What is a placebo, Eligibility criteria, and How to find a clinical trial
CISCRP is dedicated to providing educational resources and empowering people through all steps of clinical research participation. This includes everything from general awareness to what to expect during a trial. Or, as with one of our newer brochures, how to actually find a trial. We recently published three resources to help people understand certain parts about trials.
Especially during Health Literacy Month in October (but also all the time), we can’t emphasize enough the importance of providing health-related education and tools to patients and the public. We’re constantly reviewing our materials and getting feedback from the public so we can fix any gaps in our resources. The ultimate goal is to provide guidance to help with decision making. To do this, we provide details, such as potential risks and benefits, clear action items, and a summary of possible options. And we strive to do this without actively encouraging participation and encouraging the reader to make the best decision for themselves and their loved ones.
Each resource CISCRP creates, such as brochures, goes through a thorough review process to ensure the readers’ needs and the above goals are met. This includes writing, several editing steps, getting feedback from a Review Panel and surveys, getting internal feedback, and approval from an IRB.
What is a Placebo?
If you asked a member of the public to pick the first word that comes to mind when they think “clinical research,” there’s a good chance they would say placebo. And then if you asked them to define it, they may say something like, “It’s just a sugar pill.” Since there’s a lack of awareness about clinical trials and how they work outside of CISCRP, that’s a fair guess. But it’s much more complicated than that. To help clear up the confusion for patients and the public, we updated our What is a Placebo? brochure.
The idea of a placebo has many parts. There’s why it’s used, how it’s used, and the “placebo effect,” for starters. There’s also the concern of not knowing whether or not a participant might receive a placebo. The brochure explains why it’s important that participants don’t know whether or not they receive a placebo, and why they can’t choose their treatment. It also explains how to know whether or not a placebo is even a possibility.
Then there’s the issue of randomization and blinding. How do researchers determine who receives a placebo? How does anyone know who gets what? Because many readers prefer visual mediums, we created a graphic structured a bit like a flow chart that shows treatment being randomized and that the participants and trial doctors usually don’t know who’s receiving what.
Eligibility Criteria for Clinical Trials
Our team—specifically, our events team that directly engages with different communities—heard from many different people at events that patients who want to join a trial are confused if they are told that they cannot join. Some people feel offended or upset, thinking that they were denied because of personal reasons. However, they may not be aware of eligibility criteria. So, we created an Eligibility Criteria for Clinical Trials infographic explaining the basics.
The immediate question many readers might have is why does it even matter? As mentioned in our graphic, eligibility criteria are necessary to protect participants’ safety and to get the most accurate results possible. Hopefully this explanation helps readers understand why researchers can allow only certain participants to join.
It’s vague to simply say “there are specific reasons why you can or can’t join,” so we provided some examples of both inclusion and exclusion criteria. This ranges from the most obvious, such as having the condition a treatment is designed to help, to other factors someone may not even think about, like needing to be a certain weight to join, or not being able to join because of having previous treatments that would affect how the trial treatment would work.
The infographic also provides patients who do not qualify or who did not want to participate with other ways to get involved and contribute to research. For example, participating in an observational study, joining an advisory board, or even simply discussing with friends and family.
And, of course, there may be other trials they can join.
How to Find a Clinical Trial
We have lots of information about clinical research participation, including helping to decide if participation is right for you (see our brochure, Should I Participate?). But to even get to that stage, a person needs to know How to Find a Clinical Trial. Some patients may think that their doctors will tell them about any trials they might be able to join, but that is not always true.
The process is not as simple as just finding a trial, though. As we explain in the brochure, there are multiple steps beyond simply finding a trial and joining. Before someone even starts looking, a patient should understand their condition to help identify which trials might be best for them.
As with anything in today’s world, looking online is a great place to start looking for a trial, so we provided three main clinical trial search sites based on location. We recommend putting together a list of trials that interest a potential participant. Then we suggest putting together a list of questions for trial staff, and then contacting them.
This is only the first step of deciding whether to join or not.
Conclusion
Clinical research participation is a complicated process, from thinking about joining, to figuring out if you should join, and then actual participation. We’ve created the three resources listed above to help people in all steps of the process, but we have a lot more in our Resource center that support patients, caregivers, and others across all parts of research.
One of CISCRP’s missions is to partner with patients and the public. This includes working together with patients, community members, and healthcare professionals to create our brochures, infographics, and other materials. We are always open to feedback on our materials or any other resources we should make. Feel free to contact us!
Written by: Scott Finger
