With so many clinical trials for Dravet syndrome actively enrolling, it is an important time to consider the impacts that talking about experiences in an ongoing trial can have on the outcomes. If you are participating in a clinical trial and observing particularly profound changes following treatment, it can be quite tempting to share that information. Maybe you are excited about improvements, or concerned about potential adverse effects, and want to share with others or find out if anyone else in the trial is seeing similar things. Social media has connected us all in ways that would not have been possible 20 years ago, but that connection also means information travels faster and more broadly than ever before. When you share your experiences on social media, instead of telling a few friends, you are now including hundreds or thousands of people in your reach. Some trials have begun to request that participants sign a document indicating they will keep their experience confidential, but this is not always the case. Ultimately, the decision about how much or how little participants disclose is up to them. So, WHY should you choose not to share your experiences publicly?

A major challenge with all research is overcoming bias. An experimental bias is when an individual involved in a research study allows their personal impressions or beliefs to affect the outcomes. While that might sound nefarious, the reality is that the impact of biases is generally unintentional; however, that also means biases can creep into studies quite easily. Bias can influence all aspects of research from developing a hypothesis, designing experiments, assessing experimental data, and drawing conclusions. For the most part, avoiding biases in these areas is the responsibility of researchers. However, when human patients are involved in studies, it introduces an additional source of bias. We have all heard about the “placebo effect,” where an inert or “dummy” pill may be perceived to have an effect on a participant’s outcomes. Without actively realizing it, the human brain begins to find patterns that support our pre-existing beliefs or hopes. In the case of the placebo effect, the trial participant is hoping for the experimental therapy to work and this hope can impact the patterns they see after taking the placebo. Bias can also be impacted by the perceptions of those around us. In a clinical trial, if a patient hears another participant has seen improvements (or worsening symptoms) in a particular area, they may suddenly be more aware and focused on that specific outcome in their own case. Researchers try to avoid these types of biases affecting outcomes is to focus on as many objective measures as possible. Objective measures, like results from a blood draw analysis, are less likely to be affected by these types of biases. However, in a disorder like Dravet syndrome, many of the measured outcomes in clinical trials rely heavily on patient/caregiver reporting and clinician assessments, both of which could be impacted by bias because they are more subjective. These more subjective measures can make interpretations around the efficacy of a therapy less clear cut, and thus, might impact whether a new therapy is approved. As a trial participant, you can support the efforts to reduce bias by being very careful about how much you share details of your personal experience while the trial is ongoing.

Some additional issues that can arise from broadly sharing details from an ongoing clinical trial include “unblinding” the study. A clinical trial often includes a random assignment of experimental drug and placebo pill to groups of patients participating in the trial so that the two groups can be compared. These trials are generally “blinded,” meaning the majority of the researchers as well as the participants are unaware of who receives the therapy versus the placebo. This is an effort to circumvent the “placebo effect” discussed above, and determine what is the effect of the experimental therapy when the placebo effect is considered. However, when trial participants openly discuss their experiences, it can start to become apparent who received the placebo and who received the experimental drug, essentially “unblinding” all of the participants and introducing bias into their interpretations of efficacy. Lastly, sharing sensitive information to another trial participant might cause undue stress to them. There is an example of a patient with Duchenne muscular dystrophy whose parents found out the trial had failed from Facebook. This caused a significant amount of distress because the trial coordinator did not even have all the information yet, and so the family did not have a source to ask important questions.

Broad sharing of clinical trial details could have significant consequences. If you signed an agreement not to share any sensitive information and then do decide to share on social media, it could result in withdrawal from the trial. Additionally, if biases or unblinding compromise the integrity of a clinical trial, the trial could be in danger of early termination or failure of a therapy that might have been an effective option for others in the community. Ultimately, the choice of how much to share is a personal decision for participants and their families. At the end of the day, we are all hoping for the same thing- improved therapies that lead to a better quality of life for those living with Dravet syndrome. To that end, we should all do our best to help clinical trials be as accurate as possible so that researchers reach the correct conclusions about whether a therapy is helpful and effective, or not.