August 6, 2012
Experimental Research Elements
In the United States the development of a new drug, for human consumption is a long and difficult process requiring many levels of testing. Mandated by the food and drug administration (FDA) the rigorous process of new drug development can consists of at least four phases. If the FDA approves the new drug to be safe and effective for humans, generally, from start to finish the entire process of new drug development, take an average of 12 years of experimental research costing the pharmaceutical company millions of dollars. Recently a pharmaceutical company wants to test a new sleep aid for humans, using a scenario like this can provide more specificity on exactly how the potentially new sleep aid goes from the laboratory to a consumer. In new drug development, researchers systematically use the experimental research placing emphasis on key elements--hypothesis, randomization, treatment group, control group, and measurement (University of Phoenix, Week Three Supplement, 2012). Each key element of experimental research corresponds to a specific phase in new drug development. Possibly the most important element is hypothesis testing that occurs in the pre-clinical research phases of new drug development. Hypothesis testing in the pre-clinical phase is necessary to support the claim made by the pharmaceutical to convince the FDA that the new sleep aid shows is effective and safe to test on humans (Simonoff, 2010). In this case, the hypothesis is that the new sleep aid is more effective in reducing the symptoms of insomnia. Using evidentiary support in pre-clinical trials of the new sleep aid did prove the claim of efficacy and that it is safe to test on humans in clinical trials. The next step in new drug development occur in three phases of clinical trials in which researcher’s further use experimentation to test the hypothesis of the sleep aide on human subjects. Critical...