title: From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology.
abstract: OBJECTIVE
  The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data.
  
  
  METHODS
  We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses.
  
  
  RESULTS
  A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007).
  
  
  CONCLUSIONS
  Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting.
authors: Kanwal Pratap Singh Raghav, Sminil Mahajan, James C. Yao, Brian P. Hobbs, Donald A. Berry, Alda Tam, Waun K. Hong, Lee M. Ellis, and Michael J. Overman, The University of Texas MD Anderson Cancer Center, Houston, TX; Rebecca D. Pentz, Emory School of Medicine, Atlanta, GA; and James Abbruzzese, Duke Cancer Institute, Durham, NC.
authors: Kanwal Pratap Singh
authors: KP
authors: Raghav
authors: Kanwal Pratap Singh Raghav, Sminil Mahajan, James C. Yao, Brian P. Hobbs, Donald A. Berry, Alda Tam, Waun K. Hong, Lee M. Ellis, and Michael J. Overman, The University of Texas MD Anderson Cancer Center, Houston, TX; Rebecca D. Pentz, Emory School of Medicine, Atlanta, GA; and James Abbruzzese, Duke Cancer Institute, Durham, NC.
authors: Sminil
authors: S
authors: Mahajan
authors: Kanwal Pratap Singh Raghav, Sminil Mahajan, James C. Yao, Brian P. Hobbs, Donald A. Berry, Alda Tam, Waun K. Hong, Lee M. Ellis, and Michael J. Overman, The University of Texas MD Anderson Cancer Center, Houston, TX; Rebecca D. Pentz, Emory School of Medicine, Atlanta, GA; and James Abbruzzese, Duke Cancer Institute, Durham, NC.
authors: James C
authors: JC
authors: Yao
authors: Kanwal Pratap Singh Raghav, Sminil Mahajan, James C. Yao, Brian P. Hobbs, Donald A. Berry, Alda Tam, Waun K. Hong, Lee M. Ellis, and Michael J. Overman, The University of Texas MD Anderson Cancer Center, Houston, TX; Rebecca D. Pentz, Emory School of Medicine, Atlanta, GA; and James Abbruzzese, Duke Cancer Institute, Durham, NC.
authors: Brian P
authors: BP
authors: Hobbs
authors: Kanwal Pratap Singh Raghav, Sminil Mahajan, James C. Yao, Brian P. Hobbs, Donald A. Berry, Alda Tam, Waun K. Hong, Lee M. Ellis, and Michael J. Overman, The University of Texas MD Anderson Cancer Center, Houston, TX; Rebecca D. Pentz, Emory School of Medicine, Atlanta, GA; and James Abbruzzese, Duke Cancer Institute, Durham, NC.
authors: Donald A
authors: DA
authors: Berry
authors: Kanwal Pratap Singh Raghav, Sminil Mahajan, James C. Yao, Brian P. Hobbs, Donald A. Berry, Alda Tam, Waun K. Hong, Lee M. Ellis, and Michael J. Overman, The University of Texas MD Anderson Cancer Center, Houston, TX; Rebecca D. Pentz, Emory School of Medicine, Atlanta, GA; and James Abbruzzese, Duke Cancer Institute, Durham, NC.
authors: Rebecca D
authors: RD
authors: Pentz
authors: Kanwal Pratap Singh Raghav, Sminil Mahajan, James C. Yao, Brian P. Hobbs, Donald A. Berry, Alda Tam, Waun K. Hong, Lee M. Ellis, and Michael J. Overman, The University of Texas MD Anderson Cancer Center, Houston, TX; Rebecca D. Pentz, Emory School of Medicine, Atlanta, GA; and James Abbruzzese, Duke Cancer Institute, Durham, NC.
authors: Alda
authors: A
authors: Tam
authors: Kanwal Pratap Singh Raghav, Sminil Mahajan, James C. Yao, Brian P. Hobbs, Donald A. Berry, Alda Tam, Waun K. Hong, Lee M. Ellis, and Michael J. Overman, The University of Texas MD Anderson Cancer Center, Houston, TX; Rebecca D. Pentz, Emory School of Medicine, Atlanta, GA; and James Abbruzzese, Duke Cancer Institute, Durham, NC.
authors: Waun K
authors: WK
authors: Hong
authors: Kanwal Pratap Singh Raghav, Sminil Mahajan, James C. Yao, Brian P. Hobbs, Donald A. Berry, Alda Tam, Waun K. Hong, Lee M. Ellis, and Michael J. Overman, The University of Texas MD Anderson Cancer Center, Houston, TX; Rebecca D. Pentz, Emory School of Medicine, Atlanta, GA; and James Abbruzzese, Duke Cancer Institute, Durham, NC.
authors: Lee M
authors: LM
authors: Ellis
authors: Kanwal Pratap Singh Raghav, Sminil Mahajan, James C. Yao, Brian P. Hobbs, Donald A. Berry, Alda Tam, Waun K. Hong, Lee M. Ellis, and Michael J. Overman, The University of Texas MD Anderson Cancer Center, Houston, TX; Rebecca D. Pentz, Emory School of Medicine, Atlanta, GA; and James Abbruzzese, Duke Cancer Institute, Durham, NC.
authors: James
authors: J
authors: Abbruzzese
authors: Kanwal Pratap Singh Raghav, Sminil Mahajan, James C. Yao, Brian P. Hobbs, Donald A. Berry, Alda Tam, Waun K. Hong, Lee M. Ellis, and Michael J. Overman, The University of Texas MD Anderson Cancer Center, Houston, TX; Rebecca D. Pentz, Emory School of Medicine, Atlanta, GA; and James Abbruzzese, Duke Cancer Institute, Durham, NC. moverman@mdanderson.org.
authors: Michael J
authors: MJ
authors: Overman
mesh_terms: D019317:Evidence-Based Medicine; D006801:Humans; D008495:Medical Oncology / Q000379:methods*; D009369:Neoplasms / Q000628:therapy*; D063868:Patient Outcome Assessment; D010506:Periodicals as Topic; D017594:Publication Bias; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D016896:Treatment Outcome