Clinical trial registration: a statement from the International Committee of Medical Journal Editors

Angelis, Catherine De; Drazen, Jeffrey M.; Frizelle, Frank; Haug, Charlotte; Hoey, John; Horton, Richard; Kotzin, Sheldon; Lainé, Christine; Marušić, Ana; Overbeke, A. John P.M.; Schroeder, Torben V.; Sox, Hal C.; Weyden, Martin B Van Der

doi:10.1016/s0140-6736(04)17034-7

Cited by 533 publications

(511 citation statements)

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“…Trial registration [40] should diminish overt publication bias, but “negative” results may still be published later than “positive” results [41–43]. This time-lag may distort the literature for many years, enough time for a drug to carry its market share.…”

Section: Odds Of Truth For Clinical Trialsmentioning

confidence: 99%

Evolution and Translation of Research Findings: From Bench to Where

Ioannidis¹

2006

PLOS Clin Trial

115

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Section: Odds Of Truth For Clinical Trialsmentioning

confidence: 99%

Evolution and Translation of Research Findings: From Bench to Where

Ioannidis¹

2006

PLOS Clin Trial

115

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“…Journal editors are becoming increasingly aware of how they are being manipulated and are fighting back [17,18], but I must confess that it took me almost a quarter of a century editing for the BMJ to wake up to what was happening. Editors work by considering the studies submitted to them.…”

Section: Peer Review Doesn't Solve the Problemmentioning

confidence: 99%

“…Editors can review protocols, insist on trials being registered, demand that the role of sponsors be made transparent, and decline to publish trials unless researchers control the decision to publish [17,18]. I doubt, however, that these steps will make much difference.…”

Section: Journals Should Critique Trials Not Publish Themmentioning

confidence: 99%

Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies

Smith¹

2005

PLoS Med

407

268

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“…While it may not be possible to provide all “negative” results in detail, the reader should be aware of the existence of these analyses that have led to “negative” results. This is fairly challenging because, in contrast with randomized trials [38], upfront registration of epidemiological protocols may be very difficult or unrealistic. Some epidemiological research will unavoidably remain exploratory and post hoc in nature.…”

Section: Discussionmentioning

confidence: 99%

Selection in Reported Epidemiological Risks: An Empirical Assessment

2007

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BackgroundEpidemiological studies may be subject to selective reporting, but empirical evidence thereof is limited. We empirically evaluated the extent of selection of significant results and large effect sizes in a large sample of recent articles.Methods and FindingsWe evaluated 389 articles of epidemiological studies that reported, in their respective abstracts, at least one relative risk for a continuous risk factor in contrasts based on median, tertile, quartile, or quintile categorizations. We examined the proportion and correlates of reporting statistically significant and nonsignificant results in the abstract and whether the magnitude of the relative risks presented (coined to be consistently ≥1.00) differs depending on the type of contrast used for the risk factor. In 342 articles (87.9%), ≥1 statistically significant relative risk was reported in the abstract, while only 169 articles (43.4%) reported ≥1 statistically nonsignificant relative risk in the abstract. Reporting of statistically significant results was more common with structured abstracts, and was less common in US-based studies and in cancer outcomes. Among 50 randomly selected articles in which the full text was examined, a median of nine (interquartile range 5–16) statistically significant and six (interquartile range 3–16) statistically nonsignificant relative risks were presented (p = 0.25). Paradoxically, the smallest presented relative risks were based on the contrasts of extreme quintiles; on average, the relative risk magnitude was 1.41-, 1.42-, and 1.36-fold larger in contrasts of extreme quartiles, extreme tertiles, and above-versus-below median values, respectively (p < 0.001).ConclusionsPublished epidemiological investigations almost universally highlight significant associations between risk factors and outcomes. For continuous risk factors, investigators selectively present contrasts between more extreme groups, when relative risks are inherently lower.

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Clinical trial registration: a statement from the International Committee of Medical Journal Editors

Cited by 533 publications

References 0 publications

Evolution and Translation of Research Findings: From Bench to Where

Evolution and Translation of Research Findings: From Bench to Where

Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies

Selection in Reported Epidemiological Risks: An Empirical Assessment

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