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Systematic bias between blinded independent central review and local assessment: literature review and analyses of 76 phase III randomised controlled trials in 45 688 patients with advanced solid tumour.

Jianrong ZhangYiyin ZhangShiyan TangLong JiangQihua HeLindsey Tristine HamblinJiaxi HeZhiheng XuJieyu WuYaoqi ChenHengrui LiangDifei ChenYu HuangXinyu WangKexin DengShuhan JiangJiaqing ZhouJiaxuan XuXuanzuo ChenWenhua LiangJianxing He
Published in: BMJ open (2018)
No systematic bias could be found between local and central assessments in phase III RCTs on solid tumours. However, statistically inconsistent inferences could be made in many trials between both assessments.
Keyphrases
  • phase iii
  • open label
  • placebo controlled
  • clinical trial
  • double blind
  • phase ii
  • case report
  • study protocol