What is the primary purpose of Good Clinical Practice (GCP)?

The primary purpose of Good Clinical Practice (GCP) is to ensure the safety and rights of human subjects. This framework is established to protect participants involved in clinical trials, emphasizing the ethical and scientific quality of research. By adhering to GCP guidelines, researchers are required to conduct trials that prioritize the well-being and rights of participants, ensuring informed consent is obtained and that individuals are not subjected to unnecessary risks.

This focus on participant safety helps maintain public trust in clinical research, which is essential for the advancement of medical science. GCP provides a systematic approach to think critically about participant welfare, holding researchers accountable for ethical conduct and ensuring that studies are implemented with integrity.

While promoting new drug development, increasing clinical trial efficiency, and standardizing clinical trials globally are important aspects of clinical research, they are all secondary to the fundamental goal of protecting human subjects. The protection of rights and safety thus forms the cornerstone from which all other aspects of clinical research emanate.