TY - JOUR AU - Edwards, I. R. AU - Biriell, C. PY - 1994 DA - 1994// TI - Harmonisation in pharmacovigilance JO - Drug Saf VL - 10 UR - https://doi.org/10.2165/00002018-199410020-00001 DO - 10.2165/00002018-199410020-00001 ID - Edwards1994 ER - TY - BOOK PY - 1994 DA - 1994// TI - ICH Harmonised Tripartite Guideline. E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting ID - ref2 ER - TY - JOUR AU - O'Neill, R. T. PY - 2002 DA - 2002// TI - Regulatory perspectives on data monitoring JO - Stat Med VL - 21 UR - https://doi.org/10.1002/sim.1287 DO - 10.1002/sim.1287 ID - O'Neill2002 ER - TY - JOUR AU - Phillips, R. AU - Hazell, L. AU - Sauzet, O. AU - Cornelius, V. PY - 2019 DA - 2019// TI - Analysis and reporting of adverse events in randomised controlled trials: a review JO - BMJ Open VL - 9 UR - https://doi.org/10.1136/bmjopen-2018-024537 DO - 10.1136/bmjopen-2018-024537 ID - Phillips2019 ER - TY - JOUR AU - Seltzer, J. H. AU - Li, J. AU - Wang, W. PY - 2019 DA - 2019// TI - Interdisciplinary safety evaluation and quantitative safety monitoring: introduction to a series of papers JO - Ther Innov Regul Sci VL - 0 ID - Seltzer2019 ER - TY - JOUR AU - Ioannidis, J. A. AU - Evans, S. W. AU - Gøtzsche, P. C. PY - 2004 DA - 2004// TI - Better reporting of harms in randomized trials: an extension of the consort statement JO - Ann Intern Med VL - 141 UR - https://doi.org/10.7326/0003-4819-141-10-200411160-00009 DO - 10.7326/0003-4819-141-10-200411160-00009 ID - Ioannidis2004 ER - TY - STD TI - Zorzela L, Loke YK, Ioannidis JP, Golder S, Santaguida P, Altman DG, Moher D, Vohra S. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ. 2016;352. ID - ref7 ER - TY - JOUR AU - Lineberry, N. AU - Berlin, J. A. AU - Mansi, B. AU - Glasser, S. AU - Berkwits, M. AU - Klem, C. AU - Bhattacharya, A. AU - Citrome, L. AU - Enck, R. AU - Fletcher, J. PY - 2016 DA - 2016// TI - Recommendations to improve adverse event reporting in clinical trial publications: A joint pharmaceutical industry/journal editor perspective JO - BMJ VL - 355 UR - https://doi.org/10.1136/bmj.i5078 DO - 10.1136/bmj.i5078 ID - Lineberry2016 ER - TY - JOUR AU - Crowe, B. J. AU - Xia, H. A. AU - Berlin, J. A. AU - Watson, D. J. AU - Shi, H. AU - Lin, S. L. AU - Kuebler, J. AU - Schriver, R. C. AU - Santanello, N. C. AU - Rochester, G. PY - 2009 DA - 2009// TI - Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team JO - Clin Trials VL - 6 UR - https://doi.org/10.1177/1740774509344101 DO - 10.1177/1740774509344101 ID - Crowe2009 ER - TY - STD TI - Communication from the Commission. Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’). Off J Eur Union. 2011; C 172/1. ID - ref10 ER - TY - STD TI - Food and Drug Administration. Guidance for Industry and Investigators. Safety Reporting Requirements for INDs and BA/BE studies: Edited by Administration USDoHaHSFaD, (CDER) CfDEaR, (CBER); CfBEaR; 2012. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-reporting-requirements-indsinvestigational-new-drug-applications-and-babe. UR - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-reporting-requirements-indsinvestigational-new-drug-applications-and-babe ID - ref11 ER - TY - STD TI - Food and Drug Administration. Safety assessment for IND safety reporting guidance for industry: Food and Drug Administration; 2015. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-assessment-ind-safety-reporting-guidance-industry. UR - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-assessment-ind-safety-reporting-guidance-industry ID - ref12 ER - TY - STD TI - Singh S, Loke YK. Drug safety assessment in clinical trials: methodological challenges and opportunities. 2012;13(138). https://doi.org/10.1186/1745-6215-13-138. ID - ref13 ER - TY - JOUR AU - Zink, R. C. AU - Marchenko, O. AU - Sanchez-Kam, M. AU - Ma, H. AU - Jiang, Q. PY - 2018 DA - 2018// TI - Sources of safety data and statistical strategies for design and analysis:clinical trials JO - Ther Innov Regul Sci VL - 52 UR - https://doi.org/10.1177/2168479017738980 DO - 10.1177/2168479017738980 ID - Zink2018 ER - TY - JOUR AU - Siddiqui, O. PY - 2009 DA - 2009// TI - Statistical methods to analyze adverse events data of randomized clinical trials JO - J Biopharm Stat VL - 19 UR - https://doi.org/10.1080/10543400903105463 DO - 10.1080/10543400903105463 ID - Siddiqui2009 ER - TY - JOUR AU - Ma, H. AU - Ke, C. AU - Jiang, Q. AU - Snapinn, S. PY - 2015 DA - 2015// TI - Statistical considerations on the evaluation of imbalances of adverse events in randomized clinical trials JO - Ther Innov Regul Sci VL - 49 UR - https://doi.org/10.1177/2168479015587363 DO - 10.1177/2168479015587363 ID - Ma2015 ER - TY - BOOK PY - 2010 DA - 2010// TI - Attachment B: Clinical Safety Review of an NDA or BLA of the Good Review Practice. Clinical Review Template (MAPP 6010.3 Rev. 1) PB - Food and Drug Administration CY - Silver Spring ID - ref17 ER - TY - JOUR AU - Unkel, S. AU - Amiri, M. AU - Benda, N. AU - Beyersmann, J. AU - Knoerzer, D. AU - Kupas, K. AU - Langer, F. AU - Leverkus, F. AU - Loos, A. AU - Ose, C. PY - 2019 DA - 2019// TI - On estimands and the analysis of adverse events in the presence of varying follow-up times within the benefit assessment of therapies JO - Pharm Stat VL - 18 UR - https://doi.org/10.1002/pst.1915 DO - 10.1002/pst.1915 ID - Unkel2019 ER - TY - JOUR AU - Favier, R. AU - Crépin, S. PY - 2018 DA - 2018// TI - The reporting of harms in publications on randomized controlled trials funded by the “Programme Hospitalier de Recherche Clinique,” a French academic funding scheme JO - Clin Trials VL - 0 ID - Favier2018 ER - TY - JOUR AU - Arksey, H. AU - O'Malley, L. PY - 2005 DA - 2005// TI - Scoping studies: towards a methodological framework JO - Int J Soc Res Methodol VL - 8 UR - https://doi.org/10.1080/1364557032000119616 DO - 10.1080/1364557032000119616 ID - Arksey2005 ER - TY - JOUR AU - O'Brien, P. C. AU - Fleming, T. R. PY - 1979 DA - 1979// TI - A multiple testing procedure for clinical trials JO - Biometrics VL - 35 UR - https://doi.org/10.2307/2530245 DO - 10.2307/2530245 ID - O'Brien1979 ER - TY - CHAP AU - DeMets, D. L. AU - Lan, G. ED - Thall, P. F. PY - 1995 DA - 1995// TI - The alpha spending function approach to interim data analyses BT - Recent Advances in Clinical Trial Design and Analysis PB - Springer US CY - Boston ID - DeMets1995 ER - TY - STD TI - Tricco AC, Lillie E, Zarin W, et al. Prisma extension for scoping reviews (prisma-scr): checklist and explanation. Ann Intern Med. 2018. ID - ref23 ER - TY - JOUR AU - Moher, D. AU - Liberati, A. AU - Tetzlaff, J. AU - Altman, D. G. PY - 2009 DA - 2009// TI - Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement JO - PLoS Med VL - 6 UR - https://doi.org/10.1371/journal.pmed.1000097 DO - 10.1371/journal.pmed.1000097 ID - Moher2009 ER - TY - JOUR AU - Amit, O. AU - Heiberger, R. M. AU - Lane, P. W. PY - 2008 DA - 2008// TI - Graphical approaches to the analysis of safety data from clinical trials JO - Pharm Stat VL - 7 UR - https://doi.org/10.1002/pst.254 DO - 10.1002/pst.254 ID - Amit2008 ER - TY - JOUR AU - Chuang-Stein, C. AU - Le, V. AU - Chen, W. PY - 2001 DA - 2001// TI - Recent advancements in the analysis and presentation of safety data JO - Drug Information Journal VL - 35 UR - https://doi.org/10.1177/009286150103500207 DO - 10.1177/009286150103500207 ID - Chuang-Stein2001 ER - TY - JOUR AU - Chuang-Stein, C. AU - Xia, H. A. PY - 2013 DA - 2013// TI - The practice of pre-marketing safety assessment in drug development JO - J Biopharm Stat VL - 23 UR - https://doi.org/10.1080/10543406.2013.736805 DO - 10.1080/10543406.2013.736805 ID - Chuang-Stein2013 ER - TY - JOUR AU - Karpefors, M. AU - Weatherall, J. PY - 2018 DA - 2018// TI - The tendril plot—a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials JO - J Am Med Inform Assoc VL - 25 UR - https://doi.org/10.1093/jamia/ocy016 DO - 10.1093/jamia/ocy016 ID - Karpefors2018 ER - TY - JOUR AU - Southworth, H. PY - 2008 DA - 2008// TI - Detecting outliers in multivariate laboratory data JO - J Biopharm Stat VL - 18 UR - https://doi.org/10.1080/10543400802369046 DO - 10.1080/10543400802369046 ID - Southworth2008 ER - TY - JOUR AU - Trost, D. C. AU - Freston, J. W. PY - 2008 DA - 2008// TI - Vector analysis to detect hepatotoxicity signals in drug development JO - Ther Innov Regul Science VL - 42 ID - Trost2008 ER - TY - JOUR AU - Zink, R. C. AU - Wolfinger, R. D. AU - Mann, G. PY - 2013 DA - 2013// TI - Summarizing the incidence of adverse events using volcano plots and time intervals JO - Clin Trials VL - 10 UR - https://doi.org/10.1177/1740774513485311 DO - 10.1177/1740774513485311 ID - Zink2013 ER - TY - JOUR AU - Bolland, K. AU - Whitehead, J. PY - 2000 DA - 2000// TI - Formal approaches to safety monitoring of clinical trials in life-threatening conditions JO - Stat Med VL - 19 UR - https://doi.org/3.0.CO;2-O DO - 3.0.CO;2-O ID - Bolland2000 ER - TY - JOUR AU - Fleishman, A. N. AU - Parker, R. A. PY - 2012 DA - 2012// TI - Stopping guidelines for harm in a study designed to establish the safety of a marketed drug JO - J Biopharm Stat VL - 22 UR - https://doi.org/10.1080/10543406.2010.536872 DO - 10.1080/10543406.2010.536872 ID - Fleishman2012 ER - TY - JOUR AU - Lieu, T. A. AU - Kulldorff, M. AU - Davis, R. L. AU - Lewis, E. M. AU - Weintraub, E. AU - Yih, K. AU - Yin, R. AU - Brown, J. S. AU - Platt, R. PY - 2007 DA - 2007// TI - Real-time vaccine safety surveillance for the early detection of adverse events JO - Med Care VL - 45 UR - https://doi.org/10.1097/MLR.0b013e3180616c0a DO - 10.1097/MLR.0b013e3180616c0a ID - Lieu2007 ER - TY - JOUR AU - Liu, J. P. PY - 2007 DA - 2007// TI - Rethinking statistical approaches to evaluating drug safety JO - Yonsei Med J VL - 48 UR - https://doi.org/10.3349/ymj.2007.48.6.895 DO - 10.3349/ymj.2007.48.6.895 ID - Liu2007 ER - TY - JOUR AU - Shih, M. C. AU - Lai, T. L. AU - Heyse, J. F. AU - Chen, J. PY - 2010 DA - 2010// TI - Sequential generalized likelihood ratio tests for vaccine safety evaluation JO - Stat Med VL - 29 UR - https://doi.org/10.1002/sim.4036 DO - 10.1002/sim.4036 ID - Shih2010 ER - TY - JOUR AU - Agresti AaK, B. PY - 2005 DA - 2005// TI - Multivariate tests comparing binomial probabilities, with application to safety studies for drugs JO - Appl Stat VL - 54 ID - Agresti AaK2005 ER - TY - JOUR AU - Bristol, D. R. AU - Patel, H. I. PY - 1990 DA - 1990// TI - A Markovian model for comparing incidences of side effects JO - Stat Med VL - 9 UR - https://doi.org/10.1002/sim.4780090709 DO - 10.1002/sim.4780090709 ID - Bristol1990 ER - TY - JOUR AU - Chuang-Stein, C. AU - Mohberg, N. R. AU - Musselman, D. M. PY - 1992 DA - 1992// TI - Organization and analysis of safety data using a multivariate approach JO - Stat Med VL - 11 UR - https://doi.org/10.1002/sim.4780110809 DO - 10.1002/sim.4780110809 ID - Chuang-Stein1992 ER - TY - JOUR AU - Huang, L. AU - Zalkikar, J. AU - Tiwari, R. PY - 2014 DA - 2014// TI - Likelihood ratio based tests for longitudinal drug safety data JO - Stat Med VL - 33 UR - https://doi.org/10.1002/sim.6103 DO - 10.1002/sim.6103 ID - Huang2014 ER - TY - JOUR AU - Mehrotra, D. V. AU - Adewale, A. J. PY - 2012 DA - 2012// TI - Flagging clinical adverse experiences: reducing false discoveries without materially compromising power for detecting true signals JO - Stat Med VL - 31 UR - https://doi.org/10.1002/sim.5310 DO - 10.1002/sim.5310 ID - Mehrotra2012 ER - TY - JOUR AU - Mehrotra, D. V. AU - Heyse, J. F. PY - 2004 DA - 2004// TI - Use of the false discovery rate for evaluating clinical safety data JO - Stat Methods Med Res VL - 13 UR - https://doi.org/10.1191/0962280204sm363ra DO - 10.1191/0962280204sm363ra ID - Mehrotra2004 ER - TY - JOUR AU - Allignol, A. AU - Beyersmann, J. AU - Schmoor, C. PY - 2016 DA - 2016// TI - Statistical issues in the analysis of adverse events in time-to-event data JO - Pharm Stat VL - 15 UR - https://doi.org/10.1002/pst.1739 DO - 10.1002/pst.1739 ID - Allignol2016 ER - TY - JOUR AU - Borkowf, C. B. PY - 2006 DA - 2006// TI - Constructing binomial confidence intervals with near nominal coverage by adding a single imaginary failure or success JO - Stat Med VL - 25 UR - https://doi.org/10.1002/sim.2469 DO - 10.1002/sim.2469 ID - Borkowf2006 ER - TY - STD TI - Evans SJW, Nitsch D. Statistics: Analysis and Presentation of Safety Data. In: Talbot J, Aronson JK, editors. Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice. 6th ed: Wiley; 2012. p. 349–88.. ID - ref45 ER - TY - JOUR AU - Gong, Q. AU - Tong, B. AU - Strasak, A. AU - Fang, L. PY - 2014 DA - 2014// TI - Analysis of safety data in clinical trials using a recurrent event approach JO - Pharm Stat VL - 13 UR - https://doi.org/10.1002/pst.1611 DO - 10.1002/pst.1611 ID - Gong2014 ER - TY - JOUR AU - Hengelbrock, J. AU - Gillhaus, J. AU - Kloss, S. AU - Leverkus, F. PY - 2016 DA - 2016// TI - Safety data from randomized controlled trials: applying models for recurrent events JO - Pharm Stat VL - 15 UR - https://doi.org/10.1002/pst.1757 DO - 10.1002/pst.1757 ID - Hengelbrock2016 ER - TY - JOUR AU - Lancar, R. AU - Kramar, A. AU - Haie-Meder, C. PY - 1995 DA - 1995// TI - Non-parametric methods for analysing recurrent complications of varying severity JO - Stat Med VL - 14 UR - https://doi.org/10.1002/sim.4780142409 DO - 10.1002/sim.4780142409 ID - Lancar1995 ER - TY - JOUR AU - Leon-Novelo, L. G. AU - Zhou, X. AU - Bekele, B. N. AU - Muller, P. PY - 2010 DA - 2010// TI - Assessing toxicities in a clinical trial: Bayesian inference for ordinal data nested within categories JO - Biometrics VL - 66 UR - https://doi.org/10.1111/j.1541-0420.2009.01359.x DO - 10.1111/j.1541-0420.2009.01359.x ID - Leon-Novelo2010 ER - TY - JOUR AU - Liu, G. F. AU - Wang, J. AU - Liu, K. AU - Snavely, D. B. PY - 2006 DA - 2006// TI - Confidence intervals for an exposure adjusted incidence rate difference with applications to clinical trials JO - Stat Med VL - 25 UR - https://doi.org/10.1002/sim.2335 DO - 10.1002/sim.2335 ID - Liu2006 ER - TY - JOUR AU - Nishikawa, M. AU - Tango, T. AU - Ogawa, M. PY - 2006 DA - 2006// TI - Non-parametric inference of adverse events under informative censoring JO - Stat Med VL - 25 UR - https://doi.org/10.1002/sim.2511 DO - 10.1002/sim.2511 ID - Nishikawa2006 ER - TY - JOUR AU - O'Gorman, T. W. AU - Woolson, R. F. AU - Jones, M. P. PY - 1994 DA - 1994// TI - A comparison of two methods of estimating a common risk difference in a stratified analysis of a multicenter clinical trial JO - Control Clin Trials VL - 15 UR - https://doi.org/10.1016/0197-2456(94)90017-5 DO - 10.1016/0197-2456(94)90017-5 ID - O'Gorman1994 ER - TY - JOUR AU - Rosenkranz, G. PY - 2006 DA - 2006// TI - Analysis of adverse events in the presence of discontinuations JO - Drug Inform J VL - 40 UR - https://doi.org/10.1177/009286150604000110 DO - 10.1177/009286150604000110 ID - Rosenkranz2006 ER - TY - JOUR AU - Sogliero-Gilbert, G. AU - Ting, N. AU - Zubkoff, L. PY - 1991 DA - 1991// TI - A statistical comparison of drug safety in controlled clinical trials: The Genie score as an objective measure of lab abnormalities JO - Ther Innov Regul Sci. VL - 25 ID - Sogliero-Gilbert1991 ER - TY - JOUR AU - Wang, J. AU - Quartey, G. PY - 2012 DA - 2012// TI - Nonparametric estimation for cumulative duration of adverse events JO - Biom J VL - 54 UR - https://doi.org/10.1002/bimj.201000256 DO - 10.1002/bimj.201000256 ID - Wang2012 ER - TY - JOUR AU - Wang, J. AU - Quartey, G. PY - 2013 DA - 2013// TI - A semi-parametric approach to analysis of event duration and prevalence JO - Comput Stat Data Anal VL - 67 UR - https://doi.org/10.1016/j.csda.2013.05.023 DO - 10.1016/j.csda.2013.05.023 ID - Wang2013 ER - TY - JOUR AU - Berry, D. A. PY - 1989 DA - 1989// TI - Monitoring accumulating data in a clinical trial JO - Biometrics VL - 45 UR - https://doi.org/10.2307/2531771 DO - 10.2307/2531771 ID - Berry1989 ER - TY - JOUR AU - French, J. L. AU - Thomas, N. AU - Wang, C. PY - 2012 DA - 2012// TI - Using historical data with Bayesian methods in early clinical trial monitoring JO - Stat Biopharm Res VL - 4 UR - https://doi.org/10.1080/19466315.2012.707088 DO - 10.1080/19466315.2012.707088 ID - French2012 ER - TY - JOUR AU - Yao, B. AU - Zhu, L. AU - Jiang, Q. AU - Xia, H. A. PY - 2013 DA - 2013// TI - Safety monitoring in clinical trials JO - Pharmaceutics VL - 5 UR - https://doi.org/10.3390/pharmaceutics5010094 DO - 10.3390/pharmaceutics5010094 ID - Yao2013 ER - TY - JOUR AU - Zhu, L. AU - Yao, B. AU - Xia, H. A. AU - Jiang, Q. PY - 2016 DA - 2016// TI - Statistical monitoring of safety in clinical trials JO - Stat Biopharm Res VL - 8 UR - https://doi.org/10.1080/19466315.2015.1117017 DO - 10.1080/19466315.2015.1117017 ID - Zhu2016 ER - TY - JOUR AU - Berry, S. M. AU - Berry, D. A. PY - 2004 DA - 2004// TI - Accounting for multiplicities in assessing drug safety: a three-level hierarchical mixture model JO - Biometrics VL - 60 UR - https://doi.org/10.1111/j.0006-341X.2004.00186.x DO - 10.1111/j.0006-341X.2004.00186.x ID - Berry2004 ER - TY - JOUR AU - Chen, W. AU - Zhao, N. AU - Qin, G. AU - Chen, J. PY - 2013 DA - 2013// TI - A bayesian group sequential approach to safety signal detection JO - J Biopharm Stat VL - 23 UR - https://doi.org/10.1080/10543406.2013.736813 DO - 10.1080/10543406.2013.736813 ID - Chen2013 ER - TY - JOUR AU - Gould, A. L. PY - 2008 DA - 2008// TI - Detecting potential safety issues in clinical trials by Bayesian screening JO - Biom J VL - 50 UR - https://doi.org/10.1002/bimj.200710469 DO - 10.1002/bimj.200710469 ID - Gould2008 ER - TY - JOUR AU - Gould, A. L. PY - 2013 DA - 2013// TI - Detecting potential safety issues in large clinical or observational trials by bayesian screening when event counts arise from poisson distributions JO - J Biopharm Stat VL - 23 UR - https://doi.org/10.1080/10543406.2013.789887 DO - 10.1080/10543406.2013.789887 ID - Gould2013 ER - TY - JOUR AU - McEvoy, B. W. AU - Nandy, R. R. AU - Tiwari, R. C. PY - 2013 DA - 2013// TI - Bayesian approach for clinical trial safety data using an Ising prior JO - Biometrics VL - 69 UR - https://doi.org/10.1111/biom.12051 DO - 10.1111/biom.12051 ID - McEvoy2013 ER - TY - JOUR AU - Xia, H. A. AU - Ma, H. AU - Carlin, B. P. PY - 2011 DA - 2011// TI - Bayesian hierarchical modeling for detecting safety signals in clinical trials JO - J Biopharm Stat VL - 21 UR - https://doi.org/10.1080/10543406.2010.520181 DO - 10.1080/10543406.2010.520181 ID - Xia2011 ER - TY - JOUR AU - Whone, A. AU - Luz, M. AU - Boca, M. AU - Woolley, M. AU - Mooney, L. AU - Dharia, S. AU - Broadfoot, J. AU - Cronin, D. AU - Schroers, C. AU - Barua, N. U. PY - 2019 DA - 2019// TI - Randomized trial of intermittent intraputamenal glial cell line-derived neurotrophic factor in Parkinson’s disease JO - Brain VL - 142 UR - https://doi.org/10.1093/brain/awz023 DO - 10.1093/brain/awz023 ID - Whone2019 ER - TY - JOUR AU - Wang, W. AU - Whalen, E. AU - Munsaka, M. AU - Li, J. AU - Fries, M. AU - Kracht, K. AU - Sanchez-Kam, M. AU - Singh, K. AU - Zhou, K. PY - 2018 DA - 2018// TI - On quantitative methods for clinical safety monitoring in drug development JO - Stat Biopharm Res VL - 10 UR - https://doi.org/10.1080/19466315.2017.1409134 DO - 10.1080/19466315.2017.1409134 ID - Wang2018 ER - TY - JOUR AU - Phillips, R. AU - Cornelius, V. PY - 2020 DA - 2020// TI - Understanding current practice, identifying barriers and exploring priorities for adverse event analysis in randomised controlled trials: an online, cross-sectional survey of statisticians from academia and industry JO - BMJ Open VL - 10 UR - https://doi.org/10.1136/bmjopen-2020-036875 DO - 10.1136/bmjopen-2020-036875 ID - Phillips2020 ER - TY - JOUR AU - Cornelius, V. R. AU - Sauzet, O. AU - Williams, J. E. AU - Ayis, S. AU - Farquhar-Smith, P. AU - Ross, J. R. AU - Branford, R. A. AU - Peacock, J. L. PY - 2013 DA - 2013// TI - Adverse event reporting in randomised controlled trials of neuropathic pain: considerations for future practice JO - PAIN VL - 154 UR - https://doi.org/10.1016/j.pain.2012.08.012 DO - 10.1016/j.pain.2012.08.012 ID - Cornelius2013 ER - TY - JOUR AU - Hum, S. W. AU - Golder, S. AU - Shaikh, N. PY - 2018 DA - 2018// TI - Inadequate harms reporting in randomized control trials of antibiotics for pediatric acute otitis media: a systematic review JO - Drug Saf. VL - 41 UR - https://doi.org/10.1007/s40264-018-0680-0 DO - 10.1007/s40264-018-0680-0 ID - Hum2018 ER - TY - JOUR AU - Patson, N. AU - Mukaka, M. AU - Otwombe, K. N. AU - Kazembe, L. AU - Mathanga, D. P. AU - Mwapasa, V. AU - Kabaghe, A. N. AU - Eijkemans, M. J. C. AU - Laufer, M. K. AU - Chirwa, T. PY - 2020 DA - 2020// TI - Systematic review of statistical methods for safety data in malaria chemoprevention in pregnancy trials JO - Malar J VL - 19 UR - https://doi.org/10.1186/s12936-020-03190-z DO - 10.1186/s12936-020-03190-z ID - Patson2020 ER - TY - STD TI - Food and Drug Administration. Guidance for industry e9 statistical principles for clinical trials: Food and Drug Administration. Food and Drug Administration; 1998. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e9-statistical-principlesclinical-trials. UR - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e9-statistical-principlesclinical-trials ID - ref73 ER - TY - STD TI - Harrell F. Continuous Learning from Data: No Multiplicities from Computing and Using Bayesian Posterior Probabilities as Often as Desired. In: Statistical Thinking, vol. 2019; 2018. https://www.fharrell.com/post/bayes-seq/. UR - https://www.fharrell.com/post/bayes-seq/ ID - ref74 ER - TY - STD TI - Spiegelhalter DJ, Abrams KR, Myles JP. An Overview of the Bayesian Approach. In: Bayesian Approaches to Clinical Trials and Health-Care Evaluation: John Wiley & Sons, Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK: Wiley; 2004. ID - ref75 ER - TY - JOUR AU - Gelman, A. AU - Hill, J. AU - Yajima, M. PY - 2012 DA - 2012// TI - Why We (Usually) Don't Have to Worry About Multiple Comparisons JO - J Res Educ Effect VL - 5 ID - Gelman2012 ER - TY - JOUR AU - Spiegelhalter, D. J. PY - 2004 DA - 2004// TI - Incorporating Bayesian ideas into health-care evaluation JO - Stat Sci VL - 19 UR - https://doi.org/10.1214/088342304000000080 DO - 10.1214/088342304000000080 ID - Spiegelhalter2004 ER - TY - JOUR AU - Ball, G. AU - Piller, L. B. PY - 2011 DA - 2011// TI - Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information part 2: statistical considerations JO - Contemp Clin Trials VL - 32 UR - https://doi.org/10.1016/j.cct.2011.05.009 DO - 10.1016/j.cct.2011.05.009 ID - Ball2011 ER - TY - JOUR AU - Gould, A. L. AU - Wang, W. B. PY - 2017 DA - 2017// TI - Monitoring potential adverse event rate differences using data from blinded trials: the canary in the coal mine JO - Stat Med VL - 36 UR - https://doi.org/10.1002/sim.7129 DO - 10.1002/sim.7129 ID - Gould2017 ER -