Drug Trials

A drug trial takes a very long time usually it takes between 10 and 16 years after being discovered to being sold, and that’s only if it passes a rigorous trial process. There are around 6 testing stages; PRE-CLINICAL, PHASE I TRIALS, PHASE II TRIALS, PHASE III TRIALS, REVIEW & APPROVAL. The trials and study’s allow unknown questions to be asked and answered as well as to improve the effectiveness of the drug. Do improve effectiveness and safety double blind trials are carried out as well as certain age and health limits on volunteers.

Pre-Clinical: The new drug that a company wants to market is first tested in test tubes and on small animals before humans. If the drug is safe and effective in the animals then it may be approved for the next stage of testing. About 0.1% are approved for the next stage.

Phase I: The researchers will test the drug on about 20 to 100 healthy and sometimes unhealthy volunteers. This is done to work out what the effects are benefits of the drug are and how a patient would react to an increased dose. This stage last around 2-3 years, 70% o these trials go onto the next stage.

Phase II: This time the drug will be tested in a larger group of people, 100- 300 people. This is done to see if it is effective, evaluate its safety, short-term side effects and risks. The drug must show an large improvement in effectiveness or a reduce in cost or for diseases like brain cancer a smaller improvement to be approved. The study last 2 years and about 50% continue to the next stage.

Phase III: The drug is now tested in the community on several hundred to several thousand people. This allows the researchers to confirm its effectiveness, monitor side effects, compare it to other drugs, and collect safety information and the overall benefit-risk relationship. This last several years and about 70-90% of the drugs will go onto the next stage.

Review & Approval: This text stage involves the researchers preparing and evaluating the information before sending it off to a Drug approval department. In the drug is approved then the company receives a license to sell their new drug commercially. This process takes about 1 year

Double Blind Trial: A double blind trial is carried out so that there is less risk of bias affecting the results. During the trial neither the researchers nor volunteers know if they are in the test group or control group. The only people who know how is in which group are a third party. After the testing the researchers are then told who was in each group.

Safety: During a drug trial a doctor is responsible to the safety of the volunteers, if he/she believes the drug is poorly affecting the volunteers then the trial can be stopped. For safety reasons, many clinical trials of drugs are designed to exclude women of childbearing age, pregnant women, and/or women who become pregnant during the study. In some cases the male partners of these women are also excluded or required to take birth control measures