Meta-analysis of clinical trial safety data in a drug development program: Answers to frequently asked questions

scientific article published on November 21, 2012

Meta-analysis of clinical trial safety data in a drug development program: Answers to frequently asked questions is …
instance of (P31):
meta-analysisQ815382
scholarly articleQ13442814

External links are
P356DOI10.1177/1740774512465495
P953full work available at URLhttps://journals.sagepub.com/doi/full-xml/10.1177/1740774512465495
https://journals.sagepub.com/doi/pdf/10.1177/1740774512465495
P698PubMed publication ID23171499

P2093author name stringEdward Whalen
Jesse A. Berlin
Juergen Kuebler
H. Amy Xia
Carol E. Koro
Brenda J. Crowe
P2860cites workEffect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular CausesQ22250883
Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysisQ24601392
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Individual patient- versus group-level data meta-regressions for the investigation of treatment effect modifiers: ecological bias rears its ugly headQ30670986
What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse dataQ30926358
The effect of antilymphocyte induction therapy on renal allograft survival. A meta-analysis of individual patient-level data. Anti-Lymphocyte Antibody Induction Therapy Study GroupQ32062983
Comparison of Meta-Analysis Versus Analysis of Variance of Individual Patient DataQ32067832
Use of the false discovery rate for evaluating clinical safety dataQ33203769
Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting teamQ33511715
Heterogeneity and statistical significance in meta-analysis: an empirical study of 125 meta-analysesQ33947262
Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trialsQ34619977
Why sources of heterogeneity in meta-analysis should be investigatedQ36888653
Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressantsQ37246423
Secondary use of randomized controlled trials to evaluate drug safety: a review of methodological considerationsQ37924038
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Bayesian Meta‐Experimental Design: Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 DiabetesQ41867314
Bayesian Hierarchical Modeling for Detecting Safety Signals in Clinical TrialsQ46097450
Suicidality in pediatric patients treated with antidepressant drugsQ46977975
Validity of indirect comparisons in meta-analysis.Q51924377
Indirect comparisons: the mesh and mess of clinical trialsQ51929967
Meta-regression detected associations between heterogeneous treatment effects and study-level, but not patient-level, factorsQ51990048
Random-effects meta-analyses are not always conservativeQ52915135
Relative risks and confidence intervals were easily computed indirectly from multivariable logistic regressionQ53025930
Bayesian measures of model complexity and fitQ56532420
CorrectionQ61875124
A comparison of statistical methods for combining event rates from clinical trialsQ69583295
Accounting for multiplicities in assessing drug safety: a three-level hierarchical mixture modelQ80166441
Applying the law of iterated logarithm to control type I error in cumulative meta-analysis of binary outcomesQ81234350
Academic perspectives on the United States Food and Drug Administration's guidance for industry on diabetes mellitusQ84521526
P433issue1
P407language of work or nameEnglishQ1860
P921main subjectclinical trialQ30612
meta-analysisQ815382
P304page(s)20-31
P577publication date2012-11-21
P1433published inClinical TrialsQ5133802
P1476titleMeta-analysis of clinical trial safety data in a drug development program: answers to frequently asked questions
Meta-analysis of clinical trial safety data in a drug development program: Answers to frequently asked questions
P478volume10

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cites work (P2860)
Q39036481A Bayesian meta-analytic approach for safety signal detection in randomized clinical trials
Q30885611Adaptive and repeated cumulative meta-analyses of safety data during a new drug development process
Q38950328An appraisal of meta-analysis guidelines: how do they relate to safety outcomes?
Q41424491Drug safety meta-analysis: promises and pitfalls.
Q46450711Guidance on the implementation and reporting of a drug safety Bayesian network meta-analysis
Q39973211Meta-analysis framework for exact inferences with application to the analysis of rare events
Q35857159Multivariate Meta-Analysis of Heterogeneous Studies Using Only Summary Statistics: Efficiency and Robustness
Q93243347On estimands and the analysis of adverse events in the presence of varying follow-up times within the benefit assessment of therapies
Q35860102Systematic Review and Meta-Analysis To Estimate Antibacterial Treatment Effect in Acute Bacterial Skin and Skin Structure Infection.
Q38480274Systematic review and meta-analysis of phase I/II targeted therapy combined with radiotherapy in patients with glioblastoma multiforme: quality of report, toxicity, and survival
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Q24288962Thresholds for statistical and clinical significance in systematic reviews with meta-analytic methods
Q24185986Viewpoint: taking into account risks of random errors when analysing multiple outcomes in systematic reviews

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