Lack of prospective public information about all trials of Paxil and other selective serotonin reuptake inhibitors (SSRIs) in depressed children |
Prospective Registration |
Registration would have provided a public list of all ongoing and completed trials of Paxil/SSRIs in depressed children |
Alleged suppression of “negative” results from certain Paxil trials in depressed children [22] |
Prospective Registration |
Registration would have allowed the detection of trials without disclosed results |
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Summary Results Reporting |
Results database entries would have provided access to “minimum reporting set” including all prespecified outcome measures and all serious adverse events |
Detection of selective reporting bias of efficacy and safety findings in the published results of Study 329, unacknowledged changes in outcome measures, and other issues [23] |
Prospective Registration |
Archival registration information would have allowed for the detection of unacknowledged changes in prespecified outcome measures and detection of nonprespecified outcome measures reported as statistically significant |
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Summary Results Reporting |
Structured reporting devoid of interpretation or conclusions would have made summary data publicly available while avoiding the possibility of spinning the results |
Invalid and unacknowledged categorization of certain adverse events, resulting in the underreporting of suicidality [24] |
Sharing Highly Granular IPD and Documents (e.g., CRFs) |
Access to high-granularity IPD enabled the elucidation of data analytic decisions that had not been publicly disclosed; reanalysis was possible with different methods of categorizing adverse events |