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Participation of Community Hospitals in Clinical Trials

Authors :
Colin B. Begg
Marvin Zelen
Paul Elson
Paul P. Carbone
Source :
New England Journal of Medicine. 306:1076-1080
Publication Year :
1982
Publisher :
Massachusetts Medical Society, 1982.

Abstract

The Eastern Cooperative Oncology Group (ECOG) initiated a program in 1976 to involve community hospitals in multi-institutional clinical trials. The community hospitals can be characterized as generally having no tradition of participating in clinical trials of cancer therapy, whereas the ECOG member institutions are university hospitals or major treatment centers. More than 100 community hospitals participated in 97 randomized trials involving 4506 patients from November 1976 through February 1981. Comparisons between the community hospitals and the ECOG member institutions indicate that the quality of participation was similar, as measured by rates of ineligibility, compliance with the protocol, and submission of data. Objective measures of outcome, such as survival, response, and toxicity, were also comparable. We conclude that under the mechanism adopted by the ECOG, it is possible to include community hospitals in clinical trials of cancer therapy without reducing the quality of the data or compromising the therapeutic outcomes.

Details

ISSN :
15334406 and 00284793
Volume :
306
Database :
OpenAIRE
Journal :
New England Journal of Medicine
Accession number :
edsair.doi.dedup.....ab046352b81006b64aebfbca166bbfe0