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Annals of Oncology 15:1267-1273, 2004
© 2004 European Society for Medical Oncology

The difference between study recommendations, stated policy, and actual practice in a clinical trial

Background: We determined whether physicians involved in a clinical trial adhere to the study recommendations or the stated policy of their treatment centre with respect to the administration of boost radiation after breast conserving surgery.

Patients and methods: Boost radiation treatment policy was determined by survey at 25 oncology centres involved in a randomised trial of breast or breast plus nodal radiation in Canada. Actual practice was compared with stated policy and study recommendations.

Results: Among 248 subjects, 201 (81%) were treated according to stated policy [{kappa}=0.40, 95% confidence intervals (CI) 0.27–0.52; P<0.0001], indicating only a fair to moderate agreement between stated and actual practice, while 232 (94%) were treated according to study recommendations ({kappa}=0.59, 95% CI 0.40–0.77; P<0.0001), indicating moderate to near substantial agreement between study recommendations and actual practice (P=0.88 for z-test of difference). In a multivariate analysis, subjects who had invasive disease at a resection margin were more likely to get a boost than those with margins clear of invasive tumour by 2 mm [odds ratio (OR) 49, 95% CI 7.6–322; P<0.0001].

Conclusions: Physicians appear compliant with study recommendations for a non-randomised manoeuvre in a clinical trial, possibly at the expense of compliance with stated local policy. Clinical trial protocols should incorporate standard practice.

J. R. Goffin1,*, C. Savage1, D. Tu1, L. Shepherd1, T. J. Whelan2 and I. A. Olivotto3

1 National Cancer Institute of Canada, Clinical Trials Group, Kingston, Ontario; 2 Juravinski Cancer Centre and McMaster University, Hamilton, Ontario; 3 Radiation Therapy Programme, British Columbia Cancer Agency–Vancouver Island Centre, Victoria, BC, Canada

* Correspondence to: Dr J. R. Goffin Tufts-New England Medical Centre, 750 Washington Street, T-NEMC No. 245, Boston, MA 02111, USA. Tel: +1-617-636-5627; Fax: +1-617-636-2342; Email: jgoffin{at}tufts-nemc.org

Key words: clinical trials, data collection, radiotherapy


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