Clinical research involve testing drug safety and efficacy in humans through four key phases. The four key phases can be listed as
Phase 0 - During this phase only few subjects are involved in which we check the mechanism of the drug at a very low dose.
Phase 1 - this phase involves determination of safe dose having 10-15 volunteers in which dose is escalated.
Phase 2- main objective is to evaluate safety and efficacy involving 100-200 volunteers in which we check for major side effects.
Phase 3- we compare the drug with some standard therapy on 100+ subjects and confirms the therapeutic value.
Phase 4- also known as post marketing surveillance often aims for detecting major side effects on 1000+ patients.
During the whole process IND (Investigational New Drug Application plays a major as a part of regulatory affairs. It allows a sponsor to begin human trails of a certain drug.
Types of IND
Commercial IND :- for drugs intended to be send to the market.
Research IND:- for academic and research purpose.
Investigation IND:- submitted by a physician who is doing the study.
Emergency IND:- for life threatening diseases spreading world wide suddenly where time is limited. For example:- COVID vaccines.
Treatment IND: For promising drugs under clinical evaluation.
Screening IND: For testing related compounds or formulations.
So for proper and ethical clinical trails we need to have prior knowledge about all these regulatory bodies and their roles and responsibilities to avoid any cancellations as well as any major catastrophic events.
Informative! Truly said, such regulatory bodies play key role in research and development of a particular drug or treatment and thereby resulting in their commercialization. Proper rules and regulations, reference parameters, and many other aspects make the drug discovery and process to be carried out in proper manner.
Informative. These steps show the immense effort and time required for a drug to reach the market. These regulatory bodies, in turn, play a crucial role in protecting our lives.
Informative! It explains how long does it take for the development of a certain drug and the regulatory bodies which ensure the safety and efficiency of those drugs.
A well-structured overview of clinical trial phases and IND types, especially useful for students entering clinical research. Regulatory knowledge alongside ethics shows a strong understanding of how safety and compliance go hand in hand. A solid foundation like this is essential to prevent errors and ensure responsible drug development.
This article does a good job explaining the importance of the IND/CTD process in clinical research. Submitting an Investigational New Drug application ensures that new therapies are evaluated rigorously for safety and efficacy before they’re tested in humans. It shows how regulatory oversight is essential for protecting participants and maintaining scientific and ethical standards throughout clinical trials.