Safety in

Clinical Trials

As mentioned previously, clinical trials require a vast amount of preparation before it can begin looking for participants. In this section we will explain how clinical trials are regulated to ensure the safety of all of its participants. We will go over the role of ethics committees, Good Clinical Practice (GCP) guidelines and regulatory agencies in the development and running of a clinical trial.
Investigation Ethics Committee (IEC) or Institutional Review Board (IRB)
An IEC or IRB is a validated organization formed by a group of experts, who’s aim is to ensure that patients’ rights are protected, and their safety is ensured. A clinical trial involving humans must be reviewed by an ethics committee to ensure that the methodology and ethical aspects follow current rules and regulations. This ethics committee must approve the clinical trial design before it can start, as well as supervise the ongoing clinical trial once it is approved. Any changes to the clinical trial must be approved by the ethics committee before being implemented.
Good Clinical Practices (ICH GCPs)

In 1997, country specific Good Clinical Practices guidelines were harmonized into a global entity: International Committee on Harmonization of Good Clinical Practices (ICH-GCP). GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Quality assurance and inspections ensure that these standards are achieved.

These guidelines include protection of human rights for the volunteers participating in a clinical trial and provides assurance of the safety and efficacy of the medication.

In summary, they look after the patient’s safety and wellbeing and establish this as the main priority, over the study’s objectives.

Regulatory Authorities/Agencies (RA)
A regulatory agency is an independent government body, who’s purpose is to set standards in a specific field of activity. In the US, the regulatory agency is the FDA. In Europe, it is the EMA. Each country also has its own specific RA but may require approval from a centralized RA before moving forward with a clinical trial. In the pharmaceutical industry, the RA guarantees que quality, safety, efficacy and correct labelling of medication and medical products available to the public. They are involved throughout the whole drug lifecycle, from investigation and development of a product to post-marketing evaluation.
Main Regulatory Agencies in the world
HMA

Heads of
Medicines Agencies

EMA

European
Medicines Agency

FDA

Food & Drug
Administration

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