Our Continued Consciousness of Placebo Response
One of the key aspects that link all of the Alliance sites is their unwavering commitment to be perpetually and systemically conscious of how the placebo effect intrudes on their hard work enrolling quality subjects into trials as well as rating subjects on their severity indication throughout subject study participation. From site Principal Investigators, Sub-Investigators, Psychometric Raters, Coordinators, and lab staff, to Front Office staff who first greet patients and subjects, our sites are diligent about ensuring all of these individuals are keenly aware of their role to best reduce the placebo effect in our assigned studies.
We are just as proud that the Alliance sites take a leadership role within our industry to implement strategies aimed to minimize the placebo effect and, moreover, empirically explore the effectiveness of such methods and subsequently share these results with our sponsor, CRO, and site colleagues. For example, in 2018 we developed an IRB-approved protocol to research the placebo effect reducing potential of our Placebo-Control Reminder Script (PCRS), which methodically reviews with subjects the commonly-cited crucial causes of placebo response. After approximately 10 months of enrolling subjects with major depression at two of our sites, we obtained the needed number of subjects to power the investigation and found that, compared to subjects in the Control Group who were not read the PCRS, subjects in the Intervention Group who were read the PCRS stayed significantly more depressed (p<.02) at the endpoint visit – i.e., the PCRS substantially helped manage the placebo response among subjects who were in a current major depressive episode. These results were presented at the annual CNS Summit Conference in Boca Raton, FL in November 2018, and more recently, we were accepted for ISCTM’s February 2019 Conference to present a poster regarding these results and to specifically discuss how the PCRS can be efficiently incorporated into trial methodology.
Since this work, we are very proud to see that sponsors and CROs alike have appreciated our findings and have licensed the PCRS in their trials, which we gladly support through our additional services of tailoring the PCRS to a specific protocol design and developing PowerPoint slides training site raters (such as at IMs) on how to effectively implement the PCRS as well as thoroughly reviewing other empirically grounded methods for minimizing the placebo effect. Additionally, we are very pleased that our research on the PCRS continues to expand in 2019 as we commence Phase B of the PCRS protocol to enroll subjects with Schizophrenia and Schizoaffective disorders – we expect results to be out in late 2019. In this phase, we explore what we think is an improved PCRS (Version 4) where, for instance, we instituted a meta-comprehension evaluation by having the rater ask the subject at the end of reading the PCRS to explain in his/her own words their understanding of the meaning of the script and its purpose. Stay tuned for these results!
Finally, as always, all of our Alliance sites would be greatly appreciative talking with each of you about all the work we engage in to best reduce the placebo response within our trials. These meetings do not have to wait until a conference is held. You can email any of our Alliance leaders (e.g., Bobbie Theodore at firstname.lastname@example.org) at any time throughout the year to schedule these meetings with our sites.