title: Impact of NCI-mandated scientific review on protocol development and content.
abstract: OBJECTIVE
  The NCI requirement that clinical trials at NCI-designated cancer centers undergo scientific review in addition to Institutional Review Board review is unique among medical specialties. We evaluated the impact of this process on protocol development and content.
  
  
  METHODS
  We analyzed cancer clinical trials that underwent full board review by the Harold C. Simmons Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, and protocol modifications using Chi-square testing, Fishers exact testing, and logistic regression.
  
  
  RESULTS
  A total of 226 trials were analyzed. Of these, 77% were industry-sponsored and 23% were investigator-initiated. Initial PRMC decisions were: approval (40%), provisional approval (52%), deferral (7%), and disapproval (1%). These decisions were associated with study sponsor (P<.001) and phase (P<.001). Ultimately, 97% of industry-sponsored and 90% of investigator-initiated trials were approved (P=.05). Changes were requested for 27% of industry-sponsored trials compared with 54% of investigator-initiated trials (P<.001). Total changes requested (mean, 5.6 vs 2.4; P<.001) and implemented (mean, 4.6 vs 2.1; P=.008) per protocol were significantly greater for investigator-initiated trials. Changes related to study design were more commonly requested (35% vs 13% of trials) and implemented (40% vs 5% of trials) for investigator-initiated trials compared with industry-sponsored trials (P=.03).
  
  
  CONCLUSIONS
  NCI-mandated scientific protocol review seems to have a substantial impact on investigator-initiated trials but less effect on industry-sponsored trials. These findings may provide guidance on development and prioritization of institutional protocol review policies.
authors: From School of Medicine, Harold C. Simmons Cancer Center, Department of Clinical Sciences, and Department of Internal Medicine, Division of Hematology-Oncology, University of Texas Southwestern Medical Center, Dallas, Texas.
authors: Ning
authors: N
authors: Ning
authors: From School of Medicine, Harold C. Simmons Cancer Center, Department of Clinical Sciences, and Department of Internal Medicine, Division of Hematology-Oncology, University of Texas Southwestern Medical Center, Dallas, Texas.
authors: Jingsheng
authors: J
authors: Yan
authors: From School of Medicine, Harold C. Simmons Cancer Center, Department of Clinical Sciences, and Department of Internal Medicine, Division of Hematology-Oncology, University of Texas Southwestern Medical Center, Dallas, Texas. From School of Medicine, Harold C. Simmons Cancer Center, Department of Clinical Sciences, and Department of Internal Medicine, Division of Hematology-Oncology, University of Texas Southwestern Medical Center, Dallas, Texas.
authors: Xian-Jin
authors: XJ
authors: Xie
authors: From School of Medicine, Harold C. Simmons Cancer Center, Department of Clinical Sciences, and Department of Internal Medicine, Division of Hematology-Oncology, University of Texas Southwestern Medical Center, Dallas, Texas. From School of Medicine, Harold C. Simmons Cancer Center, Department of Clinical Sciences, and Department of Internal Medicine, Division of Hematology-Oncology, University of Texas Southwestern Medical Center, Dallas, Texas.
authors: David E
authors: DE
authors: Gerber
mesh_terms: D026683:Advisory Committees; D035843:Biomedical Research / Q000191:economics / Q000592:standards*; D002985:Clinical Protocols / Q000592:standards*; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards* / Q000706:statistics & numerical data; D033161:Government Regulation; D006801:Humans; D007221:Industry / Q000191:economics; D054547:National Cancer Institute (U.S.) / Q000331:legislation & jurisprudence; D009369:Neoplasms / Q000628:therapy*; D012107:Research Design / Q000592:standards; D012109:Research Support as Topic; D014481:United States