Monitoring versus interim analysis of clinical trials: a perspective from the pharmaceutical industry.
Publication
, Journal Article
Enas, GG; Dornseif, BE; Sampson, CB; Rockhold, FW; Wuu, J
Published in: Control Clin Trials
March 1989
The definitions of "interim analysis" and "monitoring" of clinical trials are often ambiguous in the current literature. The resulting confusion can lead to erroneous conclusions and misguided decisions, especially when activities that are operational or observational are evaluated in a probabilistic sense as inferential. The authors seek to define "interim analysis" and "monitoring" in a mutually exclusive fashion. These definitions will then provide the opportunity to review and categorize existing clinical trial practices and procedures. This will clarify such issues as "when to look" and "when to pay a price" (e.g., test size and power) and characterize such issues in the context of pharmaceutical industry drug development.
Duke Scholars
Published In
Control Clin Trials
DOI
ISSN
0197-2456
Publication Date
March 1989
Volume
10
Issue
1
Start / End Page
57 / 70
Location
United States
Related Subject Headings
- Statistics as Topic
- Safety
- Research Design
- Public Health
- Patient Advocacy
- Humans
- General Clinical Medicine
- Drug Industry
- Double-Blind Method
- Clinical Trials as Topic
Citation
APA
Chicago
ICMJE
MLA
NLM
Enas, G. G., Dornseif, B. E., Sampson, C. B., Rockhold, F. W., & Wuu, J. (1989). Monitoring versus interim analysis of clinical trials: a perspective from the pharmaceutical industry. Control Clin Trials, 10(1), 57–70. https://doi.org/10.1016/0197-2456(89)90018-4
Enas, G. G., B. E. Dornseif, C. B. Sampson, F. W. Rockhold, and J. Wuu. “Monitoring versus interim analysis of clinical trials: a perspective from the pharmaceutical industry.” Control Clin Trials 10, no. 1 (March 1989): 57–70. https://doi.org/10.1016/0197-2456(89)90018-4.
Enas GG, Dornseif BE, Sampson CB, Rockhold FW, Wuu J. Monitoring versus interim analysis of clinical trials: a perspective from the pharmaceutical industry. Control Clin Trials. 1989 Mar;10(1):57–70.
Enas, G. G., et al. “Monitoring versus interim analysis of clinical trials: a perspective from the pharmaceutical industry.” Control Clin Trials, vol. 10, no. 1, Mar. 1989, pp. 57–70. Pubmed, doi:10.1016/0197-2456(89)90018-4.
Enas GG, Dornseif BE, Sampson CB, Rockhold FW, Wuu J. Monitoring versus interim analysis of clinical trials: a perspective from the pharmaceutical industry. Control Clin Trials. 1989 Mar;10(1):57–70.
Published In
Control Clin Trials
DOI
ISSN
0197-2456
Publication Date
March 1989
Volume
10
Issue
1
Start / End Page
57 / 70
Location
United States
Related Subject Headings
- Statistics as Topic
- Safety
- Research Design
- Public Health
- Patient Advocacy
- Humans
- General Clinical Medicine
- Drug Industry
- Double-Blind Method
- Clinical Trials as Topic