What is GCP?
Good Clinical Practice guidelines are the standards to design, perform, supervise, audit, document, analyse and report clinical trials. GCP guidelines also assist to secure the legal rights, reliability and privacy of trial participants. The ‘Medicines for Human Use Regulations, UK 2004’ and the ‘EU Clinical Trial Directive’ on GCP has transformed the worldwide viewpoint on the ethical principles on clinical subject safety and rights. It has now become mandatory that all clinical studies which involve human subjects should be conducted according to ICH-GCP guidelines.
What is ICH-GCP?
The International Council for Harmonisation (ICH)-GCP are the standard guidelines that help to protect the privileges, safety and wellbeing of the clinical trial participants, prevents unethical human subjection to clinical trials, enhances quality of data, accelerates the marketing approval of new drugs and reduces the expense to sponsors and to the payers.
Reasons why GCP Guidelines have been formulated
- To increase the ethical attention of all stakeholders of clinical research
- As a composite body of information for better understanding of diverse concepts related to the ethical conduct of clinical trials
- For standardizing clinical trial methodologies for harmonization of data
- To reduce frauds and accidents in clinical trials
- To reduce the increasing R&D expenses
- For faster regulatory approvals of ‘Investigational New Drug Applications’ (IND) and ‘New Drug Applications’ (NDA) and a shorter time to market
Principle Guidelines of ICH-GCP
Clinical trials must be performed in compliance with ethical principles that have their foundation based on the Declaration of Helsinki, and that are in agreement with GCP and the applicable regulatory requirements.
- Prior to study start-up, possible risks, and inconveniences must be assessed in opposition to expected advantage for the individual trial participant and community. A study should be started and carried on only if the estimated advantages justify the dangers. The principle of beneficence, benevolence and the Hippocratic principle of non-maleficence take paramount importance in justifying the risk-benefit ratio.
- The privileges, safety and welfare of the trial participants are the most essential concerns and should overcome over interest of science and society.
- Prior non-clinical and clinical data on a research product must be adequate and justify the rationale of a proposed clinical trial.
- Clinical studies must be scientifically sound, and explained in a valid, explicit and specific protocol.
- A clinical trial should be performed in accordance with the protocol that has obtained a valid IRB/IEC approval.
- The medical treatment provided, and medical judgements taken on behalf of clinical trial participants should usually be the responsibility of a qualified doctor or, when required (when performing clinical trials of dental related products), of a qualified dentist.
- Each person engaged in performing a clinical trial must be qualified by education, training, and experience to carry out his or her particular duties.
- Informed consent must be obtained from every clinical trial subject before the clinical trial starts.
- All clinical trial details must be documented, handled, and kept in a way that enables its appropriate reporting, interpretation and audit.
- The documents that could recognize participants should be secured, respecting the confidentiality and privacy guidelines in accordance with the appropriate regulatory requirements (e.g., Health Insurance Portability and Accountability Act, 1996).
- Investigational products must be produced, handled and stored in compliance with appropriate Good Manufacturing Practice (GMP). They must be used in compliance with the accepted protocol.
Good Clinical Practice (GCP) in Asia Region
After the establishment of ICH-GCP guidelines, many nations in Asia have realized the importance of GCP guidelines and prepared their own GCP guidelines dependent on the design of the original guidelines.
|Name of GCP Guidelines||Year of establishment|
|Malaysian – GCP||1999 and revised in 2004|
|Saudi Arabian SFDA – GCP||2013|