This paper discusses the features of measurement in clinical trials. Factors that affect the measured parameters in the laboratory and clinical conditions have been analyzed. The measurement model in clinical trials taking into account the nontherapeutic factors impact has been proposed. The causes and sources of uncertainty arising from the measurement of evaluation criteria of new drugs properties have been identified and classified.
measurement uncertainty, clinical trials, measurement model, impact factors
“Modelirovanie protsessov izmerenii pri klinicheskikh ispytaniiakh lekarstvennykh sredstv”,
Information Processing Systems,