Table 1. Key issues with trials of antidepressant use in children for depression and the role of the TRS.

Key Issue	Relevant TRS Component	Comment
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
	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
	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