Alliance Sites’ Continual Focus on Placebo Response
The Alliance sites take placebo response within our clinical trials quite seriously – we often lament that it is one constant that keeps our investigators up at night. As such, we engage in a multitude of activities and interventions to manage the placebo effect. For example, one of our research sites, Hassman Research Institute (HRI), has recently embarked on their Placebo-Control Daily Reminder Campaign. In this campaign, all subjects are provided an IRB approved magnet at their Screening Visit which they take home with them and are encouraged to hang in a central location they have access on a daily basis, such as in the kitchen on the refrigerator if they live alone. The magnet coincides with the site’s Placebo-Control Reminder Script (PCRS) which is read to all study subjects at all visits. The PCRS reviews the four factors known in the industry to help reduce the placebo effect, including that the subject’s role is to tell the site the truth about all of their symptoms and reminds them what a placebo is and that the site staff have no expectations of the subject feeling better, worse, or the same.
As an additional illustration of how our sites take placebo response seriously, two of our sites (Collaborative Neuroscience Network and HRI) developed an investigation which is self-funded and IRB-approved. The study explores if the PCRS actually helps reduce the placebo effect among subjects with Major Depression. In this study, subjects are randomized to either the experimental group (the PCRS is read to the subject) or the control group (the PCRS is not read to the subject). All subjects receive a placebo pill BUT are told in the ICF that 50% will get the real MDD drug and 50% will receive the placebo pill (this was done purposefully so as to mirror typical clinical trials). Subjects are debriefed at the end of their participation on the true purpose and methodology of the study. The endpoint purpose is to find out if the PCRS helped manage (minimize) experimental group subjects’ placebo response compared to subjects in the control group. The trial also assesses all subjects’ perceptions of whether they improved (similar to the PCGI), what medication (active or placebo) they believe they received, and side effects (i.e., the study is also exploring the ‘nocebo effect’). The study is currently being ran and a total of 80 completed subjects are needed. Stay tuned for the results!