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Representation and outcomes of individuals with schizophrenia seen in everyday practice who are ineligible for randomized clinical trials

JAMA Jan 30, 2022

As randomized clinical trials (RCTs) generating evidence concerning efficacy and safety of antipsychotics in schizophrenia spectrum disorders represent only a part of the real-world population (i.e. unselected patients seen in everyday clinical practice) owing to their strict eligibility criteria, researchers herein investigated the percentage of patients with schizophrenia in the real world represented in randomized clinical trials (RCTs) and examined if their outcomes differ from those not represented in RCTs.

  • Researchers studied data of a total of 25,259 real-world individuals with diagnoses of schizophrenia spectrum disorders that were recorded in national patient registries in Finland and Sweden.

  • Analysis revealed that nearly a fifth of the patients were represented in RCTs and better outcomes were recorded for these individuals compared with those not meeting RCT inclusion criteria.

  • Based on findings, researchers recommend considering the heterogeneity of individuals with schizophrenia and the patient groups typically ineligible for participation in future research; by representing a broader spectrum of individuals with schizophrenia and by targeting specific currently underrepresented groups, RCTs may become more inclusive.

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