The quality of reporting of phase II and III trials for new antipsychotics: a systematic review

Maxine X. Patel · Jennifer M. Hellier · Gresha Bhatia · Robin M. Murray

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Meta-analysis and systematic reviews Schizophrenia research and treatment Statistical Methods in Clinical Trials

Abstract

BACKGROUND: The findings of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study and the Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS) called previous trials of antipsychotics into question, including pre-licensing trials. Concerns regarding methodological robustness and quality of reporting increased. This systematic review aimed to examine the quality of reporting of phase II and III trials for new antipsychotics in the aftermath of the CATIE and CUtLASS studies. METHOD: Electronic searches were conducted in EMBASE, Medline and Cochrane databases and also ClinicalTrials.gov for antipsychotic trials (published between January 2006 and February 2012). Phase II and III randomized controlled trials (RCTs) for iloperidone, asenapine, paliperidone, olanzapine, lurasidone and pomaglumetad methionil were selected for schizophrenia and schizoaffective disorder. The reporting of the methodology was evaluated in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines. RESULTS: Thirty-one articles regarding 32 studies were included. There was insufficient reporting of design in 47% of studies and only 13% explicitly stated a primary hypothesis. Exclusion criteria were poorly reported for diagnosis in 22% of studies. Detail regarding comparators, particularly placebos, was suboptimal for 56% of studies, and permitted concomitant medication was often not reported (19%). Randomization methods were poorly described in 56% of studies and reporting on blinding was insufficient in 84% of studies. Sample size calculations were insufficiently reported in 59% of studies. CONCLUSIONS: The quality of reporting of phase II and III trials for new antipsychotics does not reach the standards outlined in the CONSORT guidelines. Authors often fail to adequately report design and methodological processes, potentially impeding the progress of research on antipsychotic efficacy. Both policymakers and clinicians require high quality reporting before decisions are made regarding licensing and prescribing of new antipsychotics.

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References

2010CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials 2010CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials 1976ECDEU Assessment Manual for Psychopharmacology 2001The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials 1996Improving the Quality of Reporting of Randomized Controlled Trials 1996Improving the Quality of Reporting of Randomized Controlled Trials 2004Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement

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