1. How Are Clinical Trials Conducted?

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To obtain approval for a clinical trial, the Clinical Trial Application (CTA) must be submitted to regulatory bodies called competent authorities. A Research Ethics Committee (REC) also reviews the protocol and gives a positive or negative opinion. This is to ascertain that the research respects the dignity, rights, safety and well-being of the people who are participating. In order to ensure compliance with ethical standards, the majority of clinical trial protocols are developed in line with the ‘Declaration of Helsinki’, a set of ethical standards for research involving human beings, human material or identifiable data, developed in 1964 by the World Medical Association (WMA) and revised several times.

Clinical trials on medicines are conducted in the European Union (EU) in compliance with regulations, directives and guidelines. The standard to which clinical trials are conducted is called Good Clinical Practice, as defined in a guideline by the International Conference on Harmonisation (ICH-GCP). This is an international quality standard that must be applied in all member states of the EU and describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and ethics committees. GCPs cover aspects of monitoring, reporting and archiving of clinical trial data and incorporating supplements on the Essential Documents and on the Investigator's Brochure which had been agreed earlier through the ICH process.