title: The landscape of precision cancer medicine clinical trials in the United States.
abstract: OBJECTIVE
  Advances in tumor biology and multiplex genomic analysis have ushered in the era of precision cancer medicine. Little is currently known, however, about the landscape of prospective "precision cancer medicine" clinical trials in the U.S.
  
  
  METHODS
  We identified all adult interventional cancer trials registered on ClinicalTrials.gov between September 2005 and May 2013. Trials were classified as "precision cancer medicine" if a genomic alteration in a predefined set of 88 genes was required for enrollment. Baseline characteristics were ascertained for each trial.
  
  
  RESULTS
  Of the initial 18,797 trials identified, 9094 (48%) were eligible for inclusion: 684 (8%) were classified as precision cancer medicine trials and 8410 (92%) were non-precision cancer medicine trials. Compared with non-precision cancer medicine trials, precision cancer medicine trials were significantly more likely to be phase II [RR 1.19 (1.10-1.29), p<0.001], multi-center [RR 1.18 (1.11-1.26), p<0.001], open-label [RR 1.04 (1.02-1.07), p=0.005] and involve breast [RR 4.03 (3.49-4.52), p<0.001], colorectal [RR 1.62 (1.22-2.14), p=0.002] and skin [RR 1.98 (1.55-2.54), p<0.001] cancers. Precision medicine trials required 38 unique genomic alterations for enrollment. The proportion of precision cancer medicine trials compared to the total number of trials increased from 3% in 2006 to 16% in 2013.
  
  
  CONCLUSIONS
  The proportion of adult cancer clinical trials in the U.S. requiring a genomic alteration for enrollment has increased substantially over the past several years. However, such trials still represent a small minority of studies performed within the cancer clinical trials enterprise and include a small subset of putatively "actionable" alterations.
authors: Weill Cornell Medical College, New York, NY, United States.
authors: Nitin
authors: N
authors: Roper
authors: Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, New York, NY, United States; Department of Surgery, Lahey Clinic, Burlington, MA, United States; Department of Urology, Lahey Clinic, Burlington, MA, United States.
authors: Kristian D
authors: KD
authors: Stensland
authors: Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, New York, NY, United States.
authors: Ryan
authors: R
authors: Hendricks
authors: Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, New York, NY, United States. Electronic address: Matthew.galsky@mssm.edu.
authors: Matthew D
authors: MD
authors: Galsky
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000639:trends; D006801:Humans; D058990:Molecular Targeted Therapy / Q000379:methods / Q000639:trends; D009369:Neoplasms / Q000188:drug therapy* / Q000235:genetics; D057285:Precision Medicine / Q000379:methods; D014481:United States
keywords: Actionable mutations; Clinical trials; Clinicaltrials.gov; Genomics; Precision cancer medicine; Precision medicine