Clinical trials have been important for the growth of scientific development, finding new drugs that work and even cures or effective treatments for a wide variety of conditions. Clinical trails have even been helpful for the people who partake in them, those who have exhausted many of the methods of traditional treatments and are looking for a miracle. While clinical trails do not always provide the miracle, some clinical trial patients have found a successful course of treatment in clinical trials.
However, there are a number of important considerations to undertake when undertaking a clinical trial. The first and one of the most important is, of course, that of consent. It is law that all members of any clinical trial must be willing participants and this rule is so important that is now has its own section in the American Psychological Association’s Ethical Code. In the case of children (considered to be anyone under the age of eighteen in the United States) used in clinical trials, a parent or guardian must provide that consent before the clinical trial is allowed to proceed.
These medical research studies are typically conducted in phases, some with different trial participants for each phase. Phase I is considered to be the beginning phase, and typically has a test group no smaller than twenty people but no larger than eighty people. This is the phase where scientists and researchers first test a treatment or drug. A phase 1 clinical trial is conducted with the purpose of identifying the safety of the drug as well as any side effects that manifest over the course of the trial.
The second part of a clinical study is called Phase II. During this phase, the experimental drug or treatment that was first tested in Phase I is now given to wider group of clinical trial participants. Now, up to three hundred participants are given the drug or the treatment. The purpose of this phase of any clinical trial is to continue to assess the safety of the experimental drug or treatment as well as begin to assess its effectiveness.
Phase III is the second to last stage of clinical trials and is typically conducted with as many as 3,000 trial participants. This phase of the clinical drug development trial is geared towards confirming effectiveness as well as monitoring any side effects that have occurred and comparing it to other courses of treatment. How to safely implement the drug or the treatment is also considered in this stage of the trial.
The fourth phase of a trial is the last phase, and once it is completed the team who worked on the trial submit it to the NDA, or New Drug Application, for approval. Only a small percentage of new drugs or treatments pass successfully through the NDA and make it to the stage of gaining FDA approval.
Clinical trials have increased in length since the late 1990s. They now last an average of nearly 800 days, whereas in 1999 they only lasted less than five hundred days.