Clinical Trials Essay

1279 words - 6 pages

Every medical innovation starts with an idea or vision, and goes through several developmental stages, namely, basic research, translational research and clinical research before being able to market the treatment. (4) This treatment can be a drug, a medical device, a vaccine, a blood product or gene therapy. (3) The basic research is done in a laboratory, where cell function is studied, and it is determined under what conditions the treatment could cause cells to function more effectively. The treatment is then tested in animals to see the effect, and to test possible toxicity. Once the treatment has been named safe for use in animals, it can then be tested in humans. (4) Clinical research, ...view middle of the document...

(4) All this research leads towards improving medical knowledge, medical care and help with the direction of resources to the most effective treatments. (2)
The clinical trial will be sponsored and funded by a pharmaceutical company, a federal agency or an individual, and the sponsor will then decide on a location for the trial. Clinical trials usually take place at universities, medical centres, clinics, doctor’s rooms, hospitals. (1)
The clinical trial begins with a plan, known as a protocol. This is drawn up by a principal investigator, who will head up the trial, and this protocol will state what will happen during the trial as well as explanations of why it will happen. The protocol clearly states how many patients will be required, the eligibility criteria of the patients that will take part, the dosage of the treatment that the patient will receive, the tests that will be done on the patients and how often they will be done, the type of data that will be collected, and a detailed explanation of the respective treatment plan. The patients that take part in the trial have to be eligible, therefore fitting the traits required, these including age, gender, type and stage of disease or condition and previous treatment and health history. (3) The criteria are put in place to ensure that new treatments are tested on similar groups of people, thereby reducing variation, but not to the extent that the scientific reliability of the trial will be questioned. (1) They also act as a safety measure to ensure that patients participating in the trial will receive benefits that will outweigh the risks. (3) The criteria that permit a patient to participate are inclusion criteria, and those that do not permit a patient to participate are exclusion criteria. (4)
A clinical trial is conducted in 4 phases, each of which has a different purpose in helping to answer scientific questions. The phases can be seen in Figure 1 below. Phase 1 begins with the treatment being tested in a small group of 20-80 people, testing the safety of the treatment as well as determining a safe dosage and noting any side effects. The trial then moves on to Phase 2 in which the treatment is tested in a larger group of 100-300 people, in order to observe the effectiveness of the treatment and further test its safety. In Phase 3 the treatment is given to a group of 1000-3000 people, confirming the effectiveness of the drug as well as monitoring previously identified side effects, comparing it with existing treatments and collecting data for safe usage of the treatment. If a treatment successfully passes Phase 3, the Food and Drug Administration can then approve the product and...

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