Medical research studies are vital to the health care system. Clinical drug development relies on these studies in order to test the safety and efficacy of new medications and treatment protocols. When a clinical study is conducted, researchers are able to determine whether experimental drugs or treatments have side effects and to what extent. It is in this way that new drugs and treatments become available on the market.
Phase 1 Clinical Trials
During a Phase 1 clinical trial, an experimental drug or treatment is initially tested on a small group of people. The size of the Phase 1 clinical trial group is usually 20 to 80 people. The primary purpose of this phase of the clinical trial is to evaluate whether the drug or treatment is safe. In addition to determining safety, the drug or treatment’s side effects, if any, are noted.
Phase II Clinical Trials
During a Phase II trial, the experimental drug or treatment is administered to 100 to 300 people. The purpose of this phase of the trial is to determine whether or not the drug or treatment is effective. This phase is also focused on determining whether or not the drug or treatment can be used safely.
Phase III Clinical Trials
During a Phase III trial, the experimental drug or treatment is administered to an even larger group of people. This usually ranges between 1,000 to 3,000 individuals. There are several purposes for this phase of the trial. First of all, the researchers want to confirm the drug or treatment’s effectiveness. Secondly, they want to monitor any side effects that may be occurring. Thirdly, they want to compare the drug or treatment with existing standard or equivalent drugs and/or treatments. Finally, the researchers want to collect further data and information to demonstrate that the drug or treatment can be safely used.
Phase IV Clinical Trials
Following the completion of a Phase IV clinical trial, the team involved will submit a New Drug Application for market approval. While 5,000 to 10,000 experimental drugs and treatments undergo research and development, only 250 of these will be tested in a pre-clinical trial setting. Given all of the experimental drugs and treatments that are the subject of study, just five will actually go through the clinical testing process. Out of these five, only one is usually approved by the Food and Drug Administration for market release.
Clinical Trial Outcomes and Chance
In order to determine whether or not a study’s results may be due to chance, the p-value is used. Since there may be a difference between the treatments being tested, it is essential to demonstrate that a drug or treatment protocol’s effectiveness is not due to other factors. When the p-value is less than 0.05, this is a significant finding. Basically, this demonstrates that there is less than a five percent likelihood that the study’s results were due to chance.
The Importance of Clinical Trials
If you’ve never participated in a clinical trial, you may want to consider doing so. A survey regarding clinical trials within the United States showed that just four percent of Americans have participated in this important type of research. This signifies that 96% of the population has not participated in a clinical trial.
It is interesting to note that 46% of the survey participants concurred that participating in clinical trials was valuable to the health care system. Furthermore, they concurred that participating in these types of trials was as valuable as donating blood.