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Trials
Published in: Trials 1/2014

Open Access 01-12-2014 | Commentary

Commentary on ‘accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimized multi-arm phase I/II trial design’

Author: Dennis Dixon

Published in: Trials | Issue 1/2014

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Excerpt

The well-written manuscript has lead me to reflect on the present state of the art of designing early trials, not necessarily limited to trials of investigational vaccines. Standard trial designs are inadequate for this trial, as the authors demonstrate by their careful literature search and review. In fact, more and more research plans seem to need one or another departure from standard designs. Maybe the traditional pdigm of choosing a design that: (a) has been ‘credentialed’ by publication in a peer-reviewed methodology journal; and (b) is as close as possible to matching the actual research objectives of the investigators, even if not a precise match, is obsolete. …
Literature
1.
Gehan EA: The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. J Chronic Dis. 1961, 13: 346-353. 10.1016/0021-9681(61)90060-1.CrossRefPubMed
2.
Simon R: Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989, 10: 1-10. 10.1016/0197-2456(89)90015-9.CrossRefPubMed
3.
Thall PF, Cheng SC: Optimal two-stage designs for clinical trials based on safety and efficacy. Stat Med. 2001, 20: 1023-1032. 10.1002/sim.717.CrossRefPubMed
Metadata
Title
Commentary on ‘accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimized multi-arm phase I/II trial design’
Author
Dennis Dixon
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-76

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