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In the US, use of the Mitra device with blood is limited to research and non-diagnostic applications. In many countries outside the US, the Mitra device is approved as a remote blood sample collection device for some clinical applications, as referenced in some content.

the debate over harmonization in clinical research

by Neoteryx | 2 min read

shutterstock_566980591Clinical research laboratories carry out testing or analysis in different ways during drug trials and other studies. This can cause discrepancies between labs that may affect results. The results are important since they are used to determine the health status of a study participant and the kind of benefits or side effects the participant will experience. These discrepancies have increased the need for harmonization to improve the system.

What Is Harmonization?

Harmonization is an endeavor that aims to achieve comparable results even when different procedures are used. It can be easily confused with standardization, which is achieving comparable results by having a reference measurement procedure that can be used to calibrate the results. Standardization is mainly used for academic purposes while harmonization is not limited to the world of academics.

What Harmonization Will Do

Different results for lab procedures can be catastrophic. Personnel who are not familiar with the procedures can misinterpret the results. This can result in the effects on study participants being misinterpreted, and outcomes being incorrectly reported. A fixed laboratory value is used in many clinical guidelines to make decisions. For this to continue being effective, the results need to be harmonized.

Clinical research will also benefit from harmonization since different trials will be harmonized in central labs. Results obtained from clinical trials will not be useful until there are factors in place to harmonize the results.

How Lab Results Can Be Harmonized

Harmonization can be achieved by combining different methods using a secondary referencing material. The calibrator will be used as a measurement standard for the tests and can be used to interpret the results. There is a problem with this theory. Many secondary reference materials are not agreeable with clinical research lab procedures. Different samples will produce similar results. However, it is not uniform when it comes to actual samples.

Bodies such as the AACC are trying to develop infrastructures for harmonizing different clinical trials worldwide. If successful, it will make communication more transparent between both local and international organizations. This will go a long way to improving clinical trials and outcomes by giving measurements for those procedures that do not have measurement standards.

When it comes to clinical research, a lot can be done to improve it. One of these things is incorporating harmonization in laboratory procedures. Once the research is translated to clinical settings, harmonization will also help improve patient care by ensuring that patients get the right lab results and, thus, the right diagnosis. 

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Originally published Aug 27, 2018 12:01:00 AM, updated on February 17, 2021

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