Large simple trials in psychiatry: providing reliable answers to important clinical questions

Risk Factors for Violence in Psychosis: Systematic Review and Meta-Regression Analysis of 110 Studies

“…These dynamic factors include: hostile behaviour, poor impulse control, lack of insight, general symptom scores, recent alcohol and/or drug misuse, and nonadherence with psychological therapies and medication. The potential contribution of addressing these factors would benefit from further examination in larger observational studies and large simple clinical trials [73] in which violence is a primary outcome. …”

Unmet needs in paediatric psychopharmacology: Present scenario and future perspectives

“…Data collected in adults suggest that RCTs may overestimate the effect size of clinical benefits produced by the active experimental drug, as compared to observational studies (Naudet et al, 2011;Wisniewski et al, 2009). This concern is not new, and it has been generally agreed that traditional RCTs, which establish initial efficacy, should then be followed by practical trials ("large simple trials"), in order to evaluate effectiveness in practice settings (Geddes, 2005). However, few practical trials have been conducted in paediatric psychopharmacology, primarily due to funding limitations and lack of appropriate logistic infrastructure.…”

Meta-analysis in the assessment of treatment outcome

“…To do so, first we need to adhere to sound scientific principles for the analysis and reporting of subgroup analyses. In the long-term, one answer will be in larger trials in psychiatry (Geddes and Goodwin, 2001;Geddes, 2005). An immediate partial solution is offered, however, by meta-analysis and especially by meta-analysis of individual patient data.…”