India is today poised as one of the favorable destination for conducting global clinical trials in terms of large patient populations, skilled manpower, cost effectiveness, favorable economic and IP environment etc. A clinical trial is a process of testing a medication for its safety and effectiveness, either in comparison to a placebo or an already existing treatment. Clinical trials are part of research, which leads to development of a new treatment. Any new treatment has to be cautiously evaluated through the several phrases of the trial before it can be used to treat people. No trial can be executed successfully without the voluntary participation of subjects. All the subjects are given a document called as Informed Consent Document, which mentions the purpose of the study, procedure, and the risk and benefit involved in the study. Before any trial procedures are started, this document needs to be signed voluntarily by the patient. The decision to participate or not, rests entirely upon the subject, and he / she can terminate his / her participation at any time, if not benefiting from the treatment. All trial procedures have to be executed according to the ICH- GCP guidelines; these are a set of standards, which are used internationally for the conduct of trials, ensuring the rights, safety and well being of the trial subjects.
All clinical trials are commonly divided into 4 phases. The drug will be approved for use in the general population if it passes through phase 1, 2 & 3.
In this phase a small group of healthy volunteers are selected. Here, the safety of the drug is monitored closely to determine its side effects.
Trials are done on a group of patients and are designed to assess the activity of the therapy. This phase is safer than phase 1 trials. Phase 2 trials are designed to study the efficacy.
Studies in this phase assess the value of the test drug in a larger group of patients against an approved drug or therapy.
Studies are undertaken by the sponsor company for competitive or other reasons (Example: the drug may not have been tested in certain population groups such as pregnant woman, or it could be tested for interaction with other drugs, etc). These trials involve the post-launch safety surveillance of a drug to detect long-term adverse effects over larger patient population.
The investigator needs to set up a good research unit, so that the trial is conducted smoothly and results obtained are of good quality. The set up requires good infrastructure facilities and appropriate human resources. More than 150 clinical trials are in progress at any given time in Ruby Hall Clinic.