Explaining Control Group assignments to Patients
When someone enters into a clinical study, it is often with the hope that they might receive a new treatment for conditions that are negatively impacting their quality of life, and in some cases are terminal. Understandably, being informed that their clinical study has assigned them to the control group, which will receive the standard treatment course, can be a substantial disappointment. However, there are strategies you can employ as a clinical research site to make delivering the news less disappointing and to ensure your patients know the value of their contribution. It is essential to address patients’ most common questions and concerns with compassion and empathy.
Why do we even need to use control groups?
When patients express confusion or concern about the need for control groups in the first place, it’s important to emphasize their benefit to the overall quality of research into their condition.
You could say: Control groups serve as a standard, or baseline, for the performance of a new treatment. They allow us to rule out external factors that may be skewing our results. By being in a control group, you are helping our research to be more fair, accurate, and safe for future patients.
Can’t you put me into the experimental group?
Patients, particularly those who don’t fully understand the study’s clinical protocol, may insist that you as a member of the research site should be able to “help them out” and move them into the experimental group. However, it’s important to help them understand that most new drug trials utilize randomized trials with single or double-blind procedures, and this is not possible.
You could say: Unfortunately, in order to be fair and have our results be generalizable to more people with your condition, we have to assign patients’ to their respective groups randomly. My team can’t influence the selection process, and you had an equal chance of being assigned to this group or the experimental group.
I’m not really part of the study if I’m in the control group.
Some patients feel that they are not contributing to “real research” if they are not receiving the experimental treatment. To combat this misconception, it’s necessary to remind them of the essential nature of control groups and validate their experiences in the research.
You could say: While this may initially feel disappointing, control groups are a necessary part of clinical trials. Your participation will play a crucial role in proving or disproving that the treatment is impactful in improving some health conditions. You are absolutely critical to this study.
Learn more strategies for Clinical Research Sites:
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