Why Are Clinical Trials Important?
Clinical trials are research studies involving people. These studies are designed to answer specific scientific questions to find better ways to prevent, detect or treat diseases or to improve care for people with diseases. Trials are designed to help determine the safety and effectiveness of new treatments, and represent new possibilities for patients facing a medical illness. Between the time treatment therapies emerge from the laboratory and are routinely used by patients, investigational therapies go through the following phases:
Phase I involves a small number of people and is the first study on humans. The goal is to see if the treatment is safe, if it has harmful side effects, and how is best administered. If the results are positive, researchers move on to Phase II.
In Phase II, trials measure the new therapy's safety and effectiveness in fighting disease. Still, only a small number of participants take part in these studies. If benefit is demonstrated, it moves on to Phase III.
Phase III examines how the new therapy compares to standard treatments, the "benchmark" for measuring and evaluating new and improved possibilities in medical treatments. These trials involved hundreds of participants at different hospitals, cooperative groups and research centers.
Phase IV & V
In these phases a trial examines a therapy once it has been approved by the Food and Drug Administration (FDA) approved and the therapy is available to the public. Usually several hundred to several thousand participants take part in these studies. They assist in further evaluating the long-term safety and effectiveness of a new treatment.
There are also studies that are designed to improve comfort and quality-of-life for people who have been diagnosed with a disease such as cancer, heart disease or diabetes. These types of trials may study the impact of treatment or services on patients, their family members, or the healthcare providers caring for these individuals.
In addition, there are clinical trials, which include the collection of tissue or blood specimens that will be used for testing new technologies or therapies.
In all of these trials the objective is furthering the understanding a disease and its impact on patients. Many of today's most effective treatments in healthcare are based on previous study results. Because of progress made through clinical trials, many people are living longer.
Clinical trials are a critical part of the research process. Clinical trials translate basic scientific research results into better ways to prevent, diagnose, or treat disease. Clinical trials are the final step in a long research process.
The more people who participate in clinical trials, the faster critical research questions can be answered that will lead to better treatment and prevention options for all cancers. We will never know the true effectiveness of a treatment or a way to prevent specific diseases such as cancer, heart disease, or stroke unless more people are involved in clinical trials.
In the past, clinical trials were sometimes seen as the last resort for patients who had no other treatment choices. This is not true; there are many clinical trials for prevention of certain disease processes. We must also keep in mind clinical trials may provide us with the newest way to treat a disease that is not available any other way.
Once a new drug or intervention is proven safe and effective in a clinical trial, it may become the new standard of practice. Everything we can tell people about treatment options for their medical ailments today is based on the results of clinical trials. Members of the interested public can help speed up the research process.
It takes 14 years, on average, for an experimental drug to travel from laboratory to U.S. consumers. Often the longest part of the process is finding people to participate in each trial phase. With increase public awareness about clinical trials, more people may be willing to participate, and more professionals may refer people into appropriate trials. This awareness ultimately reduces the time it takes for researchers to enroll participants in trials and complete them, and speeds the movement of new drugs or treatments into standard care.