“Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?-Reference-Cited by-同舟云学术

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

Published:2016-10-19 Issue:6 Volume:100 Page:699-712
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Eichler H‐G¹,Bloechl‐Daum B²,Bauer P³,Bretz F⁴,Brown J⁵,Hampson LV⁶,Honig P⁷,Krams M⁸,Leufkens H⁹,Lim R¹⁰,Lumpkin MM¹¹,Murphy MJ¹²,Pignatti F¹,Posch M³,Schneeweiss S¹³,Trusheim M¹⁴,Koenig F³

Affiliation:

1. European Medicines AgencyLondon United Kingdom

2. Department of Clinical PharmacologyMedical University of ViennaVienna Austria

3. Section for Medical Statistics, Center for Medical Statistics, Informatics, and Intelligent SystemsMedical University of ViennaVienna Austria

4. NovartisBasel Switzerland

5. Harvard Medical School/Harvard Pilgrim Health Care InstituteHartford Connecticut USA

6. Lancaster UniversityLancaster United Kingdom

7. Collegeville Pennsylvania USA

8. Janssen Pharmaceutical CompaniesRaritan New Jersey USA

9. Medicines Evaluation Board, UtrechtUniversity of UtrechtUtrecht The Netherlands

10. Health CanadaOttawa Ontario Canada

11. Bill and Melinda Gates FoundationSeattle Washington USA

12. Project Data SphereDurham North Carolina USA

13. Brigham and Women's Hospital and Harvard Medical SchoolBoston Massachusetts USA

14. MIT Sloan School of ManagementCambridge Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.515

Reference70 articles.

1. International Council on Harmonization.ICH Topic E10: Choice of control groups in clinical trials. .

2. The combination of randomized and historical controls in clinical trials

3. Bridging the efficacy–effectiveness gap: a regulator's perspective on addressing variability of drug response

4. Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials

5. Bias modelling in evidence synthesis

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