What is a Clinical Trial?
In medical research, a clinical trial is an organized study conducted in people with a disease or condition to answer specific questions about a new treatment or a new way of using a known treatment. Each study tries to increase medical knowledge and to find new and better ways to help patients. Besides studying new drugs, clinical trials study new combinations of drugs already used in treatment, new ways of giving treatment, and how changes in lifestyle can help patients or prevent diseases from occurring. Other clinical trials compare the best known standard therapy with a newer therapy to see if one produces more cures and causes fewer side effects than the other.
Why are Clinical Trials important?
Clinical trials are designed to help us find out how to give a new treatment safely and effectively to people. Each patient who participates in a clinical trial provides information on the effectiveness and risks of the new treatment. Advances in medicine and science are the result of new ideas and approaches developed through research. The new treatments must prove to be safe and effective in scientific studies with a certain number of patients before they can be made available to all patients.
Phases for a Clinical Trial
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps called phases. Clinical trials are usually classified into one of three phases.
Questions you should ask your Research Team
Each clinical trial is unique, with its own potential benefits and risks. Before you decide to take part in a clinical trial, make sure you have answers to the following questions:
- Why is this study being done?
- What is likely to happen in my case if I decide to take part or decide not to take part in the study?
- What are my other options (standard treatments, other studies)? What are their advantages and disadvantages?
- How much experience do you have with this particular treatment? With clinical trials in general?
- What were the results in previous studies of this treatment? How likely are they to apply to me?
- What kinds of treatments and tests would I need to have on this study? How often are they done?
- Will this require an extra time or travel commitment on my part?
- How could the study affect my daily life?
- What side effects might I expect from the study? (Remember that there can also be side effects from standard treatments and from the disease itself.)
- Will I have to be in the hospital for any parts of the study? If so, how often and for how long?
- Will I still be seeing my regular doctor?
- Will I have any costs? Will any of the treatment be free? Will my insurance cover the rest?
- If I am harmed as a result of the research, what treatment will I be entitled to?
- How long will I remain in the study?
- Are there reasons I would be removed from the study? Are there reasons the study might be stopped early?
- Is long-term follow-up care part of the study? What would it involve?
- If the treatment is working for me, can I choose to continue getting it even after the study ends?
- Are there others already taking part in the study whom I could speak to?
- Will I be able to find out about the results of the study?
Involving trusted friends and family members may be a good idea. They can help reassure you that you’re making a decision that’s right for you. In addition, getting a second opinion from a doctor who is not associated with the study can give you a broader sense of whether this particular study is the best one to consider.