Identifying barriers to accrual in radiation oncology randomized trials

Current oncology

D.A. Palma¹  D. Schellenberg²  S. Harrow³  L. Mulroy⁴  A. Swaminath⁵  A.V. Louie⁶  J.M. Laba⁷  A. Warner⁷  N. Kopek⁸  A. Pearce⁹  L. Pan^1,10  S. Senthi^1,11  J.R. Pantarotto^1,12  S. Senan^1,13 

[1] Western University;BC Cancer Agency;Beatson West of Scotland Cancer Centre;Dalhousie University;Juravinski Cancer Center;London Health Sciences;London Health Sciences Centre;McGill University;Northeast Cancer Centre;Prince Edward Island Cancer Treatment Centre;The Alfred Hospital;University of Ottawa;VU University Medical Centre

关键词: Oligometastases;    stereotactic radiotherapy;    clinical trials;    accrual;   

DOI  :  10.3747/co.24.3662

学科分类：肿瘤学

来源: Multimed, Inc.

【 摘 要 】

BackgroundData about factors driving accrual to radiation oncology trials are limited. In oncology, 30%–40% of trials are considered unsuccessful, many because of poor accrual. The goal of the present study was to inform the design of future trials by evaluating the effects of institutional, clinician, and patient factors on accrual rates to a randomized radiation oncology trial. MethodsInvestigators participating in sabr-comet (NCT01446744), a randomized phase ii trial open in Canada, Europe, and Australia that is evaluating the role of stereotactic ablative radiotherapy (sabr) in oligometastatic disease, were invited to complete a survey about factors affecting accrual. Institutional ethics approval was obtained. The primary endpoint was the annual accrual rate per institution. Univariable and multivariable linear regression analyses were used to identify factors predictive of annual accrual rates. ResultsOn univariable linear regression analysis, off-trial availability of sabr ( p= 0.014) and equipoise of the referring physician ( p= 0.014) were found to be predictive of annual accrual rates. The annual accrual rates were lower when centres offered sabr for oligometastases off-trial (median: 3.7 patients vs. 8.4 patients enrolled) and when referring physicians felt that, compared with having equipoise, sabr was beneficial (median: 4.8 patients vs. 8.4 patients enrolled). Multivariable analysis identified perceived level of equipoise of the referring physician to be predictive of the annual accrual rate ( p= 0.023). ConclusionsThe level of equipoise of referring physicians might play a key role in accrual to radiation oncology randomized controlled trials. Efforts to communicate with and educate referring physicians might therefore be beneficial for improving trial accrual rates.

【 授权许可】

Unknown