE details and instruments. Recommendations are stratified by Classifications: Core (required), Supplemental-Highly Recommended (strongly encouraged based on study type), Supplemental (commonly collected, but not required), Exploratory (reasonable to fill in gaps, but require further validation). An MS Oversight Committee (OC) was formed in 2013 to review user feedback and updates to the CDEs based on advancements in clinical research. The OC convened most recently in 2018 to review the recommendations.

Design/Methods The MS OC members volunteered to review the existing MS CDE recommendations by subdomain. They focused on the following questions: Is the classification for the element/measure still accurate? Are there any new elements/measures that should be considered as Core or Supplemental-Highly Recommended? For instruments classified as Supplemental-Highly Recommended, can a context (e.g., for MS imaging studies) for use be specified?

Results The MS OC will reconvene to review the recommended updates prior to a public review on the NINDS CDE website. Changes to the MS CDEs will be incorporated and finalized once the OC has arrived at a consensus.

Conclusions NINDS encourages the use of CDEs for all clinical research in neuroscience. To ensure that the CDEs are a dynamic and useful resource, the recommendations are updated periodically based on the current state of science and user input.

Authors/Disclosures
Katelyn E. Gay (The Emmes Company, LLC) PRESENTER	Ms. Gay has received personal compensation for serving as an employee of The Emmes Company, LLC.
	No disclosure on file
Muniza Sheikh (The Emmes Company, LLC)	Ms. Sheikh has received personal compensation for serving as an employee of The Emmes Company.
Joy R. Esterlitz (The Emmes Corp)	No disclosure on file
Fred D. Lublin, MD, FAAN (Icahn School of Medicine At Mount Sinai)	Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche/Genentech. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurogene. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medimmune/Viela Bio/Horizon. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Receptos/Celgene/BMS. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Labcorp. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neuralight. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Entelexo. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avotres. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Lublin has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Multiple entities. Dr. Lublin has stock in Avotres. Dr. Lublin has stock in Neuralight. The institution of Dr. Lublin has received research support from Brainstorm. The institution of Dr. Lublin has received research support from biogen. The institution of Dr. Lublin has received research support from NIH.
Ursula Utz	Ursula Utz has nothing to disclose.
Codrin I. Lungu, MD, FAAN	Dr. Lungu has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier, inc..
	No disclosure on file

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