To blind or not to blind first in human and exploratory clinical trials: Acceleration of development vs. risk of bias-Reference-Cited by-同舟云学术

To blind or not to blind first in human and exploratory clinical trials: Acceleration of development vs. risk of bias

Published:2021-11-28 Issue: Volume: Page:
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clin Transl Sci

Author:

Haertter Sebastian¹,Kanodia Jitendar²,Cook Jack³,Alicea Jeanette⁴,Brennan Bonnie J.⁵,Desai Amit⁶,Patel Bela⁷,Pan Lin⁸,Goteti Kosalaram⁹

Affiliation:

1. Translational Medicine & Clinical Pharmacology Boehringer‐Ingelheim Pharma Ingelheim Germany

2. Clinical and Translational Pharmacology Theravance Biopharma US Inc. San Francisco California USA

3. Clinical Pharmacology Global Product Development Pfizer Inc. Groton Connecticut USA

4. Translational Medicine & Clinical Pharmacology Boehringer Ingelheim Pharmaceuticals, Inc Ridgefield Connecticut USA

5. Clinical Pharmacology SBU Oncology Bayer HealthCare Pharmaceuticals Whippany New Jersey USA

6. Clinical Pharmacology and Exploratory Development Astellas Pharma Global Development, Inc. Northbrook Illinois USA

7. Quantitative Pharmacology & Pharmacometrics (QP2) PPDM, Merck & Co., Inc. Kenilworth New Jersey USA

8. Clinical Pharmacology Genentech, Inc. South San Francisco California USA

9. Quantitative Pharmacology EMD Serono Research and Development Institute, Inc. (an affiliate of Merck KGaA, Darmstadt Germany) Billerica Massachusetts USA

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.13200

Reference19 articles.

1. The endless frontier? The recent increase of R&D productivity in pharmaceuticals

2. The cost of drug development: A systematic review

3. Optimizing Trial Design

4. Embracing model-based designs for dose-finding trials

5. Blinded and unblinded sample size reestimation in crossover trials balanced for period

Cited by 1 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Result reporting and early discontinuation of sepsis trials registered on ClinicalTrials.gov;Journal of Evidence-Based Medicine;2023-06