Control Mechanisms of Investigational Drugs
Control mechanisms ensure the integrity and ethical conduct of clinical trials:
Regulatory Oversight: Regulatory agencies, such as the FDA or EMA, review and approve study protocols, monitor compliance, and have the authority to halt studies if necessary.
Institutional Review Boards (IRBs): Independent committees review research proposals to uphold ethical standards and protect participant rights.
Standard Operating Procedures (SOPs): Detailed, written instructions provide consistency in performing specific trial functions, ensuring reliability and adherence to protocols.
Data Monitoring Committees (DMCs): Independent groups that oversee patient safety and treatment efficacy data as trials progress.
Identification of Investigational Drugs
Accurate identification of investigational drugs is essential for proper tracking and usage:
Labeling: Labels must state "For Investigational Use Only" and include necessary details for accurate identification and handling.
Unique Codes: Each investigational drug is assigned a unique identifier to track it throughout the trial.
Blinding: In double-blind studies, labeling is designed so that neither participants nor investigators know who receives the investigational drug or placebo, maintaining unbiased results.