In the fourth of our mini-series on cancer clinical trials, we’ll take a look at the questions you should ask the research team before deciding to enroll in a clinical trial. Obviously, the questions to ask will be specific to the trial or trials you are considering, but we hope that this blog post will help you formulate them.
Questions to ask regarding finances
One of the first questions to get out of the way is who will cover the costs associated with the trial. In most trials, the treatment under investigation is provided at no cost to the participant, but there will be other additional costs during the trial such as hospital stays, outpatient appointments, and testing. You will need to find out what is covered by insurance. The additional costs might be covered by the trial, or might need to be paid by your insurance or Medicare.
In the US, a provision in the Affordable Care Act prohibits new health plans from denying coverage for routine care that the plan would otherwise provide, just because a person is enrolled in a clinical trial. The law also prohibits insurers from dropping coverage because a person chooses to participate in a trial. However, the new laws do not apply to grandfathered health plans (insurance coverage enrolled in before March 23, 2010) so if you bought insurance before that date, the Affordable Care Act requirements do not apply to it, but state laws will. If you aren’t in the US and have health insurance, you should check what your coverage includes.
There could well be other expenses too, particularly if the site of the trial is not in your home town, in which case you will need to consider the cost of travel and lodging – especially if it is a long trial and frequent visits will be needed. Some institutions, advocacy groups, and non-profit organizations have funding to help you with housing, or might even offer housing. See the resource list at the bottom of this post for more information.
Questions to ask the research team about the study
Here is a list of questions that you might want to talk through with the research team conducting the study.
- Why is this study being conducted?
- Who is sponsoring/funding this study?
- How much experience does your clinical trial team have with this particular treatment?
- How much experience does your clinical trial team have with clinical trials in general?
- What results are there for earlier phases and how do they apply to me?
- What kinds of treatments and testing will I need to have in this study? How often and where? How does this differ from standard care?
- How is the trial expected to affect my daily life?
- What side effects might I expect?
- How will we know if the treatment is working?
- Do you expect me to have to stay in the hospital for any of this trial? If so, for how long, how often, and who pays for that?
- If I am harmed as result of the research, what treatment am I entitled to?
- How long will I be in the study and how long will the study last?
- If I am in the current standard treatment group and not the new drug group, can I go onto the new drug when I finish the trial if the new drug seems to be better?
- If I am on the new treatment and it is working, can I keep taking it after the trial ends?
- Are there reasons I would be removed from the trial?
- What reasons would lead to the trial stopping early?
- Is there long term follow up as part of this trial, after treatment has finished?
- Can I talk to other people already on the trial?
- Will I be able to find out about the results of the trial? When?
- How will my personal information be protected in this study?
- Are there other clinical trials I should consider that might be better suited to me?
I know it seems like a lot of questions, but these will help you really get an idea of the whole picture of being on a trial. Don’t be afraid to ask all of these questions — the clinical trial team are used to being asked lots of questions because most patients haven’t been on a trial before. Take your time and make sure you feel comfortable with the answers. It also helps to take someone with you to this “question” meeting, so that they can write down the answers or record the session so you can review all the information later.
In our final blog post on Tuesday, we’ll cover the important questions you should be asking yourself, once you are armed with all this information. See you then.