Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Quality Management in clinical trials: Comparison of the requirements stated in the Integrated Addendum to ICH E6(R1) Guideline for Good Clinical Practice E6(R2) for medicinal products and the ISO 14155:2011 for medical devices ***

Dr. Dimitrios Mintsioglou (Abschlußjahr: 2017)

Summary
Language: English
The aim of conducting clinical trials is the identification of new treatment options and standards firstly tested in a well-defined, limited population in order to benefit the larger population. Ultimately, clinical trials, either with medicinal products or with medical devices, are the only way to make sure that new treatments are safe and effective. However, it is of utmost importance that the clinical trials are conducted with high quality standards.
Quality is defined as the total set of characteristics of a product or service that affect its ability to satisfy a customer's stated or implied needs. The definition of a quality system is that it contains the organizational structure, responsibilities, processes, procedures and resources for implementing quality management. Quality Management (QM), on the other hand, includes those aspects of the overall management function that determine and implement the quality policy and quality objectives. Therefore, a quality system is quite different from a QM system. A quality system typically focuses on a few areas of quality practices (techniques), such as written SOPs while a QM system is more comprehensive concept.
The adoption of a QM system in clinical trials has proven to be more challenging and in the literature it is being argued that measuring quality in clinical trials is quite difficult. Research and development of pharmaceuticals or medical devices is a time-consuming and complex process, demanding a good understanding of medical and regulatory requirements paired with the ability to manage sophisticated clinical trials, which are often to be conducted within a tight timeframe.
A QM system specifically designed for clinical trials should be proactive, flexible and responsive in order to be able to manage quality holistically and systematically in all aspects and all phases of a clinical trial. Importantly, this QM system should contain specific elements that would give the organizations and institutions involved in clinical trials the means to achieve their quality objectives by ensuring on the one hand that quality is built-in to the trial from the beginning and on the other hand by identifying and resolving quality compromising issues during the course of the trial.
In this work the QM concepts as defined in the ICH GCP guideline, for medicinal products, and in the ISO 14155:2011 standard, for medical devices, are being outlined and compared between them. Furthermore, since Risk Management is one of the most essential and mandatory component of an effective QM system for clinical trials, the Risk Management requirements for medicinal products and medical devices are discussed. The Risk Management process is outlined and differences between medicinal products and medical devices are being presented.  
Implementation of a robust risk-based Quality Management System for clinical trials is not just a prerequisite set in the various regulatory documents, guidelines and laws but also imperative for improving trial performance and safeguarding patient safety and integrity of data.
Pages: 69