Too many studies of atypical antipsychotic medications are still not meeting even the minimum scientific standards of the internationally agreed-upon CONSORT guidelines for drug trials, according to a study in Psychological Medicine. The frequently poor trial designs and methods are “potentially impeding the progress of research on antipsychotic efficacy,” stated the team from the Kings College London Institute of Psychiatry.
The researchers conducted a systematic analysis of all phase II and phase III clinical trials of antipsychotic drugs performed between 2006 and 2012. (ClinicalTrials.gov defines phase I trials as those involving testing a new drug in a small group for the first time, whereas phase II and III trials involve testing a drug in larger groups to see if is truly effective and to monitor side effects while comparing it to other commonly used treatments.)
The Kings College London researchers evaluated the antipsychotic trials on the basis of the scientific standards of their trial designs and reporting, assessing them relative to the international Consolidated Standards of Reporting Trials (CONSORT) guidlines. According to its website, CONSORT “offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation.” Their guidelines have been endorsed by hundreds of medical journals.
The researchers evaluated 32 antipsychotic studies in total. “There was insufficient reporting of design in 47% of studies and only 13% explicitly stated a primary hypothesis,” the researchers found. “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.”
In conclusion, the researchers wrote that, “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.”
(Abstract) The quality of reporting of phase II and III trials for new antipsychotics: a systematic review (Patel, M.X. et al. Psychological Medicine. February 2015. DOI: http://dx.doi.org/10.1017/S0033291714001214.)
Question: What are clinical trial phases? (ClinicalTrials.gov)