10 Questions to Ask Before Signing Up for a Clinical TrialElizabeth Nelson
Clinical trials are a brilliant way for certain patients to get new treatments that aren’t available to the public yet, all while helping researchers make advancements that will help other people get the treatment they need. For some patients, particularly terminal patients or those for whom the traditional treatments are not effective, these unproven drugs could save or extend their lives.
However, clinical trials aren’t for everyone. Most trials are only looking for a very specific subset of the population, and there can be significant risks to participants, depending on the type of drug. There are lots of questions you’ll probably want to ask when you’re considering taking part in a clinical trial, and you probably haven’t even thought about some of them yet.
Here are some questions you should ask before you sign up for a clinical trial.
10. What are the risks?
Every clinical trial has risks, but they differ based on what type of treatment is being administered and to whom. Be sure to ask for a list of potential side effects and other types of risks so you can weigh them properly before deciding to take part in the trial.
9. How am I being protected?
As a clinical trial participant, you have a right to be fully informed before giving your consent to be a participant in the trial. All clinical trials are required to undergo review by scientific review boards prior to getting started, and an institutional review board (and possibly a data and safety monitoring board) will continue to ensure that the researchers are following protocol throughout the process. But feel free to ask for the specifics regarding these and other safety and privacy features of your clinical trial.
8. How do the risks and benefits stack up?
Knowing the risks of your clinical trial may not be enough. You might also want to know what the potential benefits are and how those risks and benefits compare to other treatments available to you.
7. What is known about the safety of this treatment?
While researchers won’t be able to tell you everything about the safety of the treatment they’re testing—simply because they don’t know yet—they should be able to give you some information about how safe they expect the treatment to be, based on their observations from prior testing and trials. Many new drugs also have similarities to existing drugs, so the researchers may have some educated guesses about what the treatment will be like based on similar treatments.
6. What are the chances I’ll get the experimental treatment?
Most clinical trials involve some sort of control group, which means some of their participants will receive a fake drug rather than the real treatment. In some cases, however, even the control group is receiving cancer treatment—it may just be something that’s already tried-and-true rather than the new treatment being tested.
5. What does the treatment involve?
Before deciding to do a clinical trial, you should know what type of treatment (oral, injection, etc.) you’ll be given, how often, and for how long. Be sure to ask what types of tests you’ll have to undergo to determine the effectiveness of the treatment and when each of these will be conducted. Find out how where you’ll have to go to receive your treatment and tests and whether transportation will be provided if you need it.
4. What other expectations are there?
Some clinical trials involve a strict set of rules regarding participants’ lifestyle during the trial. Some participants may have to eat (or not eat) certain foods, get a certain amount of physical activity, track their habits on a daily basis, or do other activities on their own time to help the researchers get more accurate results.
3. Will you tell me the results?
At the end of your treatment, you’re probably going to want to know how well it worked. Ask whether you’ll be given your individual results (and when), as well as when you can expect to hear about the results of the whole trial.
2. What does it cost?
In some cases, insurance will cover a patient’s cost of care during a clinical trial, but that is not always the case. You’ll want to ask whether the treatment is covered by your insurance and what your out-of-pocket cost will be.
1. How will I stay in contact with you?
Find out who you can call if there are any complications in your treatment or if you have more questions. Ask what the researchers will do in terms of following up with you after the study and whether they will be in touch with your doctor as well.
Should we add any important questions to our list? Let us know in the comments.