the debate over harmonization in clinical research
Laboratories carry out tests in different ways, from test to test and lab to lab. This can cause discrepancies that affect results. The results are important since they are used to determine the health status of the patient and the kind of treatment they will get. These discrepancies have increased the need for harmonization to improve the healthcare 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 medical results for lab procedures can be catastrophic. Medical personnel who are not familiar with the procedures can interpret the results wrongly. This can result in patients getting the wrong diagnosis and treatment. A fixed laboratory value is used in many clinical guidelines to make treatment 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 Can It Be Done?
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 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 in improving healthcare 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. It will also help improve patient care by ensuring that patients get the right diagnosis. New ways to improve laboratory procedures can be researched that will improve clinical laboratory procedures.
Topics: Clinical Diagnostics