It's not easy to be a clinical trial participant. You have to give up much of your time and might not even get paid. The good news is that by doing your research before enrolling in a trial, you'll know what you're getting into—and hopefully have an easier time staying informed about the process. Here are some tips on how to stay informed as a clinical trial participant:
Understand what are the clinical trials
Clinical trials are research studies that look at new treatments. They can also be used to test existing treatments in different situations.
A clinical trial might involve one or more sites, and each site is called a center. A center is usually operated by an academic medical center or teaching hospital, but it could also be part of a commercial research organization.
Clinical trials are designed to answer specific questions about how well drugs, devices, diagnostics, and preventive measures work for people with certain diseases or health conditions. Clinical trials help doctors learn more about safety and effectiveness, so patients receive the most effective care possible.
When you volunteer for a clinical trial as a patient:
- The medical care team will work with you to make sure that its benefits balance any risks of being in the study.
- You may get better access to care than if you were not in a clinical trial.
- You can help researchers learn more about experimental treatment or test an existing one.
Find out who is eligible for a clinical trial.
Once you have learned more about clinical trials, it's time to look at specific trials that could be right for you. The first thing to do is ensure the trial is open to people with your condition or disease. You'll want to look for trials that say "open" or "recruiting," as well as any other information about who can participate in the study. Some studies may limit enrollment based on age or gender, race/ethnicity, or other factors such as medical history or lifestyle choices (such as smoking).
It's important to note that some trials may only be available at specific locations; if this is true of one of your top contenders, consider researching whether others are nearby so that treatment isn't too far away from home!
Before you commit to participating in a clinical trial, do your research
Before you commit to participating in a clinical trial, do your research. You want to feel confident that the trial is legitimate and will benefit you. Here are some steps you can take:
- Check the trial website for information about the trial. Look for details on how long it lasts, who's running it and why they're running it, what risks and benefits may come along with participation, and whether there's any compensation or travel reimbursement available for participating.
- Ask about the risks, benefits, and side effects of the drug being tested (and any other drugs or procedures involved), as well as who will be conducting your testing and how qualified they are.
- If you have any questions or concerns, talk to your doctor.
- Ask if there are other clinical trials you can participate in that may be more likely to benefit you. If there aren't, consider whether this trial is worth the time and effort. You'll have to go through blood tests, physical exams, and possibly other procedures before and during the trial, so make sure it's worth your while.
- Finally, if you decide to participate in the clinical trial, make sure you understand all of your responsibilities. For example, if you have to travel for the trial, does the company reimburse or cover any costs? If not, how much time off from work will be required, and what happens to your benefits during that time?
Ask for complete information before you enroll in a clinical trial.
Before you enroll in a clinical trial, make sure you are completely informed. You should be given all the information listed below:
- What are the risks? This can include anything from being hospitalized or having an allergic reaction to a death.
- What are the benefits? This includes any personal benefit or improvement from participating in this study (e.g., if they need to give blood samples or take pills).
- Why is this study being done? This question aims to ensure that you understand why your participation would help others who might have similar medical issues to yours one day down the road, especially if it involves giving up some time and discomfort for someone else's benefit! If there isn't any clear purpose for your enrollment, consider whether there might be another opportunity out there with better potential outcomes for everyone involved--or just say no thank you!
- Are you sure this is safe? This question may seem obvious, but it's important to know that your safety will be taken into account during the entire process. If there isn't any clear explanation about how you'll be protected from harm while participating in this particular study.
- Do you have any questions for me? This question is meant to give you the opportunity to ask any additional questions that may have come up while reading through this list of questions. You should feel free to ask anything that comes up in your mind at this point--after all, it's your body and your health on the line!
Ask about the possible long-term effects of the medication.
You should also ask about the possible long-term effects of the medication. For example, some medications can cause liver damage, while others can be addictive. Even if your doctor doesn't think these are issues for you personally, it's still important to know what might happen down the road to make an informed decision about whether or not to continue taking the drug after its trial period ends.
You should also ask about the possibility of withdrawal symptoms if you suddenly stop taking the medication or if it does not work for you. If no one has thought about this before, your doctor may need some time to find out what kind of side effects they could be dealing with as they progress with their trials to test multiple dosages and types of drugs on different populations (i.e., younger vs. older patients).
Know your rights as a clinical trial participant.
As a participant in a clinical trial, you have rights that must be honored by the researchers and their staff. These rights include:
- The right to withdraw from the trial at any time. You can stop taking the medication or stop participating in other aspects of the study without penalty. If there are adverse effects related to your participation in the trial, you should talk with your doctor about whether or not it is appropriate for you to continue taking part.
- The right to receive information about the trial and its results. This may include results from previous patients who participated as well as information about possible risks and benefits associated with taking part in this particular study (and/or others like it). This will help ensure that all participants are making informed decisions about their participation before agreeing on anything.
- The right to confidentiality. All information about you that is collected as part of the clinical trial will be kept private and confidential. This includes any data related to your health or the results of any tests performed during the study.
- The right to compensation. If you are injured or have an adverse reaction as a result of taking part in this trial, you may be eligible for financial compensation. This is especially important if it was not clearly explained to you that there were risks associated with participating in the study in the first place.
Consider reimbursement rates for the time and effort you'll be spending on the trial.
The time, effort, and personal sacrifice that it takes to participate in a clinical trial are significant. Though you may be doing it for the good of science or the advancement of your health care, you should know how much you will be reimbursed for your participation before enrolling. If a research team does not disclose their reimbursement rates before you sign up for a study, ask them about them during an interview.
If researchers have already told you what they plan to pay participants, but it doesn't seem right to him/her (e.g., the hourly rate per hour worked is much lower than what he/she would make at his/her regular job), tell them this! The best thing someone can do as an informed participant is speaking up when they think something isn't right—even if they're afraid they'll hurt their chances of getting into another trial later on down the road!
Speak up about your concerns with the study.
Finally, it's important to speak up if you have concerns. While clinical trials are designed to offer the best possible care, they can be very different from regular treatment, and every patient reacts differently. If a study doesn't seem right for you or your family member, don't hesitate to express your concerns to the researcher and ask questions about any issues that arise during the trial. In addition:
- Understand how much time and effort each participant in a study requires. It may be more than you were expecting!
- Make sure there are no restrictions on where or when you can go out of town while participating in a clinical trial (or schedule around these situations if necessary).
- Get details about financial compensation before signing up for any clinical trial research studies; some studies offer limited reimbursement for travel expenses but nothing else beyond this minimal payment.
Ultimately, it's up to you to ensure that your rights, interests, and concerns are represented during the clinical trial process. If you have any questions or concerns about a particular study, don't hesitate to talk with your doctor about them. Remember that you're in charge of your own healthcare decisions—and no one else can do this for you! Try AllStudies.com to find and enroll in clinical research studies near you.