Clinical and prophylactic trials with assured new treatment for those at greater risk: II. Examples

M.O. Finkelstein, B. Levin and H. Robbins

American Journal of Public Health, 1996, vol. 86, issue 5, 696-702

Abstract: Objectives. The preceding article proposed an assured treatment design that would address certain diffculties in recruiting person who are at greater disk into randomized clinical trials. The purpose of this article is to illustrate the statistical validity of the design in a practical setting. Methods. Three actual randomized clinical trials were considered as case studies: in each, the data that would have been obtained under assured allocation were identified. Then, with only these data, together with a reasonable choice of model describing the response of subjects under standard treatment as a function of initial severity, the treatment effect was estimated for the subjects at greater risk. The estimates were compared with Conventional estimates for the sicker patients randomized in the original trials. Results. In each case, the estimates produced in the assured treatment trial were close to those observed in the randomized trial. Conclusions. Risk-based allocation trials deserve serious consideration when randomized clinical trials are difficult or impossible to rd The proposed designs and analyses would allow physicians to other persons at greater risk assurance that they would receive the new treatment, while researchers would retain the abaility to draw valid statistical conclusions about treatment efficacy.

Date: 1996
References: Add references at CitEc
Citations: View citations in EconPapers (5)

There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:aph:ajpbhl:1996:86:5:696-702_0

Access Statistics for this article

American Journal of Public Health is currently edited by Alfredo Morabia

More articles in American Journal of Public Health from American Public Health Association
Bibliographic data for series maintained by Christopher F Baum ().