Ebola clinical trials

Essay by emelybaldiCollege, UndergraduateA, November 2014

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Ebola Clinical Trials

Clinical trials

Clinical trials are research studies realized in humans to response specific questions about biomedical or behavioral interventions on human subjects. These studies evaluating the safety and efficacy of new drugs, vaccines or treatments. Only after a deep study and lots of information, the new intervention is approved to be used as an alternative for a specific disease. This approval are realized by health authorities and ethics committees in the country where approval of the therapy is sought. Clinical trials frequently involve healthy interventions with no pre-existing medical conditions but sometimes relate to patients with specific health conditions who seek otherwise unavailable treatments. Clinical trials might proceed through five phases that are pilot, phase I, phase II, phase III, and phase IV. The pilot experiment are conducted to gain a better understand of the pharmacologic activities and safety of the product in investigation.

Before the pilot, the new molecules are experimented in vitro tests. After that, the pilot is realized in animals. More than 90% of the substances studied in this phase are eliminated due to be too toxic in humans or don't show enough pharmacological activity. Usually pilot experiments are conducted to gain insights for design of the clinical trial to follow. The substances with specific pharmacological activity and a toxicity profile acceptable continue to be analyzed in phase I. The phase I clinical trials study is the first group of study in humans. It is compost of a small group of 20 to 100 healthy volunteers who receive financial incentives. During dosing periods, study subjects typically remain under supervision for one to 40 nights. The purpose of the phase I is to examine the tolerance of the component in healthy people. This phase analyze the highest tolerable dosage, the less effective...