Clinical trials are at heart to all medical advances. However, they are conducted with the assistance of human volunteers. They aim to determine if a new drug, surgical procedure, medical device, or a new way of using an existing treatment is safe and effective.
Clinical trials follow strict ethical and legal codes and regulations to protect the safety and rights of volunteers. These rules are set and enforced by individuals and groups at the sites where the clinical trials take place. Such groups include an Institutional Review Board and government agencies such as the Food and Drug Administration and the Office of Human Research Protections.
All clinical trials have guidelines about who can participate. These guidelines are called inclusion and exclusion criteria. However, both criteria are based on age, gender, type, stage of disease, previous treatment history, and other medical conditions.
Before joining a clinical trial, a participant must qualify for the study. Moreover, some studies look for participants with illnesses or conditions studied in the clinical trial, while others need healthy volunteers.
Finally, some studies need both types of volunteers. Inclusion and exclusion criteria are not used to reject people personally; instead, the requirements are used to see if the study is a good fit for participants, keep them safe, and help ensure scientists can find the information they need.
In some studies, volunteers who are in good health are needed to test a new drug or device that has never been given to people or only a few people. However, in clinical trials, they are called “healthy volunteers.” Although it can be hard to know what “healthy” means, a healthy volunteer is typically a person who is free from the disease or condition being studied or who has no major health problems.
However, while participating in a clinical trial, a healthy volunteer is given a drug not to test if it will treat disease but rather build new knowledge about the drug and see if people can safely use it. Results from healthy volunteers are compared to results from patient volunteers who do have the disease or condition.
Here are some questions to ask your doctor to help you decide if you want to take part in a clinical trial:
The Study
What is the purpose of the study?
Who will fund the study?
How are the results and the safety of participants monitored?
How long will the study last?
What will I be asked to do if I participate?
Possible Risks & Benefits
What are my possible short-term benefits?
What are my potential long-term benefits?
What are my short-term risks, such as side effects?
What are my possible long-term risks?
What other options do people with my disease have?
How do the potential risks and benefits of this trial compare with those options?
Participation & Care
What kinds of therapies, procedures, and tests will I have during the trial?
Does it hurt, and if so, how long?
How often does the study require me to go to the doctor or clinic?
Will I be hospitalized? If so, how often and for how long?
How do the tests in the study compare to those I would have outside of the trial?
Will I be able to take my regular medications while in the clinical trial?
Where will I have my medical care?
Who will be in charge of my care?
What follow-up will there be?
What will happen at the end of the study?
Will I be able to see my doctor?
Personal Issues
How could being in this study affect my daily life?
Can I talk to other people in the study?
Cost Issues
Will I have to pay for any part of the trial?
If so, what will the charges likely be?
What is my health insurance likely to cover?
Who can help answer any questions from my insurance company or health plan?
Is there any reimbursement for travel costs or child care?
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Tips for Asking Your Doctor About Trials
Take a family member or friend along for support and to help ask questions or record answers.
Plan your questions, so you don’t leave any out. Don’t hesitate to ask any new questions you think of while you’re there.
Would you mind writing down the answers so that you can review them whenever you want?
Ask about bringing a tape recorder to make a taped record of what’s said (even if you write down answers).