Friday, February 3, 2023

Tag: clinicaltrials.gov

Outcome Reporting Bias in Antipsychotic Medication Trials

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A new study in the journal Translational Psychiatry, an influential journal in biological psychiatry published by Nature, challenges the state of the research on antipsychotic drugs.

Study 329: By the Standards of the Time

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The controversy over “Study 329” on the effects of Paxil in teen depression has raised questions about the state of ALL medical research. I decided to look at the research for the most recent psychiatric drug approved by the FDA, a new antipsychotic called cariprazine or Vraylar.  I located twenty studies of Vraylar on www.ClinicalTrials.gov, the U.S. government-sponsored registry for clinical trials.  Three were still in process, and seventeen were completed.  Not one had shared its results on the government website, a supposedly mandatory step.

“Registered Clinical Trials Make Positive Findings Vanish”

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A study in PLoS One shows that the number of National Heart Lung, and Blood Institute (NHLBI) funded drug trials reporting positive results declined precipitously after the implementation of the clinicaltrials.gov registry, which requires researchers to record their trial methods and outcome measures before collecting data. Of the 55 studies examined, 57% percent of those published before the implementation of clinicaltrials.gov in 2000 yielded a positive result. After 2000, only eight percent of trials claimed a significant benefit to the intervention examined.