Schizophrenia trial participation: perceived inclusion barriers and beliefs about antipsychotics

Pharmacopsychiatry. 2011 Jun;44(4):123-8. doi: 10.1055/s-0031-1277147. Epub 2011 Jun 27.

Abstract

Background: Patient recruitment is the universal rate-limiting factor for randomized controlled trials (RCTs) in all medical specialties. This study examined the opinions on perceived inclusion barriers and beliefs about antipsychotics of a group of psychiatrists participating in a pragmatic RCT on antipsychotic drugs in schizophrenia (the GiSAS trial).

Methods: A survey of all clinicians working in the trial recruiting centers was performed exploring factors associated to the respondents' opinions.

Results: Of 465 clinicians, 278 (59.8%) responded to the questionnaire. Respondents (n=278) were mainly influenced by clinical and trial-related barriers (89%). Factors such as work setting and antipsychotic prescription choices appeared to be related to perceived inclusion barriers. Most respondents believed in the superiority of SGAs (62.9%), one-third indicating drug company representatives as the most important source of information; this was related to further optimism towards SGAs.

Conclusions: Respondents were affected mainly by system-related barriers, whereas personal barriers were given less weight. The influence of industry-mediated information could have affected opinions on SGAs and the lack of uncertainty about antipsychotics attitudes towards trial participation.

Trial registration: ClinicalTrials.gov NCT01052389.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antipsychotic Agents / therapeutic use*
  • Attitude of Health Personnel*
  • Biomedical Research / organization & administration
  • Drug Industry / methods
  • Drug Information Services
  • Drug Labeling
  • Female
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Patient Selection*
  • Physicians / psychology*
  • Practice Patterns, Physicians'
  • Research Personnel / psychology*
  • Schizophrenia / drug therapy*
  • Surveys and Questionnaires
  • Workplace / psychology

Substances

  • Antipsychotic Agents

Associated data

  • ClinicalTrials.gov/NCT01052389