New medicines must be approved as safe, efficacious and of good
quality before they can be prescribed. But authors of two recent
articles in the British Medical Journal argue that governments should introduce new criteria to the approval process.
In Australia, ensuring the safety and efficacy of medicines is the responsibility of the Therapeutic Goods Administration (TGA). A drug is efficacious if it cures or alleviates the disease or condition experienced by the patient.
Pharmaceutical companies undertake clinical trials to determine whether a potential new drug meets the requirements for market authorisation. The final stage of the clinical trial process entails administering the drug to a large number of people. The effect on these patients is then compared to a control group given a placebo.
This type of trial is designed to establish whether it’s better for the patient to take the drug in question than not to do so. But it’s not possible in this type of trial to determine whether the new drug is better (and, if so, how much better) than already available medicines (or other therapies).
Read more: http://theconversation.edu.au/how-to-get-drug-companies-to-put-needs-before-profits-8730
In Australia, ensuring the safety and efficacy of medicines is the responsibility of the Therapeutic Goods Administration (TGA). A drug is efficacious if it cures or alleviates the disease or condition experienced by the patient.
Pharmaceutical companies undertake clinical trials to determine whether a potential new drug meets the requirements for market authorisation. The final stage of the clinical trial process entails administering the drug to a large number of people. The effect on these patients is then compared to a control group given a placebo.
This type of trial is designed to establish whether it’s better for the patient to take the drug in question than not to do so. But it’s not possible in this type of trial to determine whether the new drug is better (and, if so, how much better) than already available medicines (or other therapies).
Read more: http://theconversation.edu.au/how-to-get-drug-companies-to-put-needs-before-profits-8730
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