PD Biomarker Guidelines Published to Potentially Enhance Treatment Development
This past month, a set of guidelines, or recommendations, for the use of biomarkers in Parkinson’s disease (PD) research was published in Science Translational Medicine.1 A biomarker is a biological molecule that can be found in the body, specifically in the blood or other bodily fluids, that indicates the presence of a condition or abnormal process. Although biomarkers are often used to signify when something is going wrong, they can also be used to identify healthy processes in the body and to determine the absence of a condition. Biomarkers can also be monitored to see how a condition progresses over time, as well as to determine if it is responding to treatment.2
Why are biomarkers important?
There are a wide variety of biomarkers used in today’s healthcare landscape to assess conditions from cancer to Alzheimer’s to PD, and everything in between (including non-condition-related processes). Discovering and developing biomarkers can be a time-consuming process. However, as new technology has arisen, and a larger, collective knowledge base has been established, the use of biomarkers in clinical trials and treatment planning is becoming more of a reality, especially in the case of PD.
Who was part of the collaboration?
A team of researchers and experts from academic medicine, foundations, industry, and the government collaborated to evaluate the potential use of biomarkers within the PD treatment and research landscapes. This group published their recommendations for future investigators to consider for years to come. The team was led by Dr. Alice Chen-Plotkin of the Perelman School of Medicine at the University of Pennsylvania. Additionally, The Michael J. Fox Foundation for Parkinson’s Research was one of the 36 groups involved in creating these guidelines. The original ideas for the paper came from discussions at a Biomarkers Discovery Workshop in March 2016 that was led by The Michael J. Fox Foundation, as well as from the National Institute of Neurological Disorders and Stroke Parkinson’s Disease Biomarkers Program’s 2016 annual meeting.3
In the bulk of past research, biomarkers have been used in PD research to distinguish individuals with PD from those who don’t have the condition. However, the guidelines set forth in this paper suggest that biomarker use can be expanded in this population to further classify PD itself and to identify different sub-groups of PD-affected individuals within the overall PD population. Identifying specific populations who are at a higher risk of developing certain symptoms, or of progressing faster than others, using biomarkers may help better determine the most efficient treatment options. This approach may also help facilitate targeted clinical trials aimed at developing more impactful treatment options for specific groups of PD-affected individuals.
Research paper aims
Three areas are investigated in the paper including resources for biomarker collaboration, research principles to follow when using or studying biomarkers in clinical trials, and the types of biomarkers that might be beneficial to consider when developing new treatment options. The investigators also call for a standardization of used in screening for and using biomarkers, such as replication across multiple groups of individuals and utilizing larger sample sizes in studies. The leaders of the study also call out potential banks of biomarkers that have arisen as a result of previous research that could be used to enhance general PD biomarker knowledge and usage in the future.1
Overall, the study leaders are aiming to create principles that will create harmony amongst current and future biomarker-related findings, as well as advance (and streamline) the discovery and utilization processes of these potentially critical bodily indicators.1
For now, the guidelines for these biomarkers are for research purposes. At this point, biomarkers are not being used in the treatment of people with PD outside of clinical trials.
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