What is clinical trials?
At the height of entry of any new drug into the market, the pharmaceutical companies get the most fanfare. Least emphasis is given to study participants who took all the risks to participate in the clinical trials. At Tripha, the study participants are our heroes. They are the reason that a life will be saved because of their voluntary and selfless act of participation in clinical trials.
Clinical trials were not popular until in the middle of 20th century. Before then it was difficult to know the efficacy of new treatment in a large population or to know which medication worked better than the other. Because of the initial risk involved in introducing a new medication in the population, the Food and Drug Administration (FDA) have set certain step and guidelines a drugs must go through before they are approved. This include, verifiable data from pre-clinical studies in animals, early toxicology studies through all phases of clinical trials up to post market drug surveillance.
Every clinical trial is designed to answer specific questions and predict an outcome of an investigational drug or device. These trials, therefore, follow certain protocol and rigorous guidelines established by federal government departments such as FDA and NIH. These guidelines ensure the safety and effectiveness of every trial. The analysis of risks involved begins with well designed animal studies before it can be tried in human populations. Most of the human trials have impeccable safety records.