The clinical trial of IVD in vitro diagnostic reagents and medical devices is an important means to evaluate the detection and evaluation performance of such reagents in human samples.
In clinical trials, special attention should be paid to the selection of subjects and the collection of samples. Subjects should be from the population (target population) and indications claimed to be used for the intended use of the product, such as people with certain symptoms, signs, physiology, pathological status, or some epidemiological background. Enrollment of non-target populations may introduce subject selection bias, resulting in clinical trial results that do not reflect the true situation of the product. At the same time, subjects should exclude physiological or pathological features that are not suitable for this clinical trial.
In terms of sample collection, if the collection of subject samples is based on the subject selection requirements of other clinical studies, or not in accordance with any clinical study regulations, such samples are for this clinical trial as previous samples.
For in vitro diagnostic reagents such as rare genetic diseases, rare tumor gene mutations, and some low-incidence pathogen infections, the use of previous samples can effectively broaden the clinical research path and improve the practical feasibility.
However, the use of previous samples must comply with the requirements of laws and regulations such as the "Good Practice for Clinical Trials of Medical Devices", "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents" and relevant product technical review guidelines, and be subject to legality.
In addition, special attention should be paid to the consistency of operational details and relevant product instructions during the design and execution of clinical trials, including in vitro diagnostic reagent instructions for experiments, comparison reagent instructions and review reagent instructions.
For more information on clinical trials of IVD in vitro diagnostic reagents for medical devices, it is recommended to consult the relevant literature or consult a professional.