Placebos in Cancer Clinical Research: An Infographic 6

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?”

lilly, placebo, clinical trials, cancer, infographic, medical research

Background

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:

  1. 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.)
  2. 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!

6 comments

  1. “for 99% of cancer trials if a placebo is used, it is given together with standard treatment” is misleading, implying that “99% of those cancer trials that use a placebo give it together with standard treatment.” Move the comma to clarify: “for 99% of cancer trials, if a placebo is used it is given with standard treatment.” Thanks.

  2. I think if somehow you could include a follow up showing survival rates for each of the studies. People have a fear of the unknown and if there was some kind of “here’s how everything turned out” info graphic, it’s another piece of information that people can use to decide if they want to participate in a clinical trials.

    Or give information graphics in general saying “people in a standard of care+study drug” typically fair this well, or not! I don’t know if it’s possible to find/give out that info, but it would be one more piece of the puzzle for people looking to join clinical trials.

  3. Reblogged this on Living On The Edge and commented:
    While Placebos have been in use in Clinical Trials for a long time, I always wondered about the fate of patients who would receive a Placebo rather than the actual drug. This Inforgraphic by Lilly COI team provided an insight into Cancer Clinical Research and the use of Placebos. Thought I’d share it. Personally, I feel we ought to leverage newer technology like Human Genomes and perform more targeted research to not only reduce the cost of clinical research but more importantly reduce the impact of a critically ill patient receiving a Placebo instead of teh actual treatment.

  4. Pingback: Patient Participation in Clinical Trials Infographic « lillycoi

  5. Pingback: Why Aren't More Patients Participating In Clinical Trials? [INFOGRAPHIC]

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