Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers [临床试验结果的发表与报告：学术医疗中心的横截面分析]

• 分享：

BMJ 2016; 352 doi: http://dx.doi.org/10.1136/bmj.i637 (Published 17 February 2016)
Cite this as: BMJ 2016;352:i637

Authors
Ruijun Chen, resident physician, Nihar R Desai, assistant professor of medicine, Joseph S Ross, associate professor of medicine, Weiwei Zhang, statistician, Katherine H Chau, resident physician, Brian Wayda, resident physician, Karthik Murugiah, cardiology fellow, Daniel Y Lu, resident physician, Amit Mittal, medical student, Harlan M Krumholz, Harold H Hines Jr, professor of medicine and epidemiology and public health

Abstract
Objective: To determine rates of publication and reporting of results within two years for all completed clinical trials registered in ClinicalTrials.gov across leading academic medical centers in the United States.

Design: Cross sectional analysis.

Setting: Academic medical centers in the United States.

Participants: Academic medical centers with 40 or more completed interventional trials registered on ClinicalTrials.gov.

Methods: Using the Aggregate Analysis of ClinicalTrials.gov database and manual review, we identified all interventional clinical trials registered on ClinicalTrials.gov with a primary completion date between October 2007 and September 2010 and with a lead investigator affiliated with an academic medical center.

Main outcome measures: The proportion of trials that disseminated results, defined as publication or reporting of results on ClinicalTrials.gov, overall and within 24 months of study completion.

Results: We identified 4347 interventional clinical trials across 51 academic medical centers. Among the trials, 1005 (23%) enrolled more than 100 patients, 1216 (28%) were double blind, and 2169 (50%) were phase II through IV. Overall, academic medical centers disseminated results for 2892 (66%) trials, with 1560 (35.9%) achieving this within 24 months of study completion. The proportion of clinical trials with results disseminated within 24 months of study completion ranged from 16.2% (6/37) to 55.3% (57/103) across academic medical centers. The proportion of clinical trials published within 24 months of study completion ranged from 10.8% (4/37) to 40.3% (31/77) across academic medical centers, whereas results reporting on ClinicalTrials.gov ranged from 1.6% (2/122) to 40.7% (72/177).

Conclusions: Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers.