The use of external controls: To what extent can it currently be recommended?

Current statistical considerations and regulatory perspectives on the planning of confirmatory basket, umbrella and platform trials

(2020) Olivier Collignon et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Are cancer patients better off if they participate in clinical trials? A mixed methods study

(2020) Zandra Engelbak Nielsen et al.   BMC CANCER

Generating Real-World Tumor Burden Endpoints from Electronic Health Record Data: Comparison of RECIST, Radiology-Anchored, and Clinician-Anchored Approaches for Abstracting Real-World Progression in Non-Small Cell Lung Cancer

(2019) Sandra D. Griffith et al.   ADVANCES IN THERAPY

Power gains by using external information in clinical trials are typically not possible when requiring strict type I error control

(2019) Annette Kopp‐Schneider et al.   BIOMETRICAL JOURNAL

A multistate model for early decision‐making in oncology

(2019) Ulrich Beyer et al.   BIOMETRICAL JOURNAL

Using Electronic Health Records to Derive Control Arms for Early Phase Single‐Arm Lung Cancer Trials: Proof‐of‐Concept in Randomized Controlled Trials

(2019) Gillis Carrigan et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

(2019) Hans‐Georg Eichler et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Trial designs using real‐world data: The changing landscape of the regulatory approval process

(2019) Elodie Baumfeld Andre et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

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

(2018) Jessica Lim et al.   Therapeutic Innovation & Regulatory Science

Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both

(2017) Janet Woodcock et al.   NEW ENGLAND JOURNAL OF MEDICINE

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

Controlling for Informed Presence Bias Due to the Number of Health Encounters in an Electronic Health Record

(2016) Benjamin A. Goldstein et al.   AMERICAN JOURNAL OF EPIDEMIOLOGY

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

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

Efficiencies of platform clinical trials: A vision of the future

(2016) Benjamin R Saville et al.   Clinical Trials

Increasing value and reducing waste in biomedical research: who's listening?

(2016) David Moher et al.   LANCET

Mediation analysis of the relationship between institutional research activity and patient survival

(2014) Justine Rochon et al.   BMC Medical Research Methodology

How to increase value and reduce waste when research priorities are set

(2014) Iain Chalmers et al.   LANCET

Knowledge translation of research findings

(2012) Jeremy M Grimshaw et al.   Implementation Science