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JAMA Netw Open. 2018 Aug 3;1(4):e181065. doi: 10.1001/jamanetworkopen.2018.1065.

Age of Data at the Time of Publication of Contemporary Clinical Trials.

Author information

1
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.
2
Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
3
National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
4
Veterans Affairs Connecticut Healthcare System, West Haven.
5
Cardiovascular Research Foundation, New York, New York.
6
Division of Cardiology, Department of Medicine, Columbia University Medical Center/New York-Presbyterian Hospital, New York.
7
Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
8
Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
9
Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.

Abstract

Importance:

As medical knowledge and clinical practice rapidly evolve over time, there is an imperative to publish results of clinical trials in a timely way and reduce unnecessary delays.

Objectives:

To characterize the age of clinical trial data at the time of publication in journals with a high impact factor and highlight the time from final data collection to publication.

Design and Setting:

A cross-sectional analysis was conducted of all randomized clinical trials published from January 1 through December 31, 2015, in the Annals of Internal Medicine, BMJ, JAMA, JAMA Internal Medicine, Lancet, and New England Journal of Medicine. Multivariable linear regression analyses were conducted to assess whether data age (adjusted for follow-up duration) and publication time were associated with trial characteristics.

Main Outcomes and Measures:

The outcome measures were the midpoint of data collection until publication (data age), the time from first participant enrollment to last participant enrollment (enrollment time), and the time from final data collection to publication (publication time).

Results:

There were 341 clinical trials published in 2015 by the 6 journals. For assessment of the primary end point, 37 trials (10.9%) had a follow-up period of less than 1 month, 172 trials (50.4%) had a follow-up period of 1 month to 1 year, and 132 trials (38.7%) had a follow-up period of more than 1 year. For all trials, the median data age at publication was 33.9 months (interquartile range, 23.5-46.3 months). Among trials with a follow-up period of 1 month or less, the median data age was 30.6 months (interquartile range, 18.6-39.0 months). A total of 68 trials (19.9%) required more than 4 years to complete enrollment. The median time from the completion of data collection to publication was 14.8 months (interquartile range, 7.4-22.2 months); publication time was 2 or more years in 63 trials (18.5%). In multivariable regression analyses adjusted for follow-up time, inconclusive or unfavorable trial results were significantly associated with older data age (>235 days). Compared with trials funded only by private industry, trials funded by government were associated with a significantly longer time to publication (>180 days).

Conclusions and Relevance:

Clinical trials in journals with a high impact factor were published with a median data age of nearly 3 years. For a substantial proportion of studies, time for enrollment and time from completion of data collection to publication were quite long, indicating marked opportunities for improvement in clinical trials to reduce data age.

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