The promise before the evidence.
An indicator improves. A curve shifts. The presentation is already speaking the language of a breakthrough. Between that signal and what changes in people’s lives, though, there may be a distance still to be measured.
The FDA distinguishes direct clinical outcomes from surrogate endpoints used to predict a benefit. It also distinguishes levels of surrogate validation. Confusing them turns evidence of differing strength into a single, undifferentiated promise.
There can be serious reasons for making a decision early. Waiting has a cost, particularly when alternatives are few. Uncertainty, however, does not evaporate at the moment of purchase. Someone continues to bear it: the service that pays, the person receiving treatment, those awaiting confirmation of the result.
This raises a concrete economic question: how does the agreement change if the expected benefit fails to materialise? Answering it requires the ability to track outcomes, read the terms and understand how the consequences of error are distributed.
The future is already in the price. The question is whether, when it arrives, we can still hold it to account for the promises made.
Sources and notes
On the distinction between clinical outcomes, surrogates and levels of validation. The economic implications are arguments developed by the blog.