The quality of reporting of phase II and III trials for new antipsychotics: a systematic review
M X Patel1, S Collins1, J Hellier1
1Department of Psychosis Studies, Institute of Psychiatry,King's College London,UK.
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.
Insights
Reporting quality for new antipsychotic trials is poor, failing to meet CONSORT standards. Improved reporting is crucial for clinical decisions on antipsychotic medications.
Area of Science:
- Psychiatry and Pharmaceutical Sciences
- Clinical Trial Methodology
- Evidence-Based Medicine
Background:
- Major antipsychotic trials (CATIE, CUtLASS) raised concerns about prior study quality.
- Methodological robustness and reporting standards for antipsychotic trials were questioned.
- This review assesses reporting quality of recent phase II/III antipsychotic trials.
Purpose of the Study:
- To systematically review the reporting quality of phase II and III trials for new antipsychotic medications.
- To evaluate adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines.
- To identify specific areas of inadequate reporting in recent antipsychotic drug trials.
Main Methods:
- Systematic review of phase II and III randomized controlled trials (RCTs) for specific new antipsychotics.
- Searches conducted in EMBASE, Medline, Cochrane, and ClinicalTrials.gov (Jan 2006 - Feb 2012).
- Evaluation of reporting quality based on CONSORT guidelines.
Main Results:
- Thirty-two studies were included, with significant reporting deficiencies noted.
- Inadequate reporting observed in trial design (47%), primary hypothesis (13%), and exclusion criteria (22%).
- Poor reporting of comparators (56%), concomitant medications (19%), randomization (56%), blinding (84%), and sample size calculations (59%) was prevalent.
Conclusions:
- Reporting quality of new antipsychotic trials does not meet CONSORT standards.
- Inadequate reporting hinders research progress and informed clinical/policy decisions.
- High-quality reporting is essential for licensing and prescribing new antipsychotics.
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