AI Article Synopsis
- Randomized controlled trials (RCTs) are vital for getting approval for disease-modifying therapies (DMTs), but their restrictive criteria can limit who is included, affecting how generalizable the results are.* -
- Observational studies that use real-world data (RWD) can include a broader range of patients, making their findings more applicable to everyday treatment practices.* -
- Although observational studies have biases and limitations, using advanced statistical methods can help reduce these issues, and personalizing treatment approaches can enhance care for multiple sclerosis (MS) patients.*
Article Abstract
Randomized controlled trials (RCTs) are essential for regulatory approval of disease-modifying therapies (DMTs), yet their strict selection criteria often lead to limited generalizability. Observational studies using real-world data (RWD) allow for more inclusive heterogeneous cohorts resulting in higher external validity to inform treatment practices. As reviewed in this article, well-designed comparative effectiveness studies are an important application of RWD. Although, like RCTs, observational studies have their own set of limitations, including various biases that may confound results, advanced statistical methods can mitigate many of these limitations. A focus on personalized treatment will continue to add value to individualize MS care.
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| http://dx.doi.org/10.1016/j.ncl.2023.06.003 | DOI Listing |
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