An adaptive platform trial for evaluating treatments in patients with life‐threatening hemorrhage from traumatic injuries: Ethical and <scp>US</scp> regulatory considerations-Reference-Cited by-同舟云学术

An adaptive platform trial for evaluating treatments in patients with life‐threatening hemorrhage from traumatic injuries: Ethical and US regulatory considerations

Published:2022-06-24 Issue:S1 Volume:62 Page:
ISSN:0041-1132
Container-title:Transfusion
language:en
Short-container-title:Transfusion

Author:

Goldkind Sara F.¹,Brosch Laura R.²,Lewis Roger J.³⁴⁵,Pedroza Claudia⁶,Spinella Philip C.⁷^ORCID,Yadav Kabir³⁴^ORCID,Shackelford Stacy A.⁸^ORCID,Holcomb John B.⁹^ORCID

Affiliation:

1. Goldkind Consulting, LLC Chevy Chase Maryland USA

2. Uniformed Services University of the Health Sciences Bethesda Maryland USA

3. Department of Emergency Medicine Harbor‐UCLA Medical Center Torrance California USA

4. Department of Emergency Medicine David Geffen School of Medicine at UCLA Los Angeles California USA

5. Berry Consultants, LLC Austin Texas USA

6. Department of Pediatrics, McGovern Medical School at UT Health The University of Texas Health Science Center at Houston Houston Texas USA

7. Department of Surgery and Critical Care Medicine University of Pittsburgh Pittsburgh Pennsylvania USA

8. Joint Trauma System, Defense Health Agency Joint Base San Antonio Fort Sam Houston Fort Sam Houston Texas USA

9. Department of Surgery, Division of Acute Care Surgery, Center for Injury Science University of Alabama at Birmingham Birmingham Alabama USA

Publisher

Wiley

Subject

Hematology,Immunology,Immunology and Allergy

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/trf.16986

Reference59 articles.

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2. U.S. Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research.Adaptive design clinical trials for drugs and biologics guidance for industry. U.S. Food and Drug Administration.2020. [cited 2022 Jan 27]. Available from:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/adaptive-design-clinical-trials-drugs-and-biologics-guidance-industry

3. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): Designing Master Protocols for Evaluation of Candidate COVID-19 Therapeutics

4. Adaptive platform trials: definition, design, conduct and reporting considerations

5. The Platform Trial

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1. Transforming research to improve therapies for trauma in the twenty-first century;Critical Care;2024-02-13

2. An adaptive platform trial for evaluating treatments in patients with life‐threatening hemorrhage from traumatic injuries: Rationale and proposal;Transfusion;2022-06-22