Why is an IND Required?
The IND is required to protect
public health by ensuring that new drugs are safe and effective before they are marketed. It provides a structured way for the FDA to oversee clinical research and ensures that investigators adhere to ethical standards and
Good Clinical Practices (GCP). Without an IND, a sponsor cannot legally ship a new drug across state lines for the purpose of conducting clinical trials.
What are the Types of INDs?
There are several types of INDs: Commercial IND: Submitted by companies intending to market the drug.
Research IND: Often submitted by individual investigators or academic institutions for research purposes.
Emergency Use IND: Allows the FDA to authorize the use of an experimental drug in an emergency situation.
Expanded Access IND: Provides patients with serious or life-threatening conditions access to investigational drugs outside of clinical trials.
What Information is Included in an IND Application?
An IND application contains three main types of information: Animal Pharmacology and Toxicology Studies: Data from
preclinical studies that demonstrate the safety of the drug for initial testing in humans.
Manufacturing Information: Details on the drug's composition, manufacturer, stability, and controls to ensure it can be produced consistently and safely.
Clinical Protocols and Investigator Information: Detailed plans for the proposed trials, including methodologies, participant criteria, and the credentials of clinical investigators.
How is an IND Reviewed?
Once submitted, the IND is reviewed by the FDA's Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The review process evaluates whether the drug is reasonably safe for initial use in humans and whether the clinical study is designed to ensure the safety of participants. The FDA may also consult with an advisory committee for additional insights.What Happens After IND Approval?
If the IND is approved, the sponsor can begin clinical trials, which are conducted in phases. Each phase aims to answer specific research questions and ensure the drug's safety and efficacy: Phase 1: Tests safety, dosage, and side effects with a small group of healthy volunteers.
Phase 2: Explores efficacy and side effects with a larger group of individuals who have the disease or condition.
Phase 3: Confirms effectiveness, monitors side effects, and compares the drug to commonly used treatments in a larger population.
Phase 4: Conducted after the drug has been approved for consumer sale, monitoring long-term effectiveness and collecting information on any rare side effects.
Can an IND be Placed on Hold?
Yes, the FDA can place an IND on hold if there are concerns about the safety of the participants or if the study design is inadequate. A clinical hold can be either a complete hold, where no part of the study can proceed, or a partial hold, where some aspects of the study can continue.Conclusion
The IND application is a fundamental aspect of
drug development, ensuring that safety and ethical standards are met before a new drug is tested in humans. Successfully navigating the IND process is a critical step for any pharmaceutical company aiming to bring a new drug to market.
