1 Boring Old Man

Use the active voice.
The active voice is usually more direct and vigorous than the passive:
     I shall always remember my first visit to Boston.
This is much better than
     My first visit to Boston will always be remembered by me.
The latter sentence is less direct, less bold, and less concise. If the writer tries to make it more concise by omitting "by me,"
     My first visit to Boston will always be remembered,
it becomes indefinite: is it the writer, or some person undisclosed, or the world at large, that will always remember this visit?

One encounters patients who appear to live their lives in the domain of the passive voice. Things just happen in the world. Things happen to them [usually bad or disappointing things], but there’s no agent causing them. And invariably, they leave out their own participation in the things that happen. This was once known as the Fate Neurosis. While it may keep them from blaming others, or keep them from shouldering blame themselves, it’s part of a long-suffering view of life that has a sticky persistence that maintains their dysphoria [and often drives their therapists and acquaintances to distraction]. One of the goals of their psychotherapy is to help them see their own part in making things happen, even if it’s negative – to help them see a world in which they are actors rather than victims of obscure forces like fate, destiny, or bad luck. Whodunit? is of major importance in understanding anything that happens to these people [often times theydunit].

Oddly, my mind goes down this path when reading some of the language used to describe the various sources of bias in Clinical Trial reporting. There’s a long-suffering quality to the lamentations, as if we are victims of a maleficant  universe. It’s in the language we use. Publication Bias refers to trials with unfavorable outcomes that don’t get published. That italicized phrase happens to be an example of the use of the passive voice in that the actor who didn’t publish the study is missing in action – literally. Selective Reporting? Somebody did the selecting. And so it goes. The culprit isn’t in the language. All these sheenanigans that have so garbled our Clinical Trial literature aren’t mistakes, or sloppiness, or something overlooked, or random acts of a perverse deity. They’re not coming from incompetent or poorly trained statisticians. They’re the conscious, motivated acts of a person or persons who’ve got something very specific in mind. And again, the important question is whodunit?

We all know that these distorted trial reports are motivated actions. The goal is to exaggerate efficacy and downplay toxicity, to sell these drugs, but that knowledge doesn’t make it into our descriptive language or our policies. We routinely relate to them in the passive voice, but then wrack our brains trying to think up things that might respond to their happening rather than stopping people from doing them in the first place. We request minimal information and give industry a long time to provide it. Then we don’t levy fines when the required information doesn’t show up. We lament the things that are happening and rarely go after the agents except to extract inadequate fines long after the fact. Many say it won’t stop until we start sending people to prison, but that just hasn’t happened, in part because it’s so difficult to prosecute and often impossible to prove.

Instead of chasing instances where various biases have colored  the reported results after the fact, we could face the reality that distortion and non-compliance are the the expected response. The a priori protocol and declared outcome variables are unlikely to be available a priori. So we could say that no trial can begin until the outcome variables are posted in the registration section on ClinicalTrials.gov. Why not? They’re already available from the Institutional Review Board submission. Similarly, we could say no FDA review of an NDA will be initiated until the Results Database is publicly available filled out on ClinicalTrials.gov for all submitted trials. Why not? They’re being submitted to the FDA so they’re available. Why not submit them to the rest of us?