@article{fba933cac62a48d4bb9e6780166152bb,
title = "Unpublished data summaries and the design and conduct of clinical trials. The nutrition adjuvant study experience and commentary",
abstract = "A trend in cancer clinical investigation has been the application of new analytic techniques and reporting forums to summarize developing trial results. Examples include: Consensus Conference, Meta-Analyses, and most recently (in the breast cancer area), the {"}Clinical Alert.{"} These Unpublished Data Summaries have been widely disseminated in lay and scientific communities and have frequently engendered debate conducted in the absence of primary information. We now report the impact of this process on a national, cooperative group effort (the Nutrition Adjuvant Study [NAS]) designed to test a novel hypothesis involving dietary fat reduction as potential adjuvant breast cancer treatment. It is clear that these Unpublished Data Summaries in the breast cancer area directly resulted in changes in the NAS protocol design and may have influenced patient accrual. The challenge for clinical investigators and governmental agencies is to integrate the positive aspects of the new information forums with those of traditional {"}peer-review{"} publication into a system where the conduct of clinical investigation in a timely manner can be facilitated.",
keywords = "Adjuvant breast cancer, clinical alert, consensus conference, dietary fat, meta-analysis, nutrition and cancer",
author = "Chlebowski, {Rowan T.} and Blackburn, {George L.} and Nixon, {Daniel W.} and Peter Jochimsen and Scanlon, {Edward F.} and William Insull and {Marilyn Buzzard}, I. and Wynder, {Ernst L.} and Robert Elashoff",
note = "Funding Information: Following termination of NAS funding, eight of the ten participating centers submitted to the NCI an investigator-initiated research grant (RO-1) proposal to address the same question. This application, supported by the preliminary information obtained from the original NAS \[17,24\]w as successfully peer-reviewed in April of 1988. The study, essentially the same as the NAS, was renamed the Women's Intervention Nutrition Study (WINS) and involved dietary fat reduction as addition to tamoxifen for patients with resected lymph node-positive breast cancer. Prior to the actual awarding of funding and initiation of the WINS study, a {"}Clinical Alert{"} from the National Cancer Institute was sent to more than 13,000 practicing physicians in the United States \[2\]T. his communication summarized unpublished clinical trial results for patients with node-negative breast cancer stating, {"}the potential impact of the findings is so great{"} to inform practicing physicians {"}in advance of publication.{"} The Clinical Alert summarized data from three NCl-supported trials (NSABP B-I 3, NSABP B-14, and INT-0011) and suggested benefit for systemic adjuvant therapy with tamoxifen and/or cytotoxic chemotherapy in terms of relapse-free interval for patients with node-negative breast cancer. The Clinical Alert concluded that {"}outside of a trial setting, the treatments described represent credible therapeutic options worthy of careful attention.{"} A follow-up to the original Clinical Alert was necessary, correcting an error in dosage for one of the chemotherapy regimens described. Funding Information: The study outlined in this report {"}~,,as supported by the Public Service Co-operative Agreement UO1 CA37640 from the National Cancer Institute, National Institutes of t tealth, Bethesda, Mary,-land. Copyright: Copyright 2018 Elsevier B.V., All rights reserved.",
year = "1989",
month = dec,
doi = "10.1016/0197-2456(89)90002-0",
language = "English (US)",
volume = "10",
pages = "368--377",
journal = "Controlled Clinical Trials",
issn = "0197-2456",
publisher = "Elsevier BV",
number = "4",
}