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The selection of cases for randomised trials : a registry survey of concurrent trial and non-trial patients
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Ward, L. C., Fielding, J. W. L. and Dunn, Janet A. (1992) The selection of cases for randomised trials : a registry survey of concurrent trial and non-trial patients. British Journal of Cancer, 66 (5). pp. 943-950. doi:10.1038/bjc.1992.390
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Official URL: https://doi.org/10.1038/bjc.1992.390
Abstract
A randomised trial of adjuvant chemotherapy vs placebo in operable stomach cancer recruited 249
patients from the West Midlands Region between 1976-1980. A Cancer Registry survey identified a further
1261 suitable concurrent cases. Trial patients were compared with the 960 non-trial cases from participating
Districts. Only 493 (51%) non-trial cases passed all of the prospective trial selection criteria for entry. Stage
and fitness caused the majority of exclusions and were also highly prognostic. A univariate analysis comparing eligible patients with the trial showed the two groups to be balanced for the
significant independent prognostic factors of the trial. However, differences in patient age and the surgery
performed indicate that recruitment may have been influenced by unknown selection factors. This survey
highlights the difficulty of retrospective selection and confirms the need for randomised controls. Data
available from specialist Registries may be used to help develop new protocols and to verify and extend trial
results.
| Item Type: | Journal Article | ||||
|---|---|---|---|---|---|
| Subjects: | R Medicine > R Medicine (General) | ||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Journal or Publication Title: | British Journal of Cancer | ||||
| Publisher: | Nature Publishing Group | ||||
| ISSN: | 0007-0920 | ||||
| Official Date: | 1 November 1992 | ||||
| Dates: |
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| Volume: | 66 | ||||
| Number: | 5 | ||||
| Page Range: | pp. 943-950 | ||||
| DOI: | 10.1038/bjc.1992.390 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access |
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