At first glance, it seems like the bottom line is "there's no publication bias in this field. But how can you study publication bias if you look only at studies that are published. What about the UNpublished studies? #PLOSONE dx.plos.org/10.1371/journa…
To be fair, they report having looked at study registrations. But it says they searched "clinicaltrials.com" (vs ".gov"), which is the URL for PPD, a contract research organization (CRO) that does Pharma trials. I hope this was a typo.
And they report having looked at funded studies, another good way of establishing an "inception cohort" of trials. They report finding zero unpublished studies. This seems almost too good to be true...
In our study of NIH-funded psychotherapy trials for depression, we found 1/4 of these trials weren't published journals.plos.org/plosone/articl…
Maybe this is due to the fields being different. If it's true that 527 studies were conducted and 527 were published, then that's amazingly good.
But even then, it doesn't tell us about outcome reporting bias. (We couldn't do that, either, in our paper on psychotherapy trials.) To determine that, you have to compare the results in the publications w/ results in a gold standard source.
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This seems a bit fishy. The graph of change in the primary outcome shows that real separation between pimavanserin and placebo occurs ONLY at Day 43 (6 weeks). Seems convenient that this is the primary outcome date. Were they geniuses, or was that time point cherry-picked?
we showed an abysmal lack of transparency in the reporting of antidepressant trials.
Half of the trials were positive (P<0.05 on 1º outcome) & half were negative. But you never wd hv known it from the publ'd lit
Of course the positive trials were published transparently. But negative studies? Either swept under the rug, never to see the light of day, or spun from negative to positive. Thus the avg reader of psych journals was given the impression that antidepressants always beat placebo
“approving drugs for which benefits have not been established can derail scientific progress, expose patients to medications with risks that outweigh benefits, and allow hope to be exploited for commercial benefit, with high costs to the health care system.”
“Unfortunately, patient desperation in the face of crushing realities has no bearing on a drug’s effectiveness against disease; wanting a drug to work does not mean it will.”
“In recent years, under steady pressure from the pharmaceutical industry and the patient groups it funds, the F.D.A. has progressively lowered its standards of effectiveness and safety required for drug approvals.” via @nytopinion @akesselheim nytimes.com/2021/06/15/opi…
“…reached a low point last week when the F.D.A. approved aducanumab, a treatment for Alzheimer’s disease that has not been convincingly shown to work and can cause brain swelling and hemorrhage.”
“more than half of new drugs are now approved based on what’s called surrogate endpoints — changes in the body measured by lab tests that may not reflect clinical benefit — rather than requiring that the drug affect how a person feels, functions or survives.”