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Companies conducting clinical trials in India often do so through a contract research organization. [39] Since the 2000s there has been recognition that India is an attractive place to grow an industry of drug research. [39] A 2008 report described the entry of multinational companies into India for clinical trials research as a frenzy. [40]
The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results. [22] Trials can be quite costly, depending on a number of factors.
Any company seeking approval to do clinical trials has to report the risks and benefits to patients for the research. [5] As a result of the ruling in 2014 India published new requirements for clinical trials. [6] The Supreme Court reprimanded an organization for not compensating victims who were injured. [7]
The Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest and largest medical research bodies in the world. The ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health and Family Welfare.
SmithKlineBeecham, known since 2000 as GlaxoSmithKline, conducted a clinical trial from 1994 to 1997 in 12 psychiatric centers in North America to study the efficacy of paroxetine (Paxil, Seroxat), an anti-depressant, on teenagers. The trial data suggested that the drug was not efficacious and that the paroxetine group were more likely to think ...
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The CTRI requests all the information which the World Health Organization recommends for clinical trial registries. [8] Additionally, the CTRI collects information specific to the circumstances of India, including the address of the principal investigator, the name of the ethics committee overseeing the trial and confirmation of their government registration; proof of permission from the Drugs ...
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