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The development of a drug that can be consumed by humans to cure a disease goes through several stages of animal and human testing before it is commercially launched. The tests that a new drug is subjected to are known as drug trials. Such tests are also termed as clinical trials when they are conducted to generate data so as to discover or verify the clinical and pharmacological profile or adverse effects of a new drug on humans. Such tests are necessary to establish the safety and efficacy of a new drug before its introduction in the market for human use. The new drug is first tested on animals wherein its efficacy, side-effects are observed in animals along with an estimation of drug dose. In later stages when the data collected by animal trials looks promising, the drug is tested on humans.
Bioethics
The trial of new drugs is essential to promote health services as they have the potential to improve the quality and lifespan of patients. The clinical drug trials on humans need to be performed in an ethical manner wherein the safety of the subject has been apprised of the consequences prior to the trial, his consent has been taken in writing and the test is performed as per international standards mentioned in International Conference of Harmonization – Good Clinical Practices Guidelines (ICH-GCP). It is also mandatory to ensure that the human subject clearly understand the repercussions of his decision of being used as a specimen in the clinical drug trial and understands clearly the risks of injury or death.
The person or institution who is preparing the clinical drug trial of a new therapy in humans must specify thoroughly the specific aims, problems and risks or benefits of the therapy. He must also pen down the reasons for choosing specific options and that the reasons for their being scientifically sound and ethically justified.
Good clinical practice (GCP)
It is essential to ensure the rights, safety, well-being, and confidentiality of trial participants. The data collected by the conduct of clinical drug trials needs to be protected and presented in a just and honest manner at the time of filing patent.
The Four Phases of Clinical Trial.
Clinical trials of drugs developed in India have to undergo all four phases of trials.
Phase I or clinical pharmacology trials or “first in man” study
This is the first time where the new drug is administered to a small number, a minimum of 2 healthy, informed volunteers for each dose under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient's body and behaves in the predicted way.
Phase II or exploratory trials
During this phase, the medicine is administered to a group of approximately 10-12 informed patients in 3 to 4 centers to determine its effect and also to check for any unacceptable side effects.
Phase III or confirmatory trials
Purpose is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate. In this phase, the group is between 1000-3000 subjects. If the results are favorable, the data is presented to the licensing authorities for a commercial license to market the drug for use by the patient population for the specified and approved indication.
Phase IV trials or post-marketing phase
It is the phase of surveillance after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.
The factors that make India a favoured destination for clinical trials The racial diversity in India provides a wide genetic pool which helps to test the drug’s effectiveness across a wide range of genes. Secondly Indians are ‘treatment naïve’, which means that people are less exposed to medicines as in developed countries. Thirdly, rampant poverty and illiteracy in India forces people who are unable to afford treatment to accept test of new drugs. Furthermore factors like low cost, large number of people with a range of illnesses, availability of trained human power and infrastructure, good patient compliance etc to a large extent provide congenial environment for clinical trials.
Legal framework
All clinical trials in India need to follow the ICMR guidelines. There is also online Clinical Trial Registry of India (CTRI) under the ICMR, which is responsible for creating a database of prospective clinical trials. The data and reports of these clinical trials and their status are made available to the public by ICMR when the new drug is made commercial.
Clinical trials in India are subject to Drugs and Cosmetics Act 1940 which was amended in 2005. It deals with regulations relating to clinical trial requirements for the import, manufacture and obtaining marketing approval for a new drug in India through Drugs Controller General of India.
Other legislations include Medical Council of India Act (1956), Central Council for Indian Medicine Act (1970), Guidelines for Exchange of Biological Material Order (1997) and Right to Information Act (2005).
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