Clinical research is the most crucial and essential step that leads to the safe development of new medicines, medical devices, and treatment therapies. At the core of this vital field are standards known as Good Clinical Practice (GCP). These guidelines ensure that the rights, safety, and well-being of subjects who take part in the clinical trial studies are protected, and the confidentiality of this data is maintained and accurate. GCP is the paramount pillar of clinical research, coordinating the different steps and professionals as well as participants involved in developing new therapies. In this blog, we will discuss the important factors about ICH-GCP. So let’s dive in.
What is Good Clinical Practice?
GCP stands for Good Clinical Practices in clinical research and came into existence as a response to the violations of historical ethical principles in research, such as the Nuremberg Trials and the Tuskegee Syphilis Study. These historical events highlighted the urgent need for formalised protections for human subjects or clinical study participants. The ethical foundation was laid by the Declaration of Helsinki (1964), and later, the International Council for Harmonisation (ICH) developed the ICH-GCP E6 guideline, which has since become the global benchmark. Regulatory bodies like the U.S. FDA, EMA, and CDSCO in India mandate GCP compliance for clinical trials intended to support drug approval.
Good clinical practices play the role of a rule book that mentions the precise way to conduct clinical research. It ensures the safety of human participants in the clinical trials. Researchers have to abide by the rules mentioned in GCP about how to conduct studies and report their findings. This helps to ensure the safety and effectiveness of the medicines or treatment therapies before they are used on many people. It helps to ensure that the rights, safety, and well-being of participants are protected, and that the data generated is reliable and credible and accurate.
What is ICH?
ICH stands for the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. It is a global organisation that is responsible for bringing together representatives of the regulatory authorities and the pharmaceutical industry. It aims to create common standards for drug development and registration. The ICH ensures that medicines are developed and tested under consistent and high-quality standards by harmonising guidelines across countries. This helps to avoid duplicate studies and speeds up the approval process, and ensures the safety of the patients with effective medicines and treatments.
The 13 Principles of ICH-GCP
The ICH has outlined 13 core principles that guide Good Clinical Practice:
- Ethical Conduct: The clinical trials must follow ethical principles based on the Declaration of Helsinki.
- Risk vs. Benefit: It is most important that the benefits must always outweigh the risks.
- Participant Rights: Participant safety and rights take precedence over scientific interests.
- Adequate Information: Trials should be backed by sufficient non-clinical and clinical data.
- Sound Protocol: Studies must follow a scientifically sound and detailed protocol.
- Independent Review: An Ethics Committee/IRB must approve and monitor the trial.
- Medical Oversight: Qualified medical professionals should be responsible for participant care.
- Qualified Staff: All personnel must be trained and experienced.
- Informed Consent: Voluntary informed consent is required from every participant.
- Accurate Data: Data must be recorded, handled, and stored accurately and securely.
- Confidentiality: Privacy and confidentiality of participants must always be protected.
- GMP Compliance: Investigational products must be manufactured and stored per Good Manufacturing Practices.
- Quality Systems: All trial processes should be implemented under quality assurance systems.
Importance of GCP in Clinical Research
Good Clinical Practices in clinical research is a regulatory checklist as well as the framework that helps to ensure the transparency, accountability and trust in clinical research. Here are a few important aspects of GCP in clinical research
- It protects the participant’s safety and rights.
- Ensures the credibility of data collected during research.
- Helps promote global acceptance of clinical trial results.
- Maintains ethical standards in human research.
Note: For professionals in clinical research, GCP training is not just beneficial but mandatory to ensure compliance and integrity.
Conclusion
Good Clinical Practices is the backbone of clinical research. India is the hub of clinical trials. Trained ICH-GCP principal professionals are in high demand in India and abroad. But getting industry-oriented knowledge and certification can be confusing and challenging. CareerInPharma helps freshers and professionals to achieve this industry-oriented knowledge about GCP principles and helps them achieve their dream job. CareerInPharma Offers Courses like Diploma in Clinical Research and Pharmacovigilance that make you a trained and expert professional in the Clinical Research field.
