Charles M. Beasley, Jr and Roy Tamura: What We Know and Do Not Know by Conventional Statistical Standards About Whether a Drug Does or Does Not Cause a Specific Side Effect (Adverse Drug Reaction)
Beasley CM, Dornseif B, Bosomworth J, Sayler ME, Rampey AH Jr, Heiligenstein JH, Thompson VL, Murphy DJ, Masica DN. Fluoxetine and suicide: a meta-analysis of controlled trials of treatment for depression. BMJ 1991; 303:685-92.
Beasley CM, Ball S, Nilsson M. Fluoxetine and adult suicidality revisited: an updated meta-analysis using expanded data sources from placebo-controlled trials. J Clin Psychopharmacol 2007; 27:682-86.
Beasley CM. Charles M. Beasley, Jr’s comment regarding Blackwell’s essay: Corporate Corruption in the Pharmaceutical Industry. inhn.org.contoversies. March 23, 2017.
Beasley CM. Charles M. Beasley, Jr’s response to Blackwell’s reply. Corporate Corruption in the Pharmaceutical Industry. inhn.org.controversies. January 12, 2018.
Blackwell B. Corporate Corruption in the Pharmaceutical Industry. inhn.org.controversies. September 1, 2016.
Blackwell B. Reply to Beasley’s comment. inhn.org.controversies. July 13, 2017.
Chen L, Bonson KR. An equivalence test for the comparison between a test drug and placebo in human abuse potential studies. J Biopharm Stat 2013; 23:294-306.
Eypasch E, Lefering R, Kum CK, Troidl H. Probability of adverse events that have not yet occurred: statistical reminder. BMJ 1995; 311:619-20.
Frey N, Jossi J, Bodmer M, Bircher A, Jick SS, Meier CR, Spoendlin J. The epidemiology of Stevens-Johnson syndrome and toxic epidermal necrolysis in the UK. J Invest Dermatol 2017; 137:1240-57.
Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA 1983; 249:1743-5.
Hirshberg B, Katz A. Cardiovascular outcome studies with novel antidiabetic agents: scientific and operational considerations. Diabetes Care 2013; 36(Supplement 2):S253-S8.
International Agranulocytosis and Aplastic Anemia Study. Incidence of aplastic anaemia: the relevance of diagnostic criteria. Blood 1987; 70:1718-21.
Jovanovic BD, Levy PS. A look at the rule of three. Am Stat 1997; 51:137-9.
Kaufman DW, Kelly JP, Issaragrisil S, Laporte JR, Anderson T, Levy M, Shapiro S, Young NS. Relative incidence of agranulocytosis and aplastic anemia. Am J Hematol 2006; 81:65-7.
Ludbrook J, Lew MJ. Estimating the risk of rare complications: is the ‘rule of three’ good enough? Anz J Surg 2009; 79:565-70.
Malik M. Problems of heart rate correction in assessment of drug-induced QT interval prolongation. J Cardiovasc Electrophysiol 2001; 12:411-20.
Mauri L, D’Agostino RB Sr. Challenges in the design and interpretation of noninferiority trials. NEJM 2017; 377:1357-67
NCSS 12 Statistical Software. 2018. NCSS, LLC.: Kaysville, UT. ncss.com/software/ncss.
Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and cardiovascular and renal events in type 2 diabetes. NEJM 2017; 377:644-57.
Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. NEJM 2007; 356:2457-71.
nQuery Advanced (126.96.36.199). Statsols: Cambridge, MA. statsols.com/nquery.
Packer M. Have we really demonstrated the cardiovascular safety of anti-hyperglycaemic drugs? Rethinking the concepts of macrovascular and microvascular disease in type 2 diabetes. Diabetes Obes Metab 2018; 20:1089-1095.
PASS 15 Power Analysis and Sample Size Software. 2017. NCSS, LLC.: Kaysville, UT. ncss.com/software/ncss.
Regier EE, Venkat MV, Close KL. More than 7 years hindsight: revisiting the FDA’s 2008 guidance on cardiovascular outcomes trials for type 2 diabetes medications. Clin Diabetes 2016; 34:173-80.
Smith RJ, Goldfine AB, Hiatt WR. Evaluating the cardiovascular safety of new medications for type 2 diabetes: time to reassess? Diabetes Care 2016; 39:738-42.
Tian L, Cai T, Pfeffer M, Piankov N, Cremieux P-Y, Wei LJ. Exact and efficient inference procedure for meta-analysis and its application to the analysis of independent 2 × 2 tables with all available data but without artificial continuity correction. Biostatistics 2009; 10:275–281.
UKPDS Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998a; 352:837-53.
UKPDS Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998b; 352:854-65.
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guideline for Industry: The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions. ICH-E1A. March 1995.
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. December 2008. www.fda.gov/downloads/Drugs/Guidances/ucm071627.pdf.
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Guideline for Industry: Premarketing Risk Assessment. March 2005. www.fda.gov/downloads/ regulatoryinformation/guidances/ucm126958.pdf.
Yang F, Stewart M, Ye J, DeMets D. Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements. Diabetes Metab Syndr Obes 2015; 8:315-25.
Yang M-S, Lee JY, Kim J, Gun-Woo Kim, Byung-Keun Kim, Ju-Young Kim, Heung-Woo Park, Sang-Heon Cho, Kyung-Up Min, Hye-Ryun Kang. Incidence of Stevens-Johnson syndrome and toxic epidermal necrolysis: a nationwide population-based study using national health insurance database in Korea. PloS ONE 2016.
Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. NEJM 2015; 373:2117-28.
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