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Old 24-09-2018, 10:05 AM   #97
st jimmy
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Not reporting negative results

In 2008, it was reported that of the 74 FDA-registered studies for 12 antidepressant drugs approved by the FDA between 1987 and 2004: 31% were not published. Whether and how the studies were published depended on the results of the study.
Of the 38 studies that had positive results, according to the FDA – 37 were published (97%).
Of the 36 studies that had negative (24) or questionable (12) results, according to the FDA – only 15 were published (42%).


Of the 15 studies that were published with negative or questionable (no clear result) results, according to the FDA – 11 were manipulated to present a positive outcome (73%).
As a result of simply not publishing negative outcomes or presenting the results in a too positive light, it looked like 94% of the trials conducted were positive. The FDA analysis showed that only 51% were positive.

The positive effects were also often reported as greater than according to the FDA reviews. For each of the 12 drugs, the effect size derived from the “scientific” reports exceeded the effect size concluded by the FDA.

Erick H. Turner et al. – Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy (2008): https://www.nejm.org/doi/full/10.1056/NEJMsa065779


This year, a group led by psychiatrist Goldacre also reported that medical trials often violate EU legal requirements for reporting within a year after completion. In the US and the EU, certain categories of trials have to be reported within 1 year of completion by law.

Of 7274 trials where results were due, only 49.5% reported results in time. While only 68% of company-sponsored trials reporting their results, universities reported only 11%.

Of the 31,818 trials investigated, the study excluded 20,287 and 3392 trials because their status was never reported as completed. It is likely that many of these trials with “missing dates” (inconsistent data) also failed to report results within time.

Ben Goldacre et al. – Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource (2018): https://www.bmj.com/content/362/bmj.k3218

The following site managed by Goldacre gives more details on which companies and universities don’t report in time. Note the huge amount of universities that never report in time (0%).
Also note the huge amount of studies with inconsistent data: http://eu.trialstracker.net/
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Last edited by st jimmy; 24-09-2018 at 10:06 AM.
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