Essay paper #1Ebola Clinical TrialsClinical trialsClinical 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 speci ...view middle of the document...
With these results are possible to establish a preliminary evolution of the security and the pharmacokinetic profile. Phase II clinical trials, also called as therapeutic pilot study, evaluates the drug or therapeutic intervention in a small group of 100 to 200 patients affect to a determinate disease or pathology condition to determine its efficacy and confirm the security. Phase III studies investigate the efficacy of the biomedical or behavioral intervention in large groups of at least 800 people through internationals studies, of large scale, in multiples centers, with different population of patients. The objective of this phase is to evaluate the risk/benefit in short and large time of the medicine or therapy by analyzing of the type and profile of the adverse reactions more frequents, such as special characters of the medicament and/or medicinal specialties, for example the relevant clinical interactions, the main factors that modify the effect of the medicines like age, healthy historic and others. Moreover, it is the phase where the therapeutic profile are established, so it can be analyzed the indications, dosage, administration route, contraindications and side effects. The last phase of clinical trials is the phase IV where studies are conducted after the intervention has been approved for commercialization. These studies are designed to observer effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use. Clinical trials can vary in size, and can involve a single research entity in one country or multiple entities in multiple countries. Elders are frequently barred from trials because their greater health problems and drug use complicate data analysis. Women, children and people with unrelated medical conditions are also frequently excluded. Clinical traits are divided in observational studies and randomized controlled trails. Observational studies observe correlations between the treatment experienced by participants and their health status. A randomized controlled trial can provide persuasive evidence that the study treatment causes an effect on human health. Nowadays, some Phase 2 and most Phase 3 drug trials are designed as randomized, double-blind, and placebo-controlled. Randomized stand for studies where the subject is randomly assigned to receive either the study treatment or a placebo. Double blind is when neither the researches nor the patients know which treatment they are receiving. Placebo controlled the use of a fake treatment that allows the researchers to isolate the effect of the study treatment from the placebo effect. A complete series of trials may cost hundreds of millions of dollars. The encumbrance of paying is usually accepted by the sponsor, which may be a governmental organization or a pharmaceutical, biotechnology or medical device company. When the required support exceeds the sponsor's capacity, the trial may...
