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2016 ; 21
(3
): 261-8
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Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a
Large Annual Oncology Meeting
#MMPMID26888691
Massey PR
; Wang R
; Prasad V
; Bates SE
; Fojo T
Oncologist
2016[Mar]; 21
(3
): 261-8
PMID26888691
show ga
BACKGROUND: Despite the ethical imperative to publish clinical trials when human
subjects are involved, such data frequently remain unpublished. The objectives
were to tabulate the rate and ascertain factors associated with eventual
publication of clinical trial results reported as abstracts in the Proceedings of
the American Society of Clinical Oncology (American Society of Clinical
Oncology). MATERIALS AND METHODS: Abstracts describing clinical trials for
patients with breast, lung, colorectal, ovarian, and prostate cancer from 2009 to
2011 were identified by using a comprehensive online database
(http://meetinglibrary.asco.org/abstracts). Abstracts included reported results
of a treatment or intervention assessed in a discrete, prospective clinical
trial. Publication status at 4-6 years was determined by using a standardized
search of PubMed. Primary outcomes were the rate of publication for abstracts of
randomized and nonrandomized clinical trials. Secondary outcomes included factors
influencing the publication of results. RESULTS: A total of 1,075 abstracts
describing 378 randomized and 697 nonrandomized clinical trials were evaluated.
Across all years, 75% of randomized and 54% of nonrandomized trials were
published, with an overall publication rate of 61%. Sample size was a
statistically significant predictor of publication for both randomized and
nonrandomized trials (odds ratio [OR] per increase of 100 participants = 1.23
[1.11-1.36], p < .001; and 1.64 [1.15-2.34], p = .006, respectively). Among
randomized studies, an industry coauthor or involvement of a cooperative group
increased the likelihood of publication (OR 2.37, p = .013; and 2.21, p = .01,
respectively). Among nonrandomized studies, phase II trials were more likely to
be published than phase I (p < .001). Use of an experimental agent was not a
predictor of publication in randomized (OR 0.76 [0.38-1.52]; p = .441) or
nonrandomized trials (OR 0.89 [0.61-1.29]; p = .532). CONCLUSION: This is the
largest reported study examining why oncology trials are not published. The data
show that 4-6 years after appearing as abstracts, 39% of oncology clinical trials
remain unpublished. Larger sample size and advanced trial phase were associated
with eventual publication; among randomized trials, an industry-affiliated author
or a cooperative group increased likelihood of publication. Unfortunately, we
found that, despite widespread recognition of the problem and the creation of
central data repositories, timely publishing of oncology clinical trials results
remains unsatisfactory.
|*Medical Oncology
[MESH]
|Antineoplastic Agents
[MESH]
|Clinical Trials as Topic/*statistics & numerical data
[MESH]