Back in September, we spent some time looking into the overall use of infographics in the clinical research space for a blog post titled, “Using Infographics to Increase Understanding of Clinical Trials.” What we learned is that there is a real opportunity to create more infographics that present information about clinical trials in a way that’s clear, concise and visually-appealing, and that helps answer some of patients’ most frequently asked questions.
So, we decided to take a stab at putting together an infographic of our own. The question we set out to answer: “How often do patients receive placebos in cancer clinical trials?”
When it comes to cancer, only 5 percent of patients diagnosed choose to participate in a clinical trial. Furthermore, a recent Harris Interactive, Inc. poll showed that eight out of ten cancer patients are unaware that clinical trials might be an option for them. Of those who did know about trials but chose not to pursue them, 71 percent said it was due to certain fears they had about participating in a trial. One such fear was the possibility of receiving a placebo in place of treatment during the course of the trial.
So, for our infographic, we decided to dig into the data available on ClinicalTrials.gov to see if we could shed some light on the likelihood of receiving a placebo in a cancer clinical trial. The site listed a total of roughly 2,600 cancer trials in the U.S. About 300 of the 2,600 listed “placebo” as a method of intervention.
What We Found
After a bit of analysis the numbers show that less than 1 percent of all Phase 2 or Phase 3 cancer trials in the U.S. used a placebo alone versus the drug being studied. For the majority of trials that did use a placebo, they used it in conjunction with standard of care treatments, not in place of them. So, while there’s a chance that a patient would receive a placebo in place of the drug being studied, in most of those cases, they would also receive a standard, clinically-tested, cancer-fighting medication in conjunction with it.
Notes on Our Methodology
We used ClinicalTrials.gov to gather and parse all data for our infographic. First, we did a search of all currently recruiting, interventional Phase 2 or 3 cancer trials in the U.S. (Results here.) When we pulled the numbers in August of 2013, there were 2,675 trials returned from the search criteria.
The next search we did used all the same criteria as our initial search, but we narrowed the results by specifying any trial with “placebo” used as an intervention method. (Results here). There were 300 trials that fit the criteria when we pulled the numbers in August of 2013.
Once we had all 300 trials that listed “placebo” as a method in some form or fashion, we searched through each trial manually to determine whether the trial was studying a drug to treat the cancer. If the research was focused on studying something other than treatment of the cancer— a side effect or symptom of cancer or prevention in pre-cancerous patients, for example— we put it into a Not Related category.
At the end of sorting, we had 150 studies in the Not Related category. That left 150 trials that were related to studying treatment of cancer. (Example.)
The 150 studies that were focused on a treatment for cancer were then placed in one of two groups:
- Standard of Care + Study Drug vs. Standard of Care + Placebo
There were a total of 125 trials in this category. Each one focused on a treatment for cancer. One treatment arm consisted of a standard of care treatment plus the study drug. The other consisted of a standard of care treatment plus a placebo. For these trials, even if the patient received the placebo instead of the study drug, they were guaranteed to receive some kind of standard treatment as well. (Example.)
- Study Drug vs. Placebo
There were 25 trials in this category, which is the one most people think of when they hear the word “placebo.” These trials studied a drug to treat cancer. The treatment arms tested the study drug versus a placebo. In these trials, the patient would have an equal chance of receiving either the study drug or a placebo. They would not receive any other standard of care during the trial. (Example.)
How Might This, and Other Visualizations, Help Patients?
Before patients can make truly informed decisions about participating in clinical trials, they need access to clear, concise and accurate information. One way to help might be to present it in a visual format that’s easy to read and digest. If the information we give to patients isn’t clear and accessible, then we are failing to provide them with the resources they need to make critical choices about their healthcare. As we examine new, innovative, and patient-centric ideas for designing trials, we’re also examining ways we can best communicate about trials.
So, please let us know what you think of the Placebo infographic. What could we have done differently? Would you like to see more infographics from us? If so, what question or topic should we tackle with our next infographic? We look forward to hearing your feedback and ideas!