Examples of benefit-risk assessments comparing antipsychotic treatments

2 publications on using BRAT and DCE in the same setting

Levitan et al and Katz et al have recently published research on the comparison of treatments against schizophrenia. Both papers are available under open access. Levitan et al. report on a clinical study results from two similar placebo controlled studies. The indirect comparison was not done via a classical Bucher method but using IPD data as described in Markowitz et al (2013) which also contains the basis for this post-hoc analyses. Levitan et al performed a post-hoc benefit-risk assessment using the Benefit-Risk Action Team framework. The key benefits and risks are reported using a value tree. The benefit-risk assessment differentiates between short term (8 weeks) and long term (40 weeks) outcomes. For both time points similar effects tables and associated plots are provided, that display the events per 1000 patients and the response or risk differences with 95% confidence intervals. Continuous outcomes like PANSS and CGI-S as well as weight increases were dichotomized using common criteria.

In a related paper Katz et al describe how patients and physicians in these clinical trials quantified preferences related to benefits and risks of antipsychotic treatments. Via the used discrete choice experiment, the authors assess the impact of prior patient adherence on the relative importance of treatment efficacy and formulation. This publication shows a nice incorporation of such a preference study within clinical trials and might be the first time, that such a DCE as successfully implemented in such a trial.

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