Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial

被引:0
|
作者
Goodman, Phyllis J. [1 ]
Tangen, Catherine M. [1 ]
Darke, Amy K. [1 ]
Arnold, Kathryn B. [1 ]
Hartline, JoAnn [2 ]
Yee, Monica [2 ]
Anderson, Karen [2 ]
Caban-Holt, Allison [3 ]
Christen, William G. [4 ]
Cassano, Patricia A. [5 ]
Lance, Peter [6 ]
Klein, Eric A. [7 ]
Crowley, John J. [2 ]
Minasian, Lori M. [8 ]
Meyskens, Frank L. [9 ]
机构
[1] Fred Hutchinson Canc Res Ctr, SWOG Stat Ctr, 1100 Fairview Ave N,M3-C102, Seattle, WA 98109 USA
[2] SWOG Stat Ctr, Canc Res & Biostat, Seattle, WA USA
[3] Univ Kentucky, Sanders Brown Ctr Aging, Lexington, KY 40536 USA
[4] Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA
[5] Cornell Univ, Div Nutr Sci, Ithaca, NY 14853 USA
[6] Univ Arizona, Arizona Canc Ctr, Phoenix, AZ USA
[7] Cleveland Clin, Glickman Urol & Kidney Inst, Cleveland, OH 44106 USA
[8] NCI, Canc Prevent Div, Bethesda, MD 20892 USA
[9] Univ Calif Irvine, Orange, CA 92668 USA
来源
TRIALS | 2016年 / 17卷
基金
美国国家卫生研究院;
关键词
Prostate cancer; Ancillary studies; Randomized controlled trial; Study implementation; VITAMIN-E; ALZHEIMERS-DISEASE; PROSTATE-CANCER; SELENIUM; SELECT; DEMENTIA; RISK;
D O I
10.1186/s13063-016-1524-9
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Background: The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled, prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (Southwest Oncology Group). A total of 35,533 men were assigned randomly to one of four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo). At the time of the trial's development, NIH had invested substantial resources in evaluating the potential benefits of these antioxidants. To capitalize on the knowledge gained from following a large cohort of healthy, aging males on the effects of selenium and/or vitamin E, ancillary studies with other disease endpoints were solicited. Methods: Four ancillary studies were added. Each drew from the same population but had independent objectives and an endpoint other than prostate cancer. These studies fell into two categories: those prospectively enrolling and following participants (studies of Alzheimer's disease and respiratory function) and those requiring a retrospective medical record review after a reported event (cataracts/age-related macular degeneration and colorectal screening). An examination of the challenges and opportunities of adding ancillary studies is provided. The impact of the ancillary studies on adherence to SELECT was evaluated using a Cox proportional hazards model. Results: While the addition of ancillary studies appears to have improved participant adherence to the primary trial, this did not come without added complexity. Activation of the ancillary studies happened after the SELECT randomizations had begun resulting in accrual problems to some of the studies. Study site participation in the ancillary trials varied greatly and depended on the interest of the study site principal investigator. Procedures for each were integrated into the primary trial and all monitoring was done by the SELECT Data and Safety Monitoring Committee. The impact of the early closure of the primary trial was different for each of the ancillary trials. Conclusions: The ancillary studies allowed study sites to broaden the research opportunities for their participants. Their implementation was efficient because of the established infrastructure of the primary trial. Implementation of these ancillary trials took substantial planning and coordination but enriched the overall primary trial.
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页数:10
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