Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage.
Publication
, Journal Article
Isaacs, J; Tan, AC; Hanks, BA; Wang, X; Owzar, K; Herndon, JE; Antonia, SJ; Piantadosi, S; Khasraw, M
Published in: Clin Cancer Res
January 1, 2022
Clinical trials that have a pharmacokinetic or a pharmacodynamic immunologic mechanism of action-based primary outcome could substantially improve the validity and efficiency of early development of immuno-oncology agents. Here, we outline different trial design options in this area, review examples from the literature and their unique immunologic aspects, and highlight how these trials have been underutilized. We illustrate how new technologies and translationally focused approaches can be successfully used to develop different classes of immunotherapeutic agents.
Duke Scholars
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Published In
Clin Cancer Res
DOI
EISSN
1557-3265
Publication Date
January 1, 2022
Volume
28
Issue
1
Start / End Page
13 / 22
Location
United States
Related Subject Headings
- Oncology & Carcinogenesis
- Neoplasms
- Medical Oncology
- Immunotherapy
- Immunologic Factors
- Humans
- Clinical Trials as Topic
- 3211 Oncology and carcinogenesis
- 3202 Clinical sciences
- 1112 Oncology and Carcinogenesis
Citation
APA
Chicago
ICMJE
MLA
NLM
Isaacs, J., Tan, A. C., Hanks, B. A., Wang, X., Owzar, K., Herndon, J. E., … Khasraw, M. (2022). Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage. Clin Cancer Res, 28(1), 13–22. https://doi.org/10.1158/1078-0432.CCR-21-1593
Isaacs, James, Aaron C. Tan, Brent A. Hanks, Xiaofei Wang, Kouros Owzar, James E. Herndon, Scott J. Antonia, Steven Piantadosi, and Mustafa Khasraw. “Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage.” Clin Cancer Res 28, no. 1 (January 1, 2022): 13–22. https://doi.org/10.1158/1078-0432.CCR-21-1593.
Isaacs J, Tan AC, Hanks BA, Wang X, Owzar K, Herndon JE, et al. Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage. Clin Cancer Res. 2022 Jan 1;28(1):13–22.
Isaacs, James, et al. “Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage.” Clin Cancer Res, vol. 28, no. 1, Jan. 2022, pp. 13–22. Pubmed, doi:10.1158/1078-0432.CCR-21-1593.
Isaacs J, Tan AC, Hanks BA, Wang X, Owzar K, Herndon JE, Antonia SJ, Piantadosi S, Khasraw M. Clinical Trials with Biologic Primary Endpoints in Immuno-oncology: Concepts and Usage. Clin Cancer Res. 2022 Jan 1;28(1):13–22.
Published In
Clin Cancer Res
DOI
EISSN
1557-3265
Publication Date
January 1, 2022
Volume
28
Issue
1
Start / End Page
13 / 22
Location
United States
Related Subject Headings
- Oncology & Carcinogenesis
- Neoplasms
- Medical Oncology
- Immunotherapy
- Immunologic Factors
- Humans
- Clinical Trials as Topic
- 3211 Oncology and carcinogenesis
- 3202 Clinical sciences
- 1112 Oncology and Carcinogenesis