Recruitment rates and factors affecting recruitment for a clinical trial of a putative anti-psychotic agent in the treatment of acute schizophrenia
✍ Scribed by Joanna Bowen; Steven Hirsch
- Publisher
- John Wiley and Sons
- Year
- 1992
- Tongue
- English
- Weight
- 424 KB
- Volume
- 7
- Category
- Article
- ISSN
- 0885-6222
No coin nor oath required. For personal study only.
✦ Synopsis
Prospectively collected data on screening of 166 patients for a placebo controlled double blind clinical trial of a putative anti-psychotic drug was analyzed to establish the rate of recruitment of patients in an academic centre known for its interest in schizophrenia and its associated hospitals. Screening of patients was carried out intensively. A descriptive analysis was carried out on why otherwise eligible patients did not consent to enter the trial, and on why patients were not eligible to be entered, either because of physical or psychiatric morbidity. Social demography and morbidity were compared between the subgroups of consenting and non consenting eligible patients. No differences were detected between the demography and morbidity level of the consenters and non-consenters. Nearly 60 per cent of patients screened were ineligible to enter the trial. Reasons for ineligibility are discussed. Of patients eligible 66 per cent were not willing or able to give their consent. This meant that overall, about 1 in 7 of all patients screened were able to be entered into the trial.