[1] Laughren T.Premarketing studies in the drug approval process:understanding their limitations regarding the assessment of drugsafety[J]. Clin Ther, 1998, 20(Suppl C): C12-C19. [2] Ma H, Ke C, Jiang Q, et al.Statistical Considerations on theEvaluation of Imbalances of Adverse Events in RandomizedClinical Trials[J]. Ther Innov Regul Sci, 2015, 49(6): 957-965. [3] U.S. Food and Drug Administration, U.S. Department of Health and Human Services. Guideline Document: Format and Content of the Clinical and Statistical Sections of an Application [EB/OL]. (2018-08-24) [2019-09-25]. https://www.fda.gov/media/71436/download. [4] ICH. Structure and content of clinical study reports (E3) [EB/OL].(1995-11-30) [2019-09-25]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf. [5] Ioannidis JP, Evans SJ, Gotzsche PC, et al.Better reporting of harms in randomized trials: an extension of the CONSORT statement[J]. Ann Intern Med, 2004, 141(10): 781-788. [6] Philips R, Hazell L, Sauzet O, et al.Analysis and reporting of adverse events in randomised controlled trials: a review[J]. BMJ Open, 2019, 9(2): e024537. [7] Tsang R, Colley L, Lynd LD.Inadequate statistical power to detect clinically significant differences in adverse event rates in randomized controlled trials[J]. J Clin Epidemiol, 2009, 62(6): 609-616. [8] ICH. MedDRA Introductory Guide Version 22.0 [EB/OL]. (2019-03) [2019-09-25]. https://www.meddra.org/sites/default/files/guidance/file/intguide_22_0_english.pdf. [9] U.S. Department of Health and Human Services, U.S. Food and Drug Administration. Premarketing Risk Assessment [EB/OL]. (2005-03-29) [2019-09-25]. https://www.fda.gov/media/71650/download. [10] Nautiyal N, Rastogi R, Gamperl HJ.Drug Safety Assessment in Clinical Trials: Concepts and Issues[J]. Int J Pharm Sci Res 2015, 6(10): 4159-4167. [11] ICH. The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions (E1) [EB/OL]. (1994-10-27) [2019-09-25]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E1/Step4/E1_Guideline.pdf. [12] ICH. Statistical Principles for Clinical Trials (E9) [EB/OL]. (1998-02-05) [2019-09-25]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf. [13] ICH. Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs): E2B(R3) Data Elements and Message Specification [EB/OL]. (2016-11-10) [2019-09-25]. http://estri.ich.org/e2br3/E2B(R3)_IG_Complete_Package_v1_07.zip. [14] Zink RC, Marchenko O, Sanchez-kam M, et al. Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials[J]. Ther Innov Regul Sci, 2018, 52(2): 141-158. [15] Kuchinke W, Wiegelmann S, Verplancke P, et al.Extended cooperation in clinical studies through exchange of CDISC metadata between different study software solutions[J]. Methods Inf Med, 2006, 45(4): 441-446. [16] Sawchik J, Hamdani J, Vanhaeverbeek M.Randomized clinical trials and observational studies in the assessment of drug safety[J].Rev Epidemiol Sante Publique, 2018, 66(3): 217-225. [17] Onell RT.Statistical analyses of adverse event data from clinical trials.Special emphasis on serious events[J]. Drug Inf J, 1987, 21(1): 9-20. [18] Siddiqui O.Statistical methods to analyze adverse events data of randomized clinical trials[J]. J Biopharm Stat, 2009, 19(5): 889-899. [19] Singh S, Loke YK.Drug safety assessment in clinical trials: methodological challenges and opportunities[J]. Trials, 2012, 13: 138. [20] Berry SM, Berry DA.Accounting for multiplicities in assessing drug safety: a three-level hierarchical mixture model[J].Biometrics, 2004, 60(2): 418-426. [21] Crowe BJ, Xia HA, Berlin JA, et al.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[J]. Clin Trials, 2009, 6(5): 430-440. [22] Le-radenmcher J, Hillman SL, Meyers J, et al. Statistical controversies in clinical research: Value of adverse events relatedness to study treatment: analyses of data from randomized double-blind placebo-controlled clinical trials[J]. Ann Oncol, 2017, 28(6): 1183-1190. [23] Oneill RT.Statistical concepts in the planning and evaluation of drug safety from clinical trials in drug development: issues of international harmonization[J]. Stat Med, 1995, 14(9-10): 117-127. [24] Luo J, Eldredge C, Cho CC, et al.Population Analysis of Adverse Events in Different Age Groups Using Big Clinical Trials Data[J]. JMIR Med Inform, 2016, 4(4): e30. [25] Jones M, Tett SE, Del Mar C.Psychiatric adverse events in oseltamivir prophylaxis trials: Novel comparative analysis using data obtained from clinical study reports[J]. Pharmacoepidemiol Drug Saf, 2018, 27(11): 1217-1222. |