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

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

John Welsh  1 , Yuan Lu  1   2 , Sanket S Dhruva  3   4 , Behnood Bikdeli  1   5   6 , Nihar R Desai  1   2 , Liliya Benchetrit  7 , Chloe O Zimmerman  7 , Lin Mu  7 , Joseph S Ross  1   3   8   9 , Harlan M Krumholz  1   2   9
Affiliations

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

John Welsh et al. JAMA Netw Open. .

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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Conflict of interest statement

Conflict of Interest Disclosures: Drs Desai, Ross, and Krumholz reported being recipients of a research agreement from Johnson & Johnson and Medtronic, through Yale University, to develop methods of clinical trial data sharing. Drs Ross and Krumholz reported receiving research support through a grant from the US Food and Drug Administration and Medtronic to develop methods for postmarket surveillance of medical devices. Dr Ross reported receiving research grant support from the Blue Cross Blue Shield Association. Dr Bikdeli reported receiving grants from the National Heart, Lung, and Blood Institute during the conduct of the study and serving as an expert (on behalf of the plaintiff) for litigation related to inferior vena caval filters; the content of this article is not directly related to that litigation. Dr Ross reported receiving grants from the US Food and Drug Administration, the Center for Medicare & Medicaid Services, Medtronic Inc, Johnson & Johnson, and Blue Cross Blue Shield Association outside the submitted work. Dr Krumholz reported receiving grants from Medtronic, Johnson & Johnson, and the US Food and Drug Administration; receiving contracts, through Yale, from the Centers for Medicare & Medicaid Services to develop performance measures that are publicly reported; receiving personal fees from UnitedHealthcare; receiving personal fees from IBM Watson Health; receiving personal fees from Element Science; receiving personal fees from Aetna; being the founder and owner of Hugo, a personal health information platform; serving as chair for a cardiac scientific advisory board for UnitedHealth; serving as a member of the Advisory Board for Element Science and the Physician Advisory Board for Aetna; and serving as a participant/participant representative of the IBM Watson Health Life Sciences Advisory Board. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. A Mock Trial With Different Time Periods Labeled
Progression of a mock trial defining data age, data collection period, and publication time. The black lines indicate an individual patient’s own timeline throughout the study.
Figure 2.
Figure 2.. Distributions of Data Age, Enrollment Time, and Publication Time
The ends of the boxes indicate the upper and lower quartiles, so the box spans the interquartile range. The middle line indicates the median, the whiskers are the 2 lines outside the box that extend to the highest and lowest observations, and the circles indicate the extreme values of the observations.
See this image and copyright information in PMC

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