Diseases: Testing New Drugs
Diseases: Testing New Drugs
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New drugs are continuously being developed and must undergo rigorous testing before reaching the public. This is to ensure they are safe and effective.
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Preclinical trials take place initially. These tests are conducted in a lab, usually on cells, tissues, or animals, to identify if the drug is effective and to predict any possible side effects.
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If preclinical testing is successful, clinical testing on humans begins. Clinical trials are split into three phases:
Phase 1: A small group of healthy volunteers are given the drug to reveal its potential side effects and to understand how it works within the human body.
Phase 2: The drug is tested on a larger group of volunteers who have the disease or ailment. This helps to establish its effectiveness and monitor side effects in a wider variety of people.
Phase 3: The drug is administered to an even larger group of patients. This is the crucial stage for observing rare side effects and ensuring it works as intended across the population.
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If the drug passes all three phases, it will be peer-reviewed by scientists, and if successful, will receive a licence allowing it to be prescribed by doctors.
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All clinical trials must be rigorously monitored to ensure ethical considerations are met. This includes informed consent, assessment of benefits and risks, confidentiality, and the right to withdraw at any time.
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Double-blind trials are often utilised - neither the doctor nor the patient knows whether they are receiving the real drug or a placebo. This helps to eliminate bias in the results.
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Post-licensing surveillance continues after the drug has been released to the market to identify any long-term effects or rare side effects not picked up in the initial testing stages.
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Thalidomide is an example of a tragedy when drug testing failed. Initially marketed as a morning sickness drug for pregnant women in the 1950s, it led to severe birth defects, showing the critical necessity of thorough drug testing processes.