Observational studies harnessed from real-world data from clinical practice have valuable implications in decision-making and can answer clinically relevant questions with broad applicability. Clinical trial data, while valuable from a regulatory standpoint for approval of new medications, have more limited applications in the clinical setting. We are using our vast patient experience to better understand the effectiveness, safety, and patient experience with different treatment strategies in clinical practice. These studies leverage data from routine care that are not constrained by rigid clinical trial protocols and, thus, are more generalizable and applicable to healthcare providers and patients living with multiple sclerosis.
Our investigators have explored the safety, tolerability, and effectiveness of disease therapies; MRI stability as a treatment target; the long-term benefit early initiation of disease therapy; the influence of various comorbidities on MS disease activity; and disease therapy discontinuation. These observational studies have utilized the Epic electronic medical record and the Knowledge Program, a Cleveland Clinic-developed database used to electronically collect longitudinal patient- and clinician-reported outcomes. The studies employ propensity score and other methods to reduce the impact of confounding and certain biases inherent in observational studies, thereby approximating a randomized study design for determining treatment effect differences.
Through structured collection and analysis of clinical data, we are able to leverage real-world outcomes to answer clinically relevant questions and inform decision-making in routine practice.
Devon Conway, MD, MSc has a funded collaboration with Novartis to describe disease modifying therapy adherence and the transition from relapsing-remitting MS to secondary progressive MS in patients treated with fingolimod.
Le Hua, MD receives research support from the Eric and Sheila Samson Foundation.
Daniel Ontaneda, MD, MSc has completed a funded research project with Novartis examining the comparison on first line and second line use of fingolimod in clinical practice.
Daniel Ontaneda, MD, MSc has a funded research project with Genentech to examine the early tolerability and efficacy of ocrelizumab in clinical practice.
Early tolerability and safety of fingolimod in clinical practice J Neurol Sci 2012;323:167-72. D, Hara-Cleaver C, Rudick RA, Cohen J, Bermel R. PMID: 23040960.
Long term benefit of multiple sclerosis treatment: an investigation using a novel data collection technique. Conway DS, Miller DM, O’Brien RG, Cohen JA. Mult Scler J. 2012;18(11):1617-24. PMID: 22653659.
Comparative efficacy and discontinuation of dimethyl fumarate and fingolimod in clinical practice at 12-month follow-up. CM, Love, TE, Cohn, S, Hara-Cleaver, C, Bermel, RA, Fox, RJ, Cohen, JA, Ontaneda, D. Mult Scler Relat Disord. 2016;10:44-52. PMID: 27919497.
Lack of magnetic resonance imaging lesion activity as a treatment target in multiple sclerosis: an evaluation using electronically collected outcomes. Mult Scler Relat Disord. 2016;9:129-134.Conway DS, Thompson, NR, Cohen JA. PMID: 27645360.
Comparative efficacy and discontinuation of dimethyl fumarate and fingolimod in clinical practice at 24-month follow-up. CM, Love, TE, Bandyopadhyay, A, Cohn, S, Hara-Cleaver, C, Bermel, RA, Fox, RJ, Cohen, JA, Ontaneda, D. Mult Scler J Exp Transl Clin. 2017;3(3):2055217317715485. PMID: 28890796.
Influence of hypertension, diabetes, hyperlipidemia, and obstructive lung disease on multiple sclerosis disease course.Conway, DS, Thompson, NR, Cohen, JA. Mult Scler. 2017;23(2):277-285. PMID: 27230791.
Members & Collaborations
- Robert A. Bermel, MD
- Jeffrey A. Cohen, MD
- Devon Conway, MD, MSc
- Robert J. Fox, MD, MSc
- Claire Hara-Cleaver, BSN, MS
- Carrie M. Hersh, DO, MSc
- Le Hua, MD
- Marisa P. McGinley, DO
- Deborah M. Miller, MSW, PhD
- Brandon P. Moss, MD
- Daniel Ontaneda, MD, MSc
- Nicolas Thompson, MS
External Relationships and Collaborations
- Enrique Alvarez, MD PhD – University of Colorado
- Thomas E Love, PhD – Case Western Reserve University
- Brandi Vollmer – University of Colorado