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letter
. 2020 Jan 4;22(4):577–579. doi: 10.1093/neuonc/noz246

Table 1.

Trial factors associated with complete BMEC

Trial Characteristics No. Trials with Complete BMEC/Total Percent P-valuea
Industry funding of trial Yes 141/361 39.1 P = 0.02
No 27/101 26.7
Cooperative group trial Yes 35/112 31.3 P = 0.20
No 132/348 37.9
Enrollment start year 1995–2000 4/8 50 P  = 0.02
2001–2005 41/90 45.6
2006–2010 96/258 37.2
2011–2015 26/102 25.5
Disease siteb Breast 32/75 42.7 P  < 0.001
Gastrointestinal 43/76 56.6
Genitourinary 35/55 65.5
Head & Neck 4/23 17.4
Melanoma 5/20 25.0
Thoracic 18/95 18.9
Treatment modalityc Systemic therapy 137/334 41.0 P  = 0.01
Radiotherapy 1/6 16.7
Surgery 1/2 50.0
Supportive care 26/112 23.2
Systemic therapy subgroupd Targeted therapy 106/257 41.2 P = 0.88
Cytotoxic chemotherapy 31/77 40.3
Completed planned accrual Yes 90/240 37.5 P = 0.56
No 37/108 34.3
Trial success (primary endpoint met) Yes 72/198 36.4 P = 0.53
No 70/177 39.5

a P-value reflects Pearson’s chi-squared tests for all except enrollment start year, for which P-value reflects results of binary logistic regression analysis by year.

bLimited to trials with a defined single disease site.

cPrimary intervention as part of the randomization. Systemic therapy includes cytotoxic chemotherapy, targeted systemic agents, and similar, with primary endpoint aimed at improved disease-related outcomes. Supportive care trials aimed to reduce disease- or treatment-related toxicity.

dSystemic therapy trials subdivided further into those assessing a targeted therapy (including small molecule inhibitors, monoclonal antibodies, and similar) and those assessing cytotoxic chemotherapy.