An Overview of Clinical Trials and Their Importance Within the Health Care System
Clinical trials are essential in order to determine whether or not a new drug or treatment protocol will be available on the market. While there are 5,000 to 10,000 drugs that enter the research and development phase every year, just 250 of these will reach pre-clinical trial testing. Following this phase, only five drugs are likely to be used for clinical trial testing, and following this extensive process, just one is likely to be approved by the Food and Drug Administration.
Opinion Survey Results Regarding United States Clinical Trials
A survey on United States clinical trials was recently conducted. The results showed that 96% of the participants had never been part of a clinical trial. It’s interesting to note, however, that 46% of the participants “somewhat agreed” that taking part in these trials was valuable to the health care system. More specifically, they somewhat agreed that participating was as valuable as donating blood.
The Importance of Informed Consent for Clinical Trials
One of the concerns that some people may have is the issue of informed consent. They may, for example, be reluctant to participate in a clinical trial because they aren’t aware of this ethical code. Given the importance of informed consent with clinical trials, the American Psychological Association’s Ethical Code has an entire section dedicated to this. It can be located in section 8.02 of the code’s ninth revision.
The Four Phases of a Clinical Trial
Based on the results from each phase of a clinical trial, researchers will determine whether or not an experimental drug or treatment protocol will advance to the next phase. In a Phase 1 clinical trial, an experimental drug or treatment will be administered for the first time to a group of 20 to 80 individuals. During a Phase 1 clinical trial, the primary goals are to evaluate whether the drug or treatment is safe and if there are any side effects. If side effects are discovered during a Phase 1 clinical trial, these will be identified and noted.
While there may be some exceptions due to the findings of a Phase 1 clinical trial, a Phase II trial will usually follow. During this phase, the experimental drug or treatment will be administered to a group of 100 to 300 individuals. The primary goals of this phase are to determine whether or not the drug or treatment is effective and to evaluate its safety in more detail.
During Phase III trials, the experimental drug or treatment will be administered to groups of 1,000 to 3,000 individuals. In addition to confirming the drug or treatment’s effectiveness, any side effects will be monitored. The drug or treatment will also be compared to standard or equivalent treatments at this time. Researchers will continue to collect information on the safe use of the experimental drug or treatment.
Once the previous trials have been completed, the experimental drug or treatment will enter Phase IV of the clinical trial. Upon completion of this phase, the clinical trial team will submit a New Drug Application to the Food and Drug Administration for approval. As previously mentioned, just one drug will usually receive approval and be placed on the market.
Learn More About Participating in a Clinical Study
In addition to all of the above, you may be interested to know that clinical trials take place over a longer period of time than they did in the past. In 1999, for example, one of these trials would last 460 days. Just six years later in 2005, a clinical trial lasted 780 days. This is because clinical drug development does require time to ensure that it is effective and safe.
Medical research studies are vital to the development of new drugs and treatments for a variety of illnesses and conditions. Given this, you may realize that you would like to learn more about studies being conducted in your area. You can contact your primary care physician or specialist to find out if they know of any studies for which you may qualify. Participating in a clinical trial may make a significant difference in your life as well as the lives of others.