Q. Why are clinical trials important?
A. We all expect (or at least hope) that researchers will find new and better treatments and vaccines to prevent and cure the serious diseases of mankind. These treatments and vaccines are tested in volunteers through clinical trials to ensure that they are safe and effective.
Q. How can I be sure it’s safe to participate in a clinical trial?
A. Some people are concerned that the study may be unsafe or dangerous or that they won’t be allowed to leave the study if they don’t like it. In some African-American and Latino communities, people may know of studies, such as the Tuskegee Syphilis Study, that were conducted before the government established strong ethical guidelines for the conduct of clinical trials.
The Tuskegee Syphilis Study was an unfortunate episode in American science. Many important safeguards and changes have been made since then. The Federal Government now has strict rules and regulations that all government and drug company researchers must follow to protect participants in clinical trials. These rules require that participants are clearly informed of the risks involved in the trial and they must agree, in writing, to be included in the trial.
The rules require that, before a study can begin, it must be approved by a group of experts called an Institutional Review Board in the medical school, agency or hospital conducting the trial. In addition, all studies must monitor the data collected and the safety of the trial participants. In some trials, this is done through a group called the Data and Safety Monitoring Board. This process ensures that the risks of trial participants are reduced as much as possible and that the information collected is accurate and useable. In rare cases, a trial may be stopped early, either because the participants are being exposed to too much risk, or because the trial has already answered the questions it was designed to explore.
Q. What are some steps to help me with my decision to participate?
A. Clinical trials are very important tools to develop new treatments and vaccines. To decide if clinical trial participation is right for you, you should take these important steps:
1. Get the facts about the clinical trial: What is being studied? How often will you visit the clinic? What lab tests are needed? What costs, if any, will you have to pay? Will you be paid for your time and travel expenses? What are the possible risks? Do not agree to be in a clinical study if you know that you honestly don’t plan to stick with it.
2. Know your rights and your responsibilities: You have the right to decline to participate in a clinical study. You have the right to quit after you have begun. You have a right to keep your existing medical care.
3. Talk with others who have participated or are participating in a clinical trial: Learn more about their experiences.
Deciding to participate in a clinical trial is an important personal decision that you should make based on facts, not on myths or hype. When it comes to clinical trials to develop new and better treatments and vaccines, it’s a new day.
To access Ohio State research studies, our research studies page has a list of tools and resources.