THE ..13- PRINCIPLES- OF- ICH-GCP .pptx
- 1. PRINICIPLES OF ICH-GCP ENSURING QUALITY AND INTEGRITY IN CLINICAL TRIALS International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Presented by Zamran Khan
- 2. WHAT IS ICH? The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical guidelines and requirements for pharmaceutical product registration. Launched in April 1990 by the US, EU, and Japan. Current version used is E6(R3).
- 3. GOOD CLINICAL PRACTICES(GCP) GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
- 4. DECLARATION OF HELSINKI The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964.
- 5. PRINICIPLES OF ICH-GCP The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines are a set of internationally recognized standards for conducting clinical trials. The 13 principles of ICH GCP are designed to ensure the safety, rights, and well-being of trial participants, and to maintain the integrity and credibility of clinical trial data. Here’s a detailed explanation of each principle based on ICH GCP E6(R3):
- 6. 1. ETHICS: Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements. Example: In a clinical trial testing a new Alzheimer's drug, researchers ensure ethical compliance by obtaining informed consent from participants and their legal guardians , clearly explaining the trial's risks and benefits, and ensuring that participants understand they can withdraw from the study at any time without penalty. Additionally, the trial is designed to minimize potential harm by closely monitoring participants for adverse effects and providing appropriate care if any issues arise.
- 7. 2. TRIAL RISK VS TRIAL BENEFIT: Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. Trial Risk: This includes all potential negative outcomes or harm that participants might face during the trial. Risks can be physical (e.g., side effects from a drug), psychological (e.g., anxiety from participation), social (e.g., stigmatization), or economic (e.g., cost of participation). Trial Benefit: This refers to the positive outcomes that may arise from the trial. Benefits can be direct, such as improvement in the participant’s health, or indirect, such as contributions to scientific knowledge that could benefit future patients. Balancing Risk and Benefit: The core of the risk-benefit assessment is ensuring that the potential benefits of the trial justify the risks involved. If the risks outweigh the benefits, the trial may not be ethically acceptable. Example: Testing a new cancer treatment carries the risk of severe side effects but offers the potential benefit of significantly improving survival rates for patients with few other options.
- 8. 3. TRIAL PARTICIPANTS: The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Participants can withdraw from the clinical trial at any point without providing a reason, and without any penalty or loss of benefits to which they are otherwise entitled. Participants have the right to be informed about any new information that may affect their willingness to continue in the study. Participants should receive appropriate medical care for any adverse events related to the clinical trial. This includes access to medical treatment and follow-up care. Participants have the right to be treated fairly and equitably throughout the trial, without discrimination based on age, gender, race, or socioeconomic status. The safety of trial participants is continuously monitored throughout the study to ensure that any risks are minimized and managed appropriately. Example: In a clinical trial for a new antidepressant, participants are informed about the study's risks and benefits, given the right to withdraw at any time, and their personal data is kept confidential.
- 9. 4. GOOD QUALITY TRIALS: The trial should be scientifically sound, and described in a clear, detailed protocol. Quality of a clinical trial is considered in this guideline as fit for purpose. The quality and amount of the information generated during a clinical trial should support good decision making. The methods used for participant selection, data collection, and data analysis must be robust and standardized to minimize bias and errors. Statistical methods must be appropriate for the study design and capable of accurately analyzing the data to draw meaningful conclusions. Example: A randomized, double-blind study design ensures scientific soundness by minimizing bias and allowing for reliable comparison between a new cancer drug and a placebo.
- 10. 5. INFORMATION ON THE MEDICINAL PRODUCT The available non-clinical and clinical information on an Investigational Product should be adequate to support the proposed clinical trial. This information is crucial for ensuring that all parties involved in the trial, including investigators, sponsors, ethics committees, and regulatory authorities, have a clear understanding of the product's characteristics, potential risks, and expected benefits. Investigator’s Brochure (IB): A critical document that provides the clinical investigator with relevant information about the investigational product, including its pharmacological properties, toxicity data, and the results of previous clinical studies. Example: The Investigator’s Brochure for a new diabetes drug details its mechanism of action, dosage guidelines, and safety profile, ensuring investigators are well- informed for the clinical trial.
- 11. 6. COMPLIANCE WITH REGULATORY REQUIREMENTS(IRB/IEC) A trial should always be conducted in compliance with the protocol that receives prior IRB/IEC approval/favorable opinion. Periodic review of the trial by the IRB/IEC should also be conducted in accordance with applicable regulatory requirements. Example: Submitting an Investigational New Drug (IND) application to the FDA and receiving approval before starting a new cancer drug trial ensures compliance with regulatory requirements.
- 12. 7. MEDICAL DECISIONS: The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist. Medical decisions in ICH GCP are critical to maintaining the ethical and scientific integrity of clinical trials. Example: If a participant experiences an adverse event, the investigator, who is a qualified physician, must assess the situation, decide on the necessary medical intervention, and determine whether the participant should continue in the trial or not.
- 13. 8. QUALIFIED INVESTIGATORS: Investigators conducting the trial should be qualified by education, training, and experience to perform their respective tasks. Example: A principal investigator leading a clinical trial on a new cancer treatment is a board-certified oncologist with extensive experience in clinical research.
- 14. 9. INFORMED CONSENT: Freely given informed consent should be obtained from every subject prior to clinical trial participation. Informed consent is an integral feature of the ethical conduct of a trial. For potential participants unable to provide informed consent, their legally acceptable representative should provide consent prior to clinical trial participation Example: Before enrolling in a clinical trial, a participant is given detailed information about the study, including its purpose, duration, procedures, risks, and potential benefits. The participant then signs a consent form indicating they understand and agree to participate.
- 15. 10.CLINICAL TRIAL DATA: All clinical trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and verification. Example: A study coordinator maintains detailed records of patient visits, medication dispensation, and adverse events, ensuring that all data is documented in the case report forms (CRFs) and stored securely.
- 16. 11.CONFIDENTIALITY: The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements. Example: Researchers store patient data in a secure, encrypted database, ensuring that only authorized personnel have access to personally identifiable information.
- 17. 12. GOOD MANUFACTURING PRACTICE(GMP): Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be stored, shipped, handled and disposed of in accordance with the product specifications and the trial protocol. Measures should be in place to ensure that the investigational product provided to trial participants retains its quality. Investigational products should be used in accordance with the protocol and relevant trial documents. Example: A pharmaceutical company developing a new drug ensures that the manufacturing process for the drug is validated, meaning that it consistently produces a product that meets the predefined quality criteria. This includes testing the purity, potency, and stability of the drug throughout its production. The drug is stored in temperature-controlled warehouses and shipped under strict conditions to clinical trial sites, ensuring that its potency and safety are maintained throughout the process.
- 18. 13. QUALITY ASSURANCE(QA): Quality Assurance (QA) in the context of ICH GCP refers to the systematic processes and procedures put in place to ensure that clinical trials are conducted, data is generated, documented, and reported in compliance with the study protocol, GCP guidelines, and applicable regulatory requirements. QA includes conducting audits, which are independent and systematic examinations of trial-related activities and documents to ensure compliance with the protocol, SOPs, and regulatory requirements. Example: A sponsor establishes a quality management system that includes standard operating procedures (SOPs), regular audits, and staff training to ensure the trial is conducted in compliance with GCP and regulatory requirements.
- 19. CONCLUSION The ICH GCP principles provide a comprehensive framework for conducting ethical and scientifically sound clinical trials. Adherence to these principles is essential for the protection of participants and the integrity of the data collected. Ongoing commitment to these principles ensures the success and credibility of clinical research. These principles are designed to safeguard participants and ensure the credibility of clinical trial results, thereby contributing to the advancement of medical knowledge and public health.
- 20. THE END