The Importance of Biomarkers to Clinical Trials, Part I
As an MS patient, you may be interested in the role and importance that biomarkers play in all MS clinical trials and diagnostics.
Clinical trials test experimental treatments for safety and effectiveness. They also compare it to other treatments and look at optimal uses of that treatment.
To truly measure the effectiveness of an MS therapy, scientists need accurate biomarkers to determine the progression or regression of the myelin damage. Biomarkers measure a biological process (e.g., levels of a specific protein in blood or spinal fluid; genetic mutations; or brain abnormalities observed in an imaging test) which is related to a particular disease and can serve as an indicator or predictor of that disease.
Currently, MS clinical trials rely on relapse rates and Expanded Disability Status Scores (EDSS), which are not accurate measures and can disguise the effects of the treatment. If it were possible to precisely and accurately measure myelin repair/damage in a blood test or imaging, patients could be diagnosed earlier, we could better determine the effectiveness of a treatment, and we would dramatically increase the speed of clinical trials by speeding up the measurement process.
While biomarkers are incredibly useful, few organizations fund their identification. The MRF is funding the development of key biomarkers because they are essential to speeding up and improving our research.
At this time, we are working on two particular biomarkers – Positron Emission Tomography (PET) scan and blood-based biomarkers.
My hope is that this information will empower you to become educated supporters, so that when you give to us, or to any other disease organizations you will understand the importance of biomarkers in the research and refinement of a treatment.
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