Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute - Medical Research Department (KDAH-MRD) has been constituted in the year 2009.
The Research Mission of KDAH-MRD is to undertake and promote excellence in clinical research and to foster and support patient care and treatment. At KDAH-MRD, Pharma-sponsored, Government- sponsored, Investigator-initiated and Academic research projects provide the foundation for the research activities. These projects are complemented by large organizational projects, population-based epidemiologic studies, community-based intervention programs, multicenter controlled clinical trials, and research training programs.Special features of KDAH-MRD:
Clinical studies helps to bridge research and patient care by evaluating therapies, drugs and diagnostic tools to give way to discoveries that might be of benefit to the human patients in future.
Clinical trials are used to test the safety and effectiveness of drugs and devices. Usually, they are sponsored by pharmaceutical companies and are conducted by research teams that include doctors and other medical professionals. Clinical trials are typically conducted in four phases:
- Phase I is when generally healthy people are given the medication to test if the ingestion of the pill or treatment will have no adverse and/or toxicological effect and that it is absolutely safe to be used in human patients.
- Phases II and III involves deeper evaluation regarding the safety, effectiveness, and dosage of the medication. It’s after these stages that the country drug regulator would approve the drug or device.
- Phase IV examines and conducted to collect more information for previously approved treatments.
All of the phases in clinical trials are governed by strict protocols, and are overseen by many regulatory bodies, from the Drug Controller General of India to Institutional Ethics Committee (IEC). IECs are a group of independent medical experts, ethicists, as well as lay person. Researchers periodically report to the IEC regarding entire conduct of the study which includes the tests involved in the study, the results recorded and even the side effects reported. According to the recent regulations, IEC is accreditated with NABH. (National Accreditation Board for Hospitals)
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