What is a clinical trial?
Clinical trials are research studies to determine if new drugs, treatments, and medical devices are safe and effective for people.
Why do we conduct clinical trials?
Clinical trials show us what works and what doesn’t in medicine and health care. They are an essential step in the process of developing new and better methods of diagnosis, treatment (aka standard of care), and prevention of disease. Clinical trials answer important questions, including:
- Is this new treatment better than what’s currently available? (e.g. Is it more effective, Does it have fewer side effects? Is it more convenient?)
- Does it work for all patients or does it help some more than others?
- Is it safe for people?
Without clinical trials, we would not be able to determine if new drugs, treatments, or devices are safe and effective for people.
Who can participate in a clinical trial?
Adults of any age and children can participate in clinical trials. To ensure the study is valid, each clinical trial has specific criteria for who qualifies to participate. These criteria include age, gender, the type and stage of disease, previous treatment history, and overall medical condition. Your doctor will help you determine if you are a candidate for participation in a clinical trial.
How should I decide whether to participate in a clinical trial?
Ultimately, the decision to participate is completely yours. First, it’s important to talk with your doctor. Ask questions. Be honest with your doctor - and yourself - about your hopes and concerns. There is always uncertainty in a clinical trial. We can’t know what the outcome will be before we decide. That’s why the trial is being conducted - to learn more.
How does my participation help others?
Successful clinical trials depend on people’s participation. Every participant provides more data. More data results in more knowledge, and more knowledge leads to a better standard of care and better patient outcomes. But, lack of participation is the biggest obstacle to clinical trials. Often, patients aren’t even aware they’re an option. Successful clinical trials are essential for better patient outcomes - and participants are essential for successful clinical trials.
What if I change my mind about participating in a clinical trial?
All clinical trials are voluntary. You have the right to leave the study at any time. If you think you want to leave, it’s best to discuss your decision with your doctor first. It’s important to understand what other options exist and if there might be any effects on your immediate or long term health.
How are the risks of clinical trials addressed?
All trials conducted in the US are reviewed and approved by an Institutional Review Board (IRB) made up of physicians, scientists, researchers, and community experts. The US government has established federal standards which all clinical trials must meet. In addition, clinical trial researchers follow a process that ensures “informed consent” from all participants. Informed consent means participants are given all the information needed to understand the potential risks, benefits, and alternatives for the study. This ensures participants make a fully informed decision on whether or not participation is the best choice for them.
What’s a protocol and why is it important for participants?
For each clinical trial, the researchers (also called investigators) must prepare a specific plan for what the trial seeks to accomplish and how it will be conducted. This plan is called a protocol - it defines the reason for conducting the study, who is eligible to participate, the number of participants required, the information gathered from participants, the schedule of tests, and medications for participants, and the duration of the trial. The protocol helps you understand what’s required and what to expect over the course of the trial should you choose to participate.
What are the costs? Will I have to pay for this?
It’s essential to discuss any financial considerations with your doctor, as part of your decision on participation. In clinical trials, the costs of tests, medications, visits, etc. are often paid by the sponsor of the clinical trials and participants are not responsible. The protocol and discussions with your doctor will provide you with specific information on any cost requirements.
Will I receive compensation?
Some, but not all, clinical trials provide compensation to participants. Your doctor can provide information on what, if any, compensation is available.