Understand the possible benefits, risks and your rights as a participant should you decide to participate in a clinical trial.
A clinical trial is a research study conducted to investigate new treatments, such as a new drug compound or an existing therapy, in human volunteers or research participants. Each clinical trial is designed to learn about a potential treatment and its effect on humans.
Before a new treatment is tried on humans, extensive laboratory tests are done to identify promising compounds, and safety tests are conducted to
determine possible risks. The treatment with the most promising results is then moved into clinical trials.
Clinical trials are regulated under the FDA Act and their subsidiary legislations. The system of regulation requires
that Principal Investigators (PI) conducting clinical trials to obtain both ethics and regulatory approvals before initiating a clinical trial.
Ethical approval is provided by the Institutional Review Board (IRB) and regulatory approval is provided by us. In order to receive
ethical and regulatory approval, companies must provide relevant evidence that the investigational drug is acceptably safe, and the
design and conduct of the trial provide adequate levels of protection for the participants.
Clinical trials may either be interventional or observational clinical trials.
Interventional clinical trials involve giving a participant a particular treatment in accordance with a research plan. Usually, these
participants are compared to participants who receive no treatment or standard treatment.
Observational clinical trials involve giving a participant a particular treatment in accordance with clinical practice.
Clinical trials are usually conducted in humans in the following phases:
Phase 1 - Clinical trials that are usually conducted on a small number of healthy volunteers with close safety monitoring. The objective is to determine whether the drug is safe for use in humans and how the drug behaves in the human body.
Phase 2 Clinical trials that are conducted on a small number of patients with the illness being researched upon. The objective is to explore the therapeutic efficacy of the drug and to further evaluate its safety. A key objective of this phase is to determine the dose for phase 3 trial.
Phase 3 Clinical trials that are conducted on a larger population of patients. These clinical trials help to demonstrate or confirm the therapeutic efficacy of the drug and to collect more information that will allow the drug to be used safely. These studies are intended to provide an adequate basis for submission to regulatory authorities for product registration.
Phase 4 Clinical trials that are conducted to gather additional information about a drug's safety, efficacy, and optimal use. They are also sometimes known as post-marketing studies.
