Adaptive design in clinical research: issues, opportunities, and recommendations.
Publication
, Journal Article
Chang, M; Chow, S-C; Pong, A
Published in: J Biopharm Stat
May 2006
The issues and opportunities of adaptive designs are discussed. Starting with the definitions of an adaptive design, its validity and integrity are discussed. The three key components of an adaptive design, i.e., Type I error control, p-value adjustment, and unbiased estimation and confidence interval are addressed. Various seamless designs are investigated. Recommendations are made in the following aspects: study planning, trial monitoring, analysis and reporting, trial simulation, and regulatory perspectives.
Duke Scholars
Published In
J Biopharm Stat
DOI
ISSN
1054-3406
Publication Date
May 2006
Volume
16
Issue
3
Start / End Page
299 / 309
Location
England
Related Subject Headings
- Statistics & Probability
- Sample Size
- Research Design
- Humans
- Guidelines as Topic
- Data Interpretation, Statistical
- Clinical Trials as Topic
- Bayes Theorem
- 4905 Statistics
- 3214 Pharmacology and pharmaceutical sciences
Citation
APA
Chicago
ICMJE
MLA
NLM
Chang, M., Chow, S.-C., & Pong, A. (2006). Adaptive design in clinical research: issues, opportunities, and recommendations. J Biopharm Stat, 16(3), 299–309. https://doi.org/10.1080/10543400600609718
Chang, Mark, Shein-Chung Chow, and Annpey Pong. “Adaptive design in clinical research: issues, opportunities, and recommendations.” J Biopharm Stat 16, no. 3 (May 2006): 299–309. https://doi.org/10.1080/10543400600609718.
Chang M, Chow S-C, Pong A. Adaptive design in clinical research: issues, opportunities, and recommendations. J Biopharm Stat. 2006 May;16(3):299–309.
Chang, Mark, et al. “Adaptive design in clinical research: issues, opportunities, and recommendations.” J Biopharm Stat, vol. 16, no. 3, May 2006, pp. 299–309. Pubmed, doi:10.1080/10543400600609718.
Chang M, Chow S-C, Pong A. Adaptive design in clinical research: issues, opportunities, and recommendations. J Biopharm Stat. 2006 May;16(3):299–309.
Published In
J Biopharm Stat
DOI
ISSN
1054-3406
Publication Date
May 2006
Volume
16
Issue
3
Start / End Page
299 / 309
Location
England
Related Subject Headings
- Statistics & Probability
- Sample Size
- Research Design
- Humans
- Guidelines as Topic
- Data Interpretation, Statistical
- Clinical Trials as Topic
- Bayes Theorem
- 4905 Statistics
- 3214 Pharmacology and pharmaceutical sciences