Mary Jane "MJ" Mulcahey, PhD, OTR/L, CPPC, CLCP, FASIA, on Reevaluating Outcome Measures for Spinal Cord Injury Clinical Trials
The director of the Center for Outcomes and Measurement in the Jefferson College of Rehabilitation Sciences at Thomas Jefferson University discussed the research she presented at the first Annual SCI Investor Symposium.
“The main implication of the research around outcome measures is that healthcare providers really need to understand some of the limitations of the outcome measures so that when they interpret outcomes of care or outcomes of studies their interpretation is in light of the limitations. [We need to be] very careful in making sure that we don't overstate our outcomes or understate our outcomes.”
Significant unmet need remains for patients with spinal cord injuries (SCIs), and as such many companies and institutions are currently engaged in research and development for novel treatments. Among these investigational treatments are cell therapies, including Lineage Cell Therapeutics’ OPC1. Other forms of treatment, such as epidural stimulation and functional electrical stimulation, are also being investigated by some institutions.
Recently, experts in the SCI treatment space gathered at the first Annual SCI Investor Symposium, held on June 29, 2023, in San Diego, California, to share their findings and foster cooperation in research. One important topic discussed at the meeting was the utility of the efficacy outcome measures being used in clinical trials for these novel treatments. Mary Jane "MJ" Mulcahey, PhD, OTR/L, CPPC, CLCP, FASIA, the director of the Center for Outcomes and Measurement in the Jefferson College of Rehabilitation Sciences at Thomas Jefferson University, gave a talk at the symposium about her research on this issue.
In an interview with CGTLive™, Mulcahey went over the key findings she presented regarding measurement of clinical efficacy in SCI clinical trials for therapeutics that target the central nervous system and the main implications of her work. She noted that the limitations of outcome measures currently being used may affect the accuracy of clinical trial findings. Mulcahey also highlighted the potential of using imaging biomarkers to evaluate efficacy, mentioned the challenge of measuring impact of therapeutics on quality of life, and emphasized the importance of outcome measure selection and interpretation.
