Last month I talked more in depth about ethics review as a critical part of the first stage of the research process when conducting any study on human subjects. So this month, let’s move forward to the “Recruitment, Data Collection” stage of the research process and talk about one aspect that’s often a focus of an ethics review: the collection of biological materials from participants.
One important aspect of designing a study is determining the number of participants that will be included. It’s a difficult balance between trying to design a study with the best odds of producing an impactful result and working within the resources available.
At OMF, we try to use our resources wisely, focusing on scientifically rigorous research that has the potential to guide future research and patient care as quickly as possible. Conducting well-powered research is a big part of that mission, so I want to explain a little bit about what that means from a science perspective and how it impacted the design of our first clinical trial.
Biosamples are biological materials that are collected from human subjects for research or medical purposes and are typically stored in a biobank. There are numerous types of biosamples, and each type of biosample has its own use cases in research and medicine.
There is a wide variety of biological samples that are used in research, including:
Given the lack of a clear understanding of the disease mechanism and diagnostic tool for ME/CFS, biosamples are crucial for research in the field. Testing on biosamples provides objective measurements that can provide insight into the pathophysiology of the disease and potentially yield a diagnostic and/or prognostic biomarker. Test results performed on biosamples are also important components of clinical management of ME/CFS, particularly when combined with symptom presentation.
OMF utilizes biosamples in the vast majority of its research studies. One example is a project conducted at OMF’s Collaborative Center at Uppsala, in which the team is analyzing the CSF of people with ME/CFS. This project will help gain a better understanding of what’s going on in the central nervous system and aim to identify changes in the proteome based on clinical severity and the presence of postural orthostatic tachycardia syndrome. Read more about the study on our website.
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