A Guide to Clinical Research Trials
Clinical research trials are conducted in order to establish the safety and effectiveness of experimental new treatments and medical procedures. Research volunteers help clinical coordinators gather the data they need to accurately assess the drugs potential. Clinical studies on people only commence after the experimental treatment has passed through preclinical testing.
They are mainly used to research new medications, but they can also look at new dosage amounts or using existing medications as treatment for a different ailment. Clinical research trials are regulated by government agencies and must be approved before they begin.
Two Important Questions Answered During Clinical Trials
In general, clinical research trials start with a small group of volunteers and as the research advances the number of participants increases. It is important to remember that a clinical trial has been designed to help answer two very important questions:
- Will this new drug or procedure work for a patient? While the team of clinical research coordinators are working to answer this question, they will be considering several aspects of this issue. The new drug should not only work for people, but it should also provide a greater benefit to patients than what is already out there. Investigators are often looking to develop something that will work for people who haven’t had any success with more traditional methods of treatment.
- Will the new procedure or medication be safe for long-term usage? If you are living with a chronic illness like cancer, then you know that contemporary treatments all come with a list of side effects. When conducting a clinical trial, the research team is looking to weigh the potential benefits of the new drug against any recorded side effects.
Should You Participate?
The research team conducting the clinical trial doesn’t know how things will turn out– that is the entire purpose for conducting them in the first place. However, it is this same uncertainty that makes some people wary to take part in a research study. It’s important to understand that as a clinical trial volunteer, there are potential risks and benefits involved.
Did you know that countless lives have been saved because of the people who decided to take part in a clinical trial? The most effective treatments we have for diseases ranging from rheumatoid arthritis to breast cancer are the result of many years worth of extensive research studies on volunteers.
Clinical trials play a very important role in our modern society, but participation isn’t something that will work for everyone. It’s a personal decision that is highly dependent on the individual’s situation. You should consider discussing your options with your primary doctor before deciding to enroll in a study, especially if you are being treated for a chronic illness.
More Notable Facts about Clinical Trials
A sponsor usually covers the cost of clinical research trials. A sponsor can be a government agency, a private organization or a pharmaceutical company. Children and the elderly are generally excluded from clinical research studies.
Children are excluded mainly for ethical reasons and the elderly because they often have various health issues that can make it difficult to get accurate data.
There are several types of clinical research trials. These include prevention, screening, diagnostic, treatment, and quality of life. Each trial is designed according to its goals and a clinical trial protocol is put together. The clinical trial protocol outlines exactly how the clinical research trial is to be conducted.
The majority of clinical research trials are designed as comparison trials. This means that they compare a new treatment to an existing treatment. In some cases the comparison is to a placebo.
It is then decided which subjects will receive which treatment. In many cases this is randomized, meaning the subjects are chosen at random. In a “blind” clinical trial the subjects are not told which treatment they will be receiving. In a “double blind” clinical trial neither the subjects nor the researchers know who is receiving which treatment. Clinical research trials occur in four main phases known as Phase I – Phase IV.