Placebo composition as tabula rasa in clinical trials

Abstract

The concept of the placebo as a tabula rasa, on which the API’s signature is scribed, appears to be an increasingly untenable proposition. Ironically, it may have been made so, in part, because of the increased complexity of emerging excipients used to deliver APIs’ to specific pharmacological targets. Many of these excipients possess intrinsic pharmacological activity through well defined mechanisms. Consequently, placebo controlled clinical trials must factor in the excipient bioactivity as well as disclose placebo composition, so that pharmacological responses that are innate only to the API, may be better discriminated.