Participants are the most important stakeholders in a clinical trial setting, and they pass through multiple doctors, referrals, and suggestions by loved ones before getting enrolled into a trial for an ailment. I assume in a patient’s perspective, clinical trials provide access to free or new treatment, a close attention to their condition by the doctors, and hope for a solution. In the past few years, I have been enrolling patients for number of trials that we have been conducting and I noticed at the time of recruitment, our recommendation was one of the primary factors influencing patients’ decisions to enroll into the study. This may also imply a therapeutic misconception of research participants in that believe they are being provided the best treatment, primarily because of reassurance from us, and that the experimental drug is not risky and a better form of treatment. This reiterates the ethical and moral duty for us to inform the participant of the difference between available treatment and trial participation.
On the other side of the coin, patient’s noncompliance has the potential to tarnish a clinical trial. In a clinical trial setting, we often forget but many patients walk away with nothing. They may experience adverse events, they may have just participated in the placebo arm, or hampered with several visits to trial clinics. At the end of the trial, they are less likely to hear about the study outcome and whether they made a difference.
In recent years, patient engagement in clinical trial design is a topic of interest. The advantage of including patients in clinical trial protocol designing may urge the simplification of protocols and reduce the study visits and costs associated with it. This might even improve the compliance of the participants in the trial. In my experience, the best way is to assure patient compliance is optimal communication with them. Listening to them, discussing the patient information sheet in detail, allowing them to discuss any concerns, discussing any lab results we obtained during their participation and thanking them for their participation makes a huge difference.
Sivabaskari is a post-doctoral research fellow from the University of Adelaide, Adelaide, Australia. Her research is primarily focused on understanding and characterising myocardial infarct patients without the evidence of coronary artery disease also known as MINOCA. @TharshyP