How Clinical Trials Help Advance the Medical Mission
Clinical trials help to advance medical research studies by developing new drugs and treatments. Clinical trials help to increase the overall wellbeing of the populations and to advance medical progress. It is of the greatest importance that clinics trials should be arrived out in a safe and ethical manner. Every stage of the process, from phase 1 clinical trials to final approvals for marketing new drugs and treatments, is covered by strict ethical guidelines.
Clinical trials help advance medical progress
Clinical trials help to develop new medications and treatments in different therapeutic areas like cardiology, endocrinology, neurology, and gastroenterology. There are four phases of clinical trials. Only a very small percentage of new drugs make it all the way from phase I clinical trials to final FDA approval for the drug to go on the market.
Each year, some five to ten thousand new drugs enter the research and development process. Of these, only 250 go on to preclinical trial testing. These are narrowed down to five that actually enter clinical trials. Only one of these makes it all the way to final FDA approval and clearance to go on the market.
Clinical trials are carefully governed
The medical and ethical aspects of drug testing are carefully monitored all the way, beginning with phase 1 clinical trials. For instance, the length of time for clinical trials of new drugs and treatments has been increasing over the years. While in 1999, a clinical trial typically lasted for 460 days, by 2005 the length of clinical trials had increased to 780 days.
Clinical trial facilities and procedures are vetted by Institutional Review Boards, the trial sponsors and the FDA. Any violations can result in citations or recommendations for remedial action. Ethical standards are carefully maintained and monitored as well.
Phases of clinical drug development
There are four phases of clinical drug trials. Phase 1 clinical trials test new drugs or treatments on small groups of 20 to 80 people. At this stage, the focus is on determining the safety of the new drug or treatment and on identifying side effects, if any. In phase II, the drug or treatment is tested on larger groups of one to three hundred. The focus now is on efficacy and safety.
Phase III expands the group of subjects to one to two thousand. The goal is test the effectiveness of the new drug of treatment and to continue to monitor side effects. At this stage it is also compared it with existing standard or similar treatments. Information relevant to safe usage is also collected. Phase IV is the final stage and follows FDA approval for marketing, it tracks long terms use and effects of the drug or treatment.
Clinical study helps to advance the medical mission by testing new drugs and treatments. Beginning with phase I clinical trials, the entire process is carefully monitored in order to maintain medical and ethical standards.