The Treatment Of Terminally Ill Patients

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Terminally ill patients should have access to potentially lifesaving experimental drugs. There are three ways to get access to these drugs. The Food and Drug Administration has a program called Expanded Access. Clinical trials throughout the drug development process are another way to gain access. Recently, some states have been passing “Right-to-Try Laws (Larner, par. 1-5). The purpose of clinical development is to bring new drugs and therapies to patients. These drugs and therapies are studied and researched to be used for humans. Clinical development is very expensive and time consuming. The process of discovering a new drug, to having it approved for patient use, is approximately twelve years. The average cost to complete this process …show more content…

1-5). The first step in developing a drug is pre-clinical testing. The experimental drug is tested in a laboratory and in animal studies. The drug has to meet safety standards and show potential for being a new drug. If this criterion is met, the drug moves on to the next phase. Phase 1 is concentrated on making sure the drug is safe to use on humans. This is the first time the experimental drug is used on people. Different measures of dosages of the drug are given to a small number of the volunteers. This allows the researchers to be able to measure the body’s response to the drug. The things they measure include how the drug is absorbed, its duration in the bloodstream, and what dosage levels are safe and well accepted by the body. If the experimental drug is deemed safe, it passes on to Phase 2 (Phases of Development, par. 6-7). Unlike Phase 1, Phase 2 focuses on the effectiveness of the drug. Clinical trials for this phase usually have several hundred participants; largely, these participants have the illness that the drug is supposed to treat. The information collected in these clinical trials includes the safety of the drug, the side effects, and the potential hazards. The most effective dosage is usually found in this stage. Researchers also find the most suitable delivery methods, for example tablets, extended release capsules, infusions, or injections. Phase 3 is testing the results of earlier trials

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