Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials

An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems

(2017) Rolf Wachter et al.   Journal of the American Society of Hypertension

Use of a historical control group in a noninferiority trial assessing a new antibacterial treatment: A case study and discussion of practical implementation aspects

(2017) David Dejardin et al.   PHARMACEUTICAL STATISTICS

Adaptive power priors with empirical Bayes for clinical trials

(2017) Isaac Gravestock et al.   PHARMACEUTICAL STATISTICS

Including historical data in the analysis of clinical trials: Is it worth the effort?

(2017) Joost van Rosmalen et al.   STATISTICAL METHODS IN MEDICAL RESEARCH

Meta-analysis of two studies in the presence of heterogeneity with applications in rare diseases

(2016) Tim Friede et al.   BIOMETRICAL JOURNAL

“Threshold-crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?

(2016) H-G Eichler et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia

(2016) N. Gokbuget et al.   HAEMATOLOGICA

Proposed best practice for projects that involve modelling and simulation

(2016) Michael O'Kelly et al.   PHARMACEUTICAL STATISTICS

Idle thoughts of a ‘well-calibrated’ Bayesian in clinical drug development

(2016) Andrew P. Grieve   PHARMACEUTICAL STATISTICS

Extrapolation of efficacy and other data to support the development of new medicines for children: A systematic review of methods

(2016) Ian Wadsworth et al.   STATISTICAL METHODS IN MEDICAL RESEARCH

Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia

(2016) N Gökbuget et al.   Blood Cancer Journal

International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia

(2016) N. Gokbuget et al.   HAEMATOLOGICA

Sample size considerations for historical control studies with survival outcomes

(2015) Hong Zhu et al.   Journal of Biopharmaceutical Statistics

Predictive distributions were developed for the extent of heterogeneity in meta-analyses of continuous outcome data

(2015) Kirsty M. Rhodes et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

How to test hypotheses if you must

(2015) Andrew P. Grieve   PHARMACEUTICAL STATISTICS

Sample size calculation based on efficient unconditional tests for clinical trials with historical controls

(2015) Guogen Shan et al.   Journal of Biopharmaceutical Statistics

Robust meta-analytic-predictive priors in clinical trials with historical control information

(2014) Heinz Schmidli et al.   BIOMETRICS

Obstacles And Opportunities In Alzheimer’s Clinical Trial Recruitment

(2014) Jennifer L. Watson et al.   HEALTH AFFAIRS

Adaptive adjustment of the randomization ratio using historical control data

(2013) Brian P Hobbs et al.   Clinical Trials

Regulatory Issues of Propensity Score Methodology Application to Drug and Device Safety Studies

(2013) Mark S. Levenson et al.   Journal of Biopharmaceutical Statistics

Use of historical control data for assessing treatment effects in clinical trials

(2013) Kert Viele et al.   PHARMACEUTICAL STATISTICS

The current state of Bayesian methods in medical product development: survey results and recommendations from the DIA Bayesian Scientific Working Group

(2013) Fanni Natanegara et al.   PHARMACEUTICAL STATISTICS

Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development

(2012) Brenda Gaydos et al.   DRUG INFORMATION JOURNAL

Predicting the extent of heterogeneity in meta-analysis, using empirical data from the Cochrane Database of Systematic Reviews

(2012) Rebecca M Turner et al.   INTERNATIONAL JOURNAL OF EPIDEMIOLOGY

Regulatory Considerations in the Design of Comparative Observational Studies Using Propensity Scores

(2012) Lilly Q. Yue   Journal of Biopharmaceutical Statistics

Bayesian clinical trials in action

(2012) J. Jack Lee et al.   STATISTICS IN MEDICINE

An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies

(2011) Peter C. Austin   MULTIVARIATE BEHAVIORAL RESEARCH

Calculating sample size in trials using historical controls

(2010) Song Zhang et al.   Clinical Trials

Summarizing historical information on controls in clinical trials

(2010) Beat Neuenschwander et al.   Clinical Trials

Type I error rate control in adaptive designs for confirmatory clinical trials with treatment selection at interim

(2010) Martin Posch et al.   PHARMACEUTICAL STATISTICS

Optimal caliper widths for propensity-score matching when estimating differences in means and differences in proportions in observational studies

(2010) Peter C. Austin   PHARMACEUTICAL STATISTICS

Importance of protocols for simulation studies in clinical drug development

(2010) Mike K Smith et al.   STATISTICAL METHODS IN MEDICAL RESEARCH

The Relative Ability of Different Propensity Score Methods to Balance Measured Covariates Between Treated and Untreated Subjects in Observational Studies

(2009) Peter C. Austin   MEDICAL DECISION MAKING

Diagnosis, symptoms, frequency and mortality of 260 patients with urea cycle disorders from a 21-year, multicentre study of acute hyperammonaemic episodes

(2008) Marshall L Summar et al.   ACTA PAEDIATRICA