Diabetes Type 2 Support Group
Type 2 Diabetes is a condition in which the body either does not produce enough insulin or does not make efficient use of it. Insulin is a hormone needed to convert food into glucose, a sugar that the body uses for energy. Without enough insulin, glucose can accumulate in the blood, and can cause serious health problems such as heart disease and strokes and organ damage...
All approved drugs go through such trials, Many fall at the 1st hurdle
Its interesting that people will take all kind of say Chinese herbs or native herbs which have not been tested a tall.
A case in point is where the herbs were grown in polluted soil containing mercury they were only tested in the UK by a customs officer official looking for banned drugs where the poison was found by accident maybe the amount was not life threatening
But who needs it
The Mechanisms of a Controlled Trial
Published: September 18, 2010
In the United States, the Food and Drug Administration must approve an experimental drug like PLX4032 before it can be marketed. The process involves several stages, including laboratory and animal studies; controlled clinical trials for safety and effectiveness; and F.D.A. review. The trials are in four phases:
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Josh Anderson for The New York Times
Related
New Drugs Stir Debate on Basic Rules of Clinical Trials (September 19, 2010)
Phase I, an initial study in a small group, establishes whether a treatment is safe and at what dosage.
Phase II, in a larger group, evaluates the effectiveness of the drug and determines common short-term side effects and risks.
Phase III expands the evaluation, usually through a controlled trial where the drug is tested against standard treatments to evaluate benefits and risks, differences in response rates, and toxicity. One group of participants gets the experimental drug, and the control group receives a placebo or standard treatment (in the trial for the melanoma drug PLX4032, the control was chemotherapy). Participants are randomly assigned to a treatment group.
In a typical blind study, neither patients nor researchers know which participants are receiving the experimental drug. The trial of PLX4032 was unblinded, meaning doctors told patients whether they were assigned to the control arm.
Phase IV takes place after the drug has been licensed and marketed, to determine optimal use.
SOURCE: ClinicalTrials.gov
Its interesting that people will take all kind of say Chinese herbs or native herbs which have not been tested a tall.
A case in point is where the herbs were grown in polluted soil containing mercury they were only tested in the UK by a customs officer official looking for banned drugs where the poison was found by accident maybe the amount was not life threatening
But who needs it
The Mechanisms of a Controlled Trial
Published: September 18, 2010
In the United States, the Food and Drug Administration must approve an experimental drug like PLX4032 before it can be marketed. The process involves several stages, including laboratory and animal studies; controlled clinical trials for safety and effectiveness; and F.D.A. review. The trials are in four phases:
Enlarge This Image
Josh Anderson for The New York Times
Related
New Drugs Stir Debate on Basic Rules of Clinical Trials (September 19, 2010)
Phase I, an initial study in a small group, establishes whether a treatment is safe and at what dosage.
Phase II, in a larger group, evaluates the effectiveness of the drug and determines common short-term side effects and risks.
Phase III expands the evaluation, usually through a controlled trial where the drug is tested against standard treatments to evaluate benefits and risks, differences in response rates, and toxicity. One group of participants gets the experimental drug, and the control group receives a placebo or standard treatment (in the trial for the melanoma drug PLX4032, the control was chemotherapy). Participants are randomly assigned to a treatment group.
In a typical blind study, neither patients nor researchers know which participants are receiving the experimental drug. The trial of PLX4032 was unblinded, meaning doctors told patients whether they were assigned to the control arm.
Phase IV takes place after the drug has been licensed and marketed, to determine optimal use.
SOURCE: ClinicalTrials.gov
for instance metformin is no longer trailed because its so established now. but is still trialled in combination with other drugs