Good Clinical Practice GCP By Kris Traver and

Good Clinical Practice GCP By: Kris Traver and Nitin Jain

Goals and Objectives To understand: The affect of Good Clinical Practices on institutions conducting Clinical Research To discuss: What is GCP Guidelines for GCP The history of Good Clinical Practices Basic principles Practices and strategy for staying compliant with Good Clinical Practices.

What Is GCP? Good Clinical Practice (GCP) is defined as a ‘standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected’

Good Clinical Practice Guidelines Are mainly focused on the protection of human rights in clinical trial. Provide assurance of the safety of the newly developed compounds. Provide standards on how clinical trials should be conducted. Define the roles and responsibilities of clinical sponsors, clinical research investigators, Clinical Research Associates, and monitors.

Good Clinical Practice Guidelines (Continued) GCPs are generally accepted, international best practices for conducting clinical trials and device studies They are defined as an international ethical and scientific standard for designing, conducting, recording and reporting trials that involve the participation of human subjects Compliance with GCPs provide public assurance that the rights and safety of participants in human subject research are protected and that the data that arises from the study is credible

The Core of the Consolidated GCP Guidance 1 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 2 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 3 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society 4 The available non clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial 5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol 6 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion 7 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

Thirteen principles of GCP Guidance 8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective tasks 9 Freely given informed consent should be obtained from every subject prior to clinical trial participation 10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification 11 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements 12 Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol 13 Systems with procedures that assure the quality of every aspect of the trial should be implemented

History of Good Clinical Practice Prior to an actual set of guidelines to follow for good clinical practice, clinical studies were dangerous and could result in serous disease, or possibly death The Nuremburg Code of 1947 Experiments performed in germany during WWII opened the eyes of the world for guidance for clinical testing on humans. The code did set ethical guidelines, but it lacked legislation to back it up. Declaration of Helsinki In 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. These guidelines influenced national legislation, but there was no set standard between nations

History of Good Clinical Practice (Continued) The formation of the International Conference on Harmonization (ICH) led to the creation of the Consolidated Guidance on GCP The ICH consisted of the governments of the United States, EU and Japan coming together to develop common regulations for the pharmaceutical markets among member countries

Mission of the GCP Program The Good Clinical Practice Program is the focal point within FDA regarding issues in human research trials regulated by FDA. The Good Clinical Practice Program: Coordinates FDA policies Contributes to leadership and direction through participation in FDA's Human Subject Protection/Bioresearch Monitoring Council Coordinates FDA's Bioresearch Monitoring program with respect to clinical trials, working together with FDA's Office of Regulatory Affairs (ORA) Contributes to international Good Clinical Practice harmonization activities Plans and conducts training and outreach programs

Under GCP, the FDA Requires That People be Informed: The study involves research of an unproven drug, the purpose of the research How long the participant will be expected to participate in the study What will happen in the study Possible risks/benefits to the participant Participation is voluntary and that participants can quit the study at any time without penalty or loss of benefits to which they are otherwise entitled.

Procedures During a Clinical Trial? New drug research starts by studying how the body functions at its most basic levels. The first series of tests are on performed on Human enzymes and proteins to observe the basic effect. Next, the drug must be tested in living animals to ensure safety for human consumption. With this, drug companies make every effort to use as few animals as possible and ensure they are properly cared for. Then a protocol is created to map out what study procedures will be done, by whom, and why within a clinical trial.

What Happens in a Clinical Trial? (Continued) The trials are conducted in 4 phases. Phase 1 trials are for determining dosing, document how a drug is metabolized and identify side effects. Phase 2 trials gather further safety data and evidence of the drug's efficacy. Phase 3 further tests the product's effectiveness on a greater number of participants, and monitors side effects. Phase 4 trials can be conducted after a product is already approved and on the market to find out more about the treatment's long-term risks

What Happens in a Clinical Trial? (Continued) It is estimated that only 5 in 5, 000 compounds that enter preclinical testing make it to human testing, and only 1 of those 5 may be safe and effective enough to reach pharmacy shelves.