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Clinical observation. Much of the investigative clinical field work undertaken in the present day requires only relatively simple laboratory facilities because it is observational rather than experimental in character. A feature of much contemporary medical research is that it requires the collaboration of a number of persons, perhaps not all of them doctors. Despite the advancing technology, there is much to be learned simply from the observation and analysis of the natural history of disease processes as they begin to affect patients, pursue their course, and end, either in their resolution or by the death of the patient. Such studies may be suitably undertaken by physicians working in their offices who are in a better position than doctors working only in hospitals to observe the whole course of an illness. Disease rarely begins in a hospital and usually does not end there. It is notable, however, that observational research is subject to many limitations and pitfalls of interpretation, even when it is carefully planned and meticulously carried out.
Drug research. The administration of any medicament, especially a new drug, to a patient is fundamentally an experiment: so is a surgical operation, particularly if it involves a modification to an established technique or a completely new procedure. Concern for the patient, careful observation, accurate recording, and a detached mind are the keys to this kind of investigation, as indeed to all forms of clinical study. Because patients are individuals reacting to a situation in their own different ways, the data obtained in groups of patients may well require statistical analysis for their evaluation and validation.
One of the striking characteristics in the medical field in the 20th century has been the development of new drugs, usually by pharmaceutical companies. Until the end of the 19th century, the discovery of new drugs was largely a matter of chance. It was in that period that Paul Ehrlich, the German scientist, began to lay down the principles for modern pharmaceutical research that made possible the development of a vast array of safe and effective drugs. Such benefits, however, bring with them their own disadvantages: it is estimated that as many as 30 percent of patients in, or admitted to, hospitals suffer from the adverse effect of drugs prescribed by a physician for their treatment. Sometimes it is extremely difficult to determine whether a drug has been responsible for some disorder. An example of the difficulty is provided-by the thalidomide disaster between 1959 and 1962. Only after numerous deformed babies had been born throughout the world did it become clear that thalidomide taken by the mother as a sedative had been responsible.
In hospitals where clinical research is carried out, ethical committees often consider each research project. If the committee believes that the risks are not justified, the project is rejected.
After a potentially useful chemical compound has been identified in the laboratory, it is extensively tested in animals, usually for a period of months or even years. Few drugs make it beyond this point. If the tests are satisfactory, the decision may be made for testing the drug in humans. It is this activity that forms the basis of much clinical research. In most countries the first step is the study of its effects in a small number of health volunteers. The response, effect on metabolism, and possible toxicity are carefully monitored and have to be completely satisfactory before the drug can be passed for further studies, namely with patients who have the disorder for which the drug is to be used. Tests are administered at first to a limited number of these patients to determine effectiveness, proper dosage, and possible adverse reactions. These searching studies are scrupulously controlled under stringent conditions. Larger groups of patients are subsequently involved to gain a wider sampling of the information. Finally, a full-scale clinical trial is set up. If the regulatory authority is satisfied about the drug's quality, safely, and efficacy. it receives a license to be produced. As the drug becomes more widely used, it eventually finds its proper place in therapeutic practice, a process that may take years.
Реферат опубликован: 11/11/2009