Number of clinical trials in india 2010

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As the amount of streptomycin available from US was limited, it was ethically acceptable for the control subjects to be untreated by the drug—a statistician's dream. Another significant feature of the trial was the use of objective measures such as interpretation of x-rays by experts who were blinded to the patient's treatment assignment.

Sir Bradford Hill had formed his allocation ideas over several years with randomisation replacing alternation in order to better conceal the allocation schedule , but had only tried them out in disease prevention. Dr Hill instituted randomization — a new statistical process which has been described in detail in the landmark BMJ paper of After acceptance of a patient by the panel, and before admission to the streptomycin centre, the appropriate numbered envelope was opened at the central office; the card inside told if the patient was to be an S or a C case, and this information was then given to the medical officer of the centre.

Patients were not told before admission that they were to get special treatment. C patients did not know throughout their stay in hospital that they were control patients in a special study; they were in fact treated as they would have been in the past, the sole difference being that they had been admitted to the centre more rapidly than was normal. Usually they were not in the same wards as S patients, but the same regime was maintained. Sir Bradford Hill had been anxious that physicians would be unwilling to give up the doctrine of anecdotal experience.

However, the trial quickly became a model of design and implementation and gave a boost to Dr Hill's views and subsequent teaching, and resulted, after some years, in the present virtually universal use of randomised allocation in clinical trials.

The ethical framework for human subject protection has its origins in the ancient Hippocratic Oath, which specified a prime duty of a physician — to avoid harming the patient. However, this oath was not much respected in human experimentation and most advances in protection for human subjects have been a response to human abuses e.

World War II experiments. The first International Guidance on the ethics of medical research involving subjects — the Nuremberg Code was formulated in Although informed consent for participation in research was described in , the Nuremberg Code highlighted the essentiality of voluntariness of this consent.

In at Helsinki, the World Medical Association articulated general principles and specific guidelines on use of human subjects in medical research, known as the Helsinki Declaration. The Helsinki Declaration has been undergoing changes every few years the last one being in However, the use of placebo and post-trial access continue to be debatable issues. In particular, no one shall be subjected without his consent to medical or scientific treatment. Henry Beecher's study of abuses and the discovery of human exploitation of Tuskegee study in the s reinforced the call for tighter regulation of government funded human research.

In , International Conference on Harmonization published Good Clinical Practice, which has become the universal standard for ethical conduct of clinical trials.

After that, legislation progressively demanded greater accountability for marketing food and drugs and the need for testing drugs in clinical trials increased. The regulatory and ethical milieu will continue to evolve as new scientific disciplines and technologies become part of drug development.

India has recently been recognized as an attractive country for clinical trials. But the country's journey in clinical research field has a long history. India has a rich heritage of traditional medicine — Ayurveda. The classic ayurvedic texts contain detailed observations on diseases and in-depth guidance on remedies. It is likely that these descriptions are based on direct observations made by the ancient ayurveda experts. However, there is no recorded documentation in the ancient texts of any clinical experiments.

Hence, one has to fall back on current history of medical research in India. The major historic milestones of the Indian Council of Medical Research reflect, in many ways, the growth and development of medical research in the country over the last nine decades. Between , several projects on beriberi, malaria, kala azar and indigenous drugs were initiated.

Over next 60 years, ICMR established many national research centers in the fields of nutrition, tuberculosis, leprosy, viral disease, cholera, enteric disease, reproductive disorders, toxicology, cancer, traditional medicine, gas disaster, genetics, AIDS etc. Venkatachaliah held its first meeting on September 10, Several subcommittees were constituted to consider ethical issues in specific areas e. The committee released Ethical Guidelines for Biomedical Research on Human Participants in which were revised in Schedule Y of Drugs and Cosmetics Act came into force in and established the regulatory guidelines for clinical trial CT permission.

The schedule did force the industry to conduct Phase III clinical trials for registration of a new drug and supported growth of a predominantly generic Indian pharmaceutical industry. However, this schedule only permitted clinical trials at a phase lower than its global status.

This phase lag obstructed integration of India in global clinical development. The next major step has been revision of Schedule Y in Jan The earlier restrictions on number patients and centers in early phases stipulated in Schedule Y were removed allowing the sponsor company freedom to decide these in relation to protocol requirements.

This schedule stipulated GCP responsibilities of ethics committee EC , investigator and sponsor and suggested formats for critical documents e. These amendments in Schedule Y have been a major step forward in direction of GCP compliant trials and have provided the much-needed regulatory support to GCP guidelines. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured.

After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display. Forgot Password New Applicant. Keyword Search. Health Condition of trial participants is now coded as per ICD classification and must be chosen from the drop down list provided up to a maximum of 4 levels to the nearest disease category possible. Try the modernized ClinicalTrials.

Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms.

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