Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation

Evaluating the Use of Nonrandomized Real World Data Analyses for Regulatory Decision Making

(2019) Jessica M. Franklin et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The US Food and Drug Administration's Real‐World Evidence Framework: A Commitment for Engagement and Transparency on Real‐World Evidence

(2019) M. Khair ElZarrad et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Commentary on the EMA R eflection P aper on the use of extrapolation in the development of medicines for paediatrics

(2019) Cécile Ollivier et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Real‐World Data, Advanced Analytics, and the Evolution of Postmarket Drug Safety Surveillance

(2019) Gerald J. Dal Pan   CLINICAL PHARMACOLOGY & THERAPEUTICS

Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe

(2019) Alison Cave et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Real‐World Evidence of Treatment Effects: The Useful and the Misleading

(2019) Sebastian Schneeweiss   CLINICAL PHARMACOLOGY & THERAPEUTICS

Small But Mighty: The Use of Real‐World Evidence to Inform Precision Medicine

(2019) Rebecca A. Miksad et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

What Does It Take to Transform Real-World Data Into Real-World Evidence?

(2019) Anuradha Ramamoorthy et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Data rich, information poor; can we use electronic health records to create a learning healthcare system for pharmaceuticals?

(2018) Hans-Georg Eichler et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Subgroup identification in clinical trials via the predicted individual treatment effect

(2018) Nicolás M. Ballarini et al.   PLoS One

Personalized evidence based medicine: predictive approaches to heterogeneous treatment effects

(2018) David M Kent et al.   BMJ-British Medical Journal

A review of methods for comparing treatments evaluated in studies that form disconnected networks of evidence

(2017) John W. Stevens et al.   Research Synthesis Methods

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

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

Identification of predicted individual treatment effects in randomized clinical trials

(2016) Andrea Lamont et al.   STATISTICAL METHODS IN MEDICAL RESEARCH

Reweighting Rct Evidence To Better Reflect Real Life: A Case Study of The Innovation Medicines Initiative

(2016) M Happich et al.   VALUE IN HEALTH

Sharing clinical trial data on patient level: Opportunities and challenges

(2014) Franz Koenig et al.   BIOMETRICAL JOURNAL

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

(2014) Heinz Schmidli et al.   BIOMETRICS

The risks of methodology aversion in drug regulation

(2014) Peter Bauer et al.   NATURE REVIEWS DRUG DISCOVERY

Assessing comparative effectiveness of new drugs before approval using prospective network meta-analyses

(2013) Huseyin Naci et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

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

(2013) Kert Viele et al.   PHARMACEUTICAL STATISTICS