The term “quality”, when talking about clinical trials, is related to various elements and concepts. But what are the basics of quality that any clinical trial should meet? On what grounds is quality based when we talk about drug-related clinical trials? What quality aspects should sponsors ensure when they start a new trial?
In essence, clinical trial sponsors, through their collaborative contract research organizations (CROs), must implement and maintain a quality management system to ensure that trials are carried out properly and the data are generated, registered, and communicated in compliance with the protocol, the standards of Good Clinical Practice (GCP), and regulatory requirements.
The ultimate goal of the quality system is to ensure patient protection and the reliability of research results.
Some key elements of a clinical trial quality system are summarized below:
1.- Identification of critical processes and data. The objective is to identify critical trial processes and data, which are essential to ensure patient protection and the reliability of results.
These data are reviewed before the study begins and serve as a basis for the monitoring plan.
2.- Risk management. The risks of the clinical trial should be identified, assessed, monitored, communicated and reviewed so that they can be prevented and mitigated. These risks can potentially affect critical trial data, and that is why it is so important to control them from the start.
3.- Control of the roles and responsibilities of the site’s staff. The purpose is to ensure that members of the research team, located in hospitals, understand their roles and responsibilities, controlling any changes in the research team during the course of the investigation.
4.- Control of site staff trainings. This action seeks to ensure that the research staff receives specific training of the study, verifying that the members of the team are qualified to carry out their tasks at all times.
5.- Audits and inspections. The audits carried out by the sponsors and the inspections of the regulatory authorities intend to verify compliance with the standards of good clinical practice, the quality of the data and the conformity of the study with the applicable legislation.
6.- Document management. The aim is to ensure the availability, integrity, accuracy, and storage of the study documents and the conformity of the communication actions.
7.- Control of corrective and preventive actions. In clinical trials, it is essential to ensure the prevention and resolution of major deviations from the protocol. This can involve the implementation of CAPA plans (corrective and preventive actions).
Clinical trial sponsors have an important responsibility to ensure the quality aspects described above. The role of a quality manager becomes crucial in this type of activities.
CROs specialized in trial management provide fundamental support to ensure these quality elements in the studies and are a very valuable ally for the overall success of the project.