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Clinical trials are medical research studies to test whether different treatments are safe and how well they work. Some trials involve healthy members of the public, and others involve patients who may be offered the option of taking part in a trial during their care and treatment.
Over the past decade, India has become an important destination for many international pharmaceutical companies looking to carry out clinical trials. “The pharmaceutical industry has had a long presence here, it is a well-oiled industry”. “India is unique for clinical trials and is cheap. The population is more genetically diverse. Availability of a well-established research infrastructure and plenty of experts make it a prime place to do clinical trials.”
Clinical trials cover a wide range of different types of research. For example, trials are often used to test new medicines or vaccines, but they can also be used to look at new combinations of existing medicines. They can also be used to test whether giving a treatment in a different way will make it more effective or reduce any side effects. Some trials are designed to try out ways to prevent a particular disease in people who have never had the disease, or to keep a disease from rebounding.
Many different types of Clinical Research Organization support clinical trials like pharmaceutical companies, charities etc. All trials, are checked and monitored in similar ways to make sure that the rights of participants are protected. Each trial also has a sponsor who is responsible for running the trial. The sponsor may be the organisation funding the trial or the institution hosting the research.
Many of these organisations involve patients to help decide what will be researched in the future. It is essential that research takes account of the needs and interests of the people it is trying to help. Specialists often know what needs to be found out about diagnosis and treatment, but patients and their families may think other aspects of care need further research.
Different types of Trials
Clinical trials are carried out in two stages - an ‘early stage’ and a ‘later stage’.
Early stage trials usually involve a small number of patients or healthy people. When psychological treatments or educational programmes are being tested, these early stage studies can be used to ‘fine tune’ the treatment before it is tested on a large group of people. For trials of medicines and other treatments, early stage studies are carried out on a small group of people to assess safety by looking for unwanted side effects.
Later stage clinical trials involve larger numbers of participants and are usually ‘randomised trials’.