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Summarizing historical information on controls in clinical trials

Summarizing historical information on controls in clinical trials

http://www.wikidata.org/entity/Q29397593

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Systematic reviews in paediatric multiple sclerosis and Creutzfeldt-Jakob disease exemplify shortcomings in methods used to evaluate therapies in rare conditions "Threshold-crossing": A Useful Way to Establish the Counterfactual in Clinical Trials?Fine mapping of type 1 diabetes susceptibility loci and evidence for colocalization of causal variants with lymphoid gene enhancers.Design and Measurement of Nonislet-Specific Autoantibodies for the Type 1 Diabetes Genetics Consortium Autoantibody Workshop HLA genotyping in the international Type 1 Diabetes Genetics Consortium Using historical control information for the design and analysis of clinical trials with overdispersed count data.Use of historical control data for assessing treatment effects in clinical trials.Increasing efficiency for estimating treatment-biomarker interactions with historical data.Better prediction by use of co-data: adaptive group-regularized ridge regression.Addressing potential prior-data conflict when using informative priors in proof-of-concept studies.Proceedings of the Tenth Annual UT-ORNL-KBRIN Bioinformatics Summit 2011.Extrapolation of efficacy and other data to support the development of new medicines for children: A systematic review of methods.Commensurate Priors for Incorporating Historical Information in Clinical Trials Using General and Generalized Linear Models.Quality control of phenotypic forms data in the Type 1 Diabetes Genetics Consortium.The inclusion of historical control data may reduce the power of a confirmatory study.Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial.HLA-check: evaluating HLA data from SNP information.Collection and processing of whole blood for transformation of peripheral blood mononuclear cells and extraction of DNA: the Type 1 Diabetes Genetics Consortium.Imputation of missing variance data using non-linear mixed effects modelling to enable an inverse variance weighted meta-analysis of summary-level longitudinal data: a case study.Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: unexpected results of a randomised, double-blind placebo-controlled trial.Addressing prior-data conflict with empirical meta-analytic-predictive priors in clinical studies with historical information.Supplementation of a clinical trial by historical control data: is the prospect of dynamic borrowing an illusion?Including historical data in the analysis of clinical trials: Is it worth the effort?Using phase II data for the analysis of phase III studies: An application in rare diseases.Advancing clinical trial design in pulmonary hypertension Creation and implementation of a historical controls database from randomized clinical trials.The current state of Bayesian methods in medical product development: survey results and recommendations from the DIA Bayesian Scientific Working Group.Bayesian methods for the design and analysis of noninferiority trials.Idle thoughts of a 'well-calibrated' Bayesian in clinical drug development.Equal access to innovative therapies and precision cancer care.Sample size determination for a binary response in a superiority clinical trial using a hybrid classical and Bayesian procedure.Bayesian survival analysis in clinical trials: What methods are used in practice?Designing and analysing clinical trials in mental health: an evidence synthesis approach.Using conditional power of network meta-analysis (NMA) to inform the design of future clinical trials.Detecting and accounting for violations of the constancy assumption in non-inferiority clinical trials.Using Bayesian analysis in repeated preclinical in vivo studies for a more effective use of animals.Bayesian bivariate meta-analysis of correlated effects: Impact of the prior distributions on the between-study correlation, borrowing of strength, and joint inferences.Selection of the effect size for sample size determination for a continuous response in a superiority clinical trial using a hybrid classical and Bayesian procedure.Reducing sample size in experiments with animals: historical controls and related strategies.Meta-analysis of two studies in the presence of heterogeneity with applications in rare diseases.

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P2860

Summarizing historical information on controls in clinical trials

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Clinical Trials

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Beat Neuenschwander

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David J Spiegelhalter

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Gorana Capkun-Niggli

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Michael Branson

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Genome-wide association study of 14,000 cases of seven common diseases and 3,000 shared controls

Genome-wide association study and meta-analysis find that over 40 loci affect risk of type 1 diabetes

Meta-analysis in clinical trials

Infliximab for induction and maintenance therapy for ulcerative colitis

HLA genotyping in the international Type 1 Diabetes Genetics Consortium

Genome-wide scan for linkage to type 1 diabetes in 2,496 multiplex families from the Type 1 Diabetes Genetics Consortium

Overview of the MHC fine mapping data.

Crossing international boundaries: implications for the Term Breech Trial Data Coordinating Centre.

Study conduct, monitoring and data management in a trinational trial: the OPTIMA model.

On the use of historical control data to estimate dose response trends in quantal bioassay.

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