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. 2009 Jan 21;2009(1):MR000006. doi: 10.1002/14651858.MR000006.pub3

Bardy 1998.

Study characteristics
Methods Clinical drug trials notified to the National Agency for Medicine, Finland in 1987. Publication status was obtained by writing to the principal investigator or sponsor of each trial. A MEDLINE search was conducted (1987 ‐ 1995) to identify relevant publications.
Data 188 clinical trials.
Comparisons Publication status of trials with positive findings compared with those with negative or inconclusive findings. Trials were classified as either positive findings, negative or inconclusive findings. P values were not given.
Outcomes Trials with positive findings were more likely to be published than those with negative or null findings.
Total published = 68/188 (36%)
Positive = 52/111 (47%)
Negative = 5/44 (11%)
Inconclusive = 11/33 (33%)
Notes 274 trials were identified of which 188 were included in the analysis. Reasons for exclusion were: ongoing (n = 9); suspended (n = 64); not commenced (n = 17).
Risk of bias
Item Authors' judgement Support for judgement
Inception cohort? Yes "The material consisted of clinical trials on medicinal products notified to the National Agency for Medicines in 1987." (page 147)
Complete follow up of all trials? Yes "With a specific request the status of all but one trial was reported. Of all the 274 trials, 183 were completed, 9 remained ongoing, 64 were suspended and 17 had not commenced." (page 148)
Publication ascertained through personal contact with investigators or sponsor? Yes "The sponsors of non‐reported trials were requested by letter to report the outcome of specified trials" (page 147) ... "A Medline search for 1987‐1995 was conducted to identify any publication based on the trials." (page 148)
Definition of positive and negative findings clearly defined? Unclear "... the terms "better and inferior" refer to the opinion of the investigator, not to the statistical significance. The expression "not clinically significantly different" also refers to the opinion of the investigators, not to robust statistical evaluation of equivalence or non‐inferiority." (page 148)
Possible confounders controlled for in the analysis Unclear No statistical methods are reported have been applied in order to control for possible confounders.