Before a new treatment reaches patients, it is studied step by step — each phase answering a different question about safety and how well it works. Here is what happens at every stage.
Each phase builds on the one before. The number of participants grows as confidence in the treatment’s safety increases, and monitoring continues even after the treatment is approved.
Tests safety, how the treatment works in the body, the safe dose range, and identifies side effects in a small group of participants.
Evaluates how well the treatment works and continues to monitor safety in a larger group.
Confirms effectiveness, monitors side effects, and compares the new treatment with standard treatments in large populations.
Conducted after approval to collect long-term safety, benefits, risks, and optimal use in real-world settings.
Whichever phase you are invited to join, the same protections apply at KG Hospital.
The study team explains the trial, its possible benefits and risks before you decide. Taking part is your choice, and consent materials are available in English and Tamil.
Every study is reviewed and continuously overseen by an Ethics Committee and follows ICH-GCP E6(R3) and the NDCT Rules, 2019.
Dedicated emergency and critical care facilities are available at the hospital, and adverse events are managed and reported as required.
Download this guide, read about your rights as a participant, or speak with our Clinical Research Centre team.
Prepared by the Clinical Research Centre, KG Hospital, for general information. It does not replace the study-specific information and consent discussion provided by the research team.