- Regulatory landscape across the drug development process
- Drug development begins to be FDA-regulated during preclinical studies
- Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) regulations must be followed during certain stages during drug development
- Repercussions of not adhering to good clinical practices
- Warning letters are sent to persons in clinical research for not following GCPs
- Define Good Clinical Practice (GCP)
- GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies
- GCP compliance provides public assurance that the rights, safety and well-being of human subjects in research are protected
- GCP Goals
- To protect the rights, safety, and welfare of humans participating in research
- To assure the quality, reliability and integrity of data collected
- To provide standards and guidelines for the conduct of clinical research
- Good Clinical Practice = Ethics + Quality Data
- (Brief) History of GCP
- Foundations of the ethical conduct of clinical research come from:
- The Nuremburg Code (1947)
- The Declaration of Helsinki (1964)
- The Belmont Report (1979)
- International Conference on Harmonization (ICH-GCP, 1997)
- International Standards Organization 14155
- Code of Federal Regulations
- Foundations of the ethical conduct of clinical research come from:
- ICH E6- GCP
- The goal of ICH is to harmonize technical procedures and standards; improve quality; and improve time to market
- FDA adopted ICH GCP Guidelines in 1997
- FDA Regulations as they relate to GCP
- 21 CFR 11 — Electronic Records & Signatures
- 21 CFR 50 — Protection of Human Subjects
- 21 CFR 54 — Financial Disclosure
- 21 CFR 56 — Institutional Review Boards
- 21 CFR 312 — Investigational New Drugs
- 21 CFR 812 — Investigational Device Exemptions
- 21 CFR 814 — Premarket Approval of Medical Devices
- FDA Biomonitoring Research Program (BIMO) GCP Inspections
- BIMO encompasses all FDA-regulated clinical trials, which are those related to human drugs and biological drug products, devices, foods, and veterinary medicine
- BIMO goals are (1) to protect the rights, safety, and welfare of subjects involved in FDA-regulated clinical trials; (2) to determine the accuracy and reliability of clinical trial data submitted to the FDA in support of research or marketing applications; and (3) to assess compliance with FDA’s regulations governing the conduct of clinical trials, including those for informed consent and ethical review
- BIMO is an on-site inspection by The Office of Regulatory Affairs for compliance, subject protection and data verification
Eunjoo Pacifici, PharmD, PhD
Director, Regulatory Knowledge and Support