Have you ever wondered what clinical trials are and how they work? Here?s all you need to know about this important step in the development of new medications, medical devices, or treatment strategies:
What Are Clinical Trials?
Most basically, a clinical study helps researchers decide if some kind of medical treatment is safe for people. It might be a clinical drug development trial, or a test of a new treatment or medical device. Before something gets to the clinical trial stage, a lot of prior research will have taken place so that there is no known reason to believe the treatment, medication, or device could be harmful to people.
Are They Safe?
The reality is that very few treatments for medical problems can be guaranteed to be 100% safe for all people at all times. Clinical trials are more dangerous than established procedures by definition. Because of the nature of medical research studies, they require informed consent, which is so important that it is covered in section 8.02 of the 9th revision of the American Psychological Association?s Ethical Code. If medical research studies need children to participate, the children?s parents or guardians must give consent.
How Do They Work?
First, researchers establish initial parameters, such as how many patients are needed, how long the study will last, what tests or treatments will be administered, and how often. To avoid bias, the participants are divided into groups at random and the treatments are masked; that is, neither the researchers nor the participants know who is receiving the actual treatment and who is receiving a placebo–which is an inactive medication or treatment that is indistinguishable from the real thing.
What are Phase Trials All About>
In a Phase 1 clinical trial, the experimental treatment is given to just a small group of people. The main purpose of this phase is to minimize risk by testing that a treatment is safe and evaluating any side effects. In Phase II, a much larger group of people will be involved, as many as 3,000, still primarily to see if the treatment seems effective and to further test the safety of the treatment. In Phase III, researchers will confirm the treatment is doing something, monitor side effects, and compare it with other treatments. After Phase IV, researchers can submit a New Drug Application (NDA) to get approval from the FDA to put their treatment on the market.
How Many Drugs Go Through Trials?
All new drugs must go through clinical trials. About 5,000 to 10,000 drugs are researched every year in the United States, and of those, only 250 actually make it to the pre-clinical trial testing period. Out of that 250, only about five will end up in clinical trials, and only one will eventually pass all the trials and enter the market.
How Useful Are These Trials, Really?
Clinical trials are very useful, in fact 46% of involved people polled said that taking part in a clinical trial is as valuable to our health care system as donating blood. Without clinical trials, there could be no guarantee that a treatment will be safe and effective.
Clinical trials are funded by pharmaceutical companies, medical device manufacturers, foundations, and government organizations, to name just a few. These essential components of our health care system improve and advance the level of health care that doctors and researchers can offer to us all.