Monitoring metrics over time: Why clinical trialists need to systematically collect site performance metrics

نویسندگان

چکیده

Background: Over the last decade, there has been an increasing interest in risk-based monitoring (RBM) clinical trials, resulting a number of guidelines from regulators and its inclusion ICH GCP. However, is lack detail on how to approach RBM practical perspective, insufficient understanding best practice. Purpose: We present method for trials units track their metrics within using descriptive statistics visualisations. Research Design: suggest visualisations SWAT methodology. Study Sample: illustrate this TEMPER, study carried out three at MRC Clinical Trials Unit UCL. Data Collection: The data collection TEMPER described DOI: 10.1177/1740774518793379. Results: show results discuss protocol Study-Within-A-Trial (SWAT 167) those wishing use method. Conclusions: potential benefits metric tracking brings include enhanced assessment sites corrective action, improved evaluation contextualisation influence thresholds, establishment practice RBM. standardisation such would benefit both individual community.

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ژورنال

عنوان ژورنال: Research methods in medicine & health sciences

سال: 2022

ISSN: ['2632-0843']

DOI: https://doi.org/10.1177/26320843221147855