Literature DB >> 29270062

Identifying barriers to accrual in radiation oncology randomized trials.

J M Laba1, S Senan2, D Schellenberg3, S Harrow4, L Mulroy5, S Senthi6, A Swaminath7, N Kopek8, J R Pantarotto9, L Pan10, A Pearce11, A Warner1, A V Louie1,12, D A Palma1,12.   

Abstract

BACKGROUND: Data 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.
METHODS: Investigators 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.
RESULTS: On 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).
CONCLUSIONS: The 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.

Entities:  

Keywords:  Oligometastases; accrual; clinical trials; stereotactic radiotherapy

Year:  2017        PMID: 29270062      PMCID: PMC5736492          DOI: 10.3747/co.24.3662

Source DB:  PubMed          Journal:  Curr Oncol        ISSN: 1198-0052            Impact factor:   3.677


  11 in total

Review 1.  Factors influencing inclusion of patients with malignancies in clinical trials.

Authors:  Caroline Tournoux; Sandrine Katsahian; Sylvie Chevret; Vincent Levy
Journal:  Cancer       Date:  2006-01-15       Impact factor: 6.860

2.  Definitive Stereotactic Body Radiotherapy (SBRT) for Extracranial Oligometastases: An International Survey of >1000 Radiation Oncologists.

Authors:  Stephen L Lewis; Sandro Porceddu; Naoki Nakamura; David A Palma; Simon S Lo; Peter Hoskin; Drew Moghanaki; Steven J Chmura; Joseph K Salama
Journal:  Am J Clin Oncol       Date:  2017-08       Impact factor: 2.339

Review 3.  Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials.

Authors:  Carol A Townsley; Rita Selby; Lillian L Siu
Journal:  J Clin Oncol       Date:  2005-05-01       Impact factor: 44.544

4.  A survey of stereotactic body radiotherapy use in the United States.

Authors:  Hubert Pan; Daniel R Simpson; Loren K Mell; Arno J Mundt; Joshua D Lawson
Journal:  Cancer       Date:  2011-03-15       Impact factor: 6.860

Review 5.  Obstacles to participation in randomised cancer clinical trials: a systematic review of the literature.

Authors:  Melissa M Grand; Peter C O'Brien
Journal:  J Med Imaging Radiat Oncol       Date:  2012-02       Impact factor: 1.735

Review 6.  Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors.

Authors:  Edward J Mills; Dugald Seely; Beth Rachlis; Lauren Griffith; Ping Wu; Kumanan Wilson; Peter Ellis; James R Wright
Journal:  Lancet Oncol       Date:  2006-02       Impact factor: 41.316

7.  Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from U.S. Cooperative Oncology Groups.

Authors:  Anneke T Schroen; Gina R Petroni; Hongkun Wang; Monika J Thielen; Robert Gray; Jacqueline Benedetti; Xiaofei F Wang; Daniel J Sargent; Donald L Wickerham; Walter Cronin; Benjamin Djulbegovic; Craig L Slingluff
Journal:  Clin Cancer Res       Date:  2011-10-05       Impact factor: 12.531

8.  A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies.

Authors:  Steven K Cheng; Mary S Dietrich; David M Dilts
Journal:  Clin Cancer Res       Date:  2010-11-09       Impact factor: 12.531

9.  Stereotactic ablative radiotherapy for comprehensive treatment of oligometastatic tumors (SABR-COMET): study protocol for a randomized phase II trial.

Authors:  David A Palma; Cornelis J A Haasbeek; George B Rodrigues; Max Dahele; Michael Lock; Brian Yaremko; Robert Olson; Mitchell Liu; Jason Panarotto; Gwendolyn H M J Griffioen; Stewart Gaede; Ben Slotman; Suresh Senan
Journal:  BMC Cancer       Date:  2012-07-23       Impact factor: 4.430

10.  Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study.

Authors:  Shelley Potter; Nicola Mills; Simon J Cawthorn; Jenny Donovan; Jane M Blazeby
Journal:  Trials       Date:  2014-03-14       Impact factor: 2.279

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