Good clinical practice: How to ensure excellence in Indian research landscape

Clinical research, which involves studies in human participants, is required for translating experimental scientific discoveries into real-world healthcare solutions.

- DR VENKATA S. RAM

It includes a wide variety of investigations—from trials testing new diagnostic tools, drugs, and medical devices, to studies exploring innovative therapies.

As a cornerstone of medical advancement, clinical research is behind much of the progress we see in modern medicine.

Many of today's most important medical interventions, including the polio vaccine and several chemotherapy drugs, became possible only through rigorous clinical trials.

These studies thus carry enormous responsibility, not just in terms of producing reliable scientific data but also with regard to upholding the highest ethical standards.

Because human participants are involved in this work, protecting their rights, safety, and well-being is paramount.

Hence, the concept of Good Clinical Practice, or GCP, is essential in clinical research.

GCP refers to an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve human subjects.

Its primary aim is to ensure that clinical research is not only scientifically valid but also ethical.

Originally developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 1996, GCP has since been adopted worldwide, including in India, and is now considered the gold standard for conducting clinical research.

Its principles are rooted in the Declaration of Helsinki (1964), a landmark document that outlined the fundamental ethical guidelines for medical research involving human beings.

The core principles of GCP are based on a commitment to ethical conduct and scientific soundness.

The principles of GCP dictate that clinical trials must comply with the Declaration of Helsinki as well as all applicable regulatory requirements.