MYTH 1: My doctor wouldn’t have told me about the clinical trial if he/she didn’t think it was in my best interest
TRUTH: While the consent form will likely include a phrase like “there may be no benefit to you to participate” the assumption that the physician is acting in the best interest of the patient is a strong notion to overcome. Although there are rare cases where early trial data indicates direct benefits are occurring, it is more often than not that a clinical trial holds the prospect of no direct benefit to the participant. If we knew which treatment option was best, there would be no reason to conduct a comparative clinical trial.
DISPELLING THE MYTH: Some ways to assist participants in understanding this is to have a non-treating clinician conduct the informed consent process and reminding the patient that the protocol defines their care plan unless they decide to stop participating in the trial or have an adverse reaction that requires them to stop participating. Sometimes having an individual who is not involved in their care talk about a clinical trial creates enough space for the patient to recognize this is not a treatment decision being made by their doctor.
MYTH 2: I don’t need to remember the name of the drug or device I am receiving on this trial because all the information is in my medical record. If another doctor needs to know, they can find it by looking at my medical record.
TRUTH: Ideally all the details of the investigational drug or device would be well documented in the patient’s medical record and accessible to all treating clinicians. In reality, this is not always the case. Paper charts are becoming a thing of the past and as hospitals convert to electronic medical records, the goal is for patient information to be accessible to those who need it for patient care continuity. The reality is not all hospitals are there yet.
DISPELLING THE MYTH: Let patients know that they should either learn the name of the drug or device they have received as part of the clinical trial (along with dose, route of administration, and length of time they are on it) or carry with them a card that contains all of this information. This will ensure all of the doctors they see have the information in the event that they are not at their usual medical facility or the medical record does not contain this information.
MYTH 3: If I don’t participate or I choose to stop participating in the clinical trial, I won’t get as good of care
TRUTH: This is a commonly held belief and one that I wouldn’t normally qualify as a ‘myth’ but perhaps rather a ‘valid perception’ informed by the patient’s past experiences with the medical community. Believing that your care will be equal whether you participate in the trial or not is a bit of a trust exercise by the patient. While recruitment is important to the physician-researcher, the way that they care for and treat their patients should be equal whether or not their patient is participating on a clinical trial.
DISPELLING THE MYTH: Many consent forms will include language explaining that a patient can stop participating at any time for any reasons. This is important language to include in every consent form. In addition, suggest that the physician speak directly with the patient about how their experience on the trial may be different from the usual care they would receive if they were not on the trial. This should include highlighting any additional visits or testing that will occur. The physician should also reiterate to the patient that they are free to stop participating at any time. Hearing this message from the physician will provide some assurance to the patient that they will not be punished for withdrawing or refusing to participate.
What other myths do you see patients believing? What is the obligation of research team members, monitors and sponsors in ensuring patients are appropriately educated about what it means to be a research participant?
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