You are almost there, at the clinical study which you have planned for, found financing for, aimed and worked so hard for. The active is formulated, perfectly. You have your pill, cream, ointment, spray or what have you. And compared to this great product-to-be you have your placebo. You are ready Or are you? Do you have your placebo?
Think about it. The placebo should look the same, feel the same, taste and smell the same, behave the same when sprayed, touched, put on the tongue or on your skin. But it should not be made with the same ingredients. … Yes, this can be complicated. Very complicated.
We just finished a project for a client that needed a placebo in time for their clinical study, an already scheduled study. The timelines were incredibly tight but the most challenging part was that the product and placebo needed to be sterilized by radiation, and appearance changed during this procedure, in ways that seemed impossible to predict but made the placebo and active too different from each other! So we had to be super smart and bring our brains with us to the lab. And we had to work in close connection with our international client who worked on scale-up and other partners on ingredient supply and radiation. In less than three weeks we had several new placebo formulations to work with. We also took charge of a panel (one great reason to reside at the university where students are in abundance) and collaborated with experts in statistics to move the project to a fast lane.
Fast lane indeed. The pre-summer panic in our clients voice turned into late-summer cheers when we opened the Champagne for them! Another great product might get out there, and we had some effect on it all. The placebo effect is always there so make sure to account for it also in budget and timings!