What are ‘clinical research’
Clinical trials are research volunteers to assess the safety and effectiveness of medical treatment.
Breaking down the ‘clinical studies’
Clinical trials evaluate drugs, devices, treatments or changes in behavior to see if they are helpful or harmful and if they are more effective, less effective or as effective as existing treatments or when compared with placebo. Drugs usually undergo three phases of clinical trials. The first phase of testing supply of the drug, dosage and safety for a small group of people. The second stage uses more of the test group. Most of the drugs are not in one of these phases, but if they reach phase 3, they were tested on an even larger group and compared to placebo or currently accepted treatment. Only about 5% of drugs pass all three phases of clinical trials, and not approved for sale. There are several types of clinical trials. One trial no comparison group. A randomized, controlled study of two groups of patients who were randomized to receive either treatment or placebo. If the trial is double blind, neither the patients nor the doctors know which group is which as long as the investigation is not over. This type of study helps to get rid of bias. The knowledge gained in a clinical study to treat, diagnose or prevent medical problems.
The process of approval of the drug
Statistical analysis is a key component of outcome evaluation in clinical trials to determine whether the treatment is effective or the results were rather as a result of chance. Despite rigorous testing, it can be difficult to determine the effectiveness of the drug. During clinical trials prove that the drug works or does not work, they do not necessarily indicate causes. Another shortcoming of clinical studies is that subjects may be healthier than patients who used the treatment being tested.
New drug application (NDA) is the final formal step a drug sponsor, which involves application to the food and drug administration USA (FDA), to obtain the approval required to market a new drug in the United States to disclose is a comprehensive document with 15 sections, which includes data collection and analysis for research on animals and humans, drug pharmacology, toxicology and dosage, and process of its production. As soon as the drug reaches the NDA stage, the probability of obtaining FDA approval and sold in the United States exceeds 80 percent. Filing of the NDA, as a rule, does not lead to a significant increase in the value of shares of a public company-sponsor, since most of the stock’s appreciation is likely as the drug has passed through the successive stages of the previous clinical trials.