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. 2017 May 11;376(19):1849-1858.
doi: 10.1056/NEJMsa1603542. Epub 2017 Mar 29.

Use of the National Heart, Lung, and Blood Institute Data Repository

Sean A Coady  1 , George A Mensah  1 , Elizabeth L Wagner  1 , Miriam E Goldfarb  1 , Denise M Hitchcock  1 , Carol A Giffen  1
Affiliations

Use of the National Heart, Lung, and Blood Institute Data Repository

Sean A Coady et al. N Engl J Med. .

Abstract

Background: Research on data sharing from clinical trials has focused on elucidating perceptions, barriers, and attitudes among trialists and study participants with respect to sharing data. However, little information exists regarding utilization or associated publication of articles once clinical trial data have been widely shared.

Methods: We analyzed administrative records of investigator requests for data access, linked publications, and bibliometrics to describe the use of the National Heart, Lung, and Blood Institute data repository.

Results: From January 2000 through May 2016, a total of 370 investigators requested data from 1 or more clinical trials. Requests for trial data have been increasing, with 195 investigators (53%) initiating requests during the last 4.4 years of the study period. The predominant reason for requesting data was post hoc secondary analysis of new questions (72%), followed by analytic or statistical approaches to clinical trials (9%) and meta-analyses or pooled study research (7%). Of 172 requests with online project descriptions, only 2 requests were initiated for reanalysis of primary-outcome findings. Data from 88 of 100 available clinical trials were requested at least once, and the median time from repository availability to first request was 235 days. A total of 277 articles were published on the basis of data from 47 trials. Citation metrics from 224 articles indicated that half of the publications have cumulative citations that rank in the top 34% normalized for subject category and year of publication.

Conclusions: Demand for trial data for secondary analysis has been increasing. Requesting data for the a priori purpose of reanalysis or verification of original findings was rare.

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Figures

Figure 1
Figure 1. Cumulative Requests for Data Sets and Cumulative Number of Available Clinical Trials or Observational Studies
Data are for January 1, 2000, through May 31, 2016.
Figure 2
Figure 2. Fulfilled Data-Access Requests through May 31, 2016, According to Location of Investigator
Shown are the locations of investigators who requested data from at least one clinical trial or observational data only.
Figure 3
Figure 3. Time from Availability of Study Data in the NHLBI Data Repository until Publication of First Article Associated with a Data Request
Data were censored on May 31, 2016. NHLBI denotes National Heart, Lung, and Blood Institute.
See this image and copyright information in PMC

References

    1. Coady SA, Wagner E. Sharing individual level data from observational studies and clinical trials: a perspective from NHLBI. Trials. 2013;14:201. - PMC - PubMed
    1. Giffen CA, Carroll LE, Adams JT, Brennan SP, Coady SA, Wagner EL. Providing contemporary access to historical bio-specimen collections: development of the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) Biopreserv Biobank. 2015;13:271–9. - PMC - PubMed
    1. Biologic Specimens and Data Repository Information Coordinating Center (BioLINCC) home page. Bethesda, MD: National Heart, Lung, and Blood Institute; https://biolincc.nhlbi.nih.gov/home/
    1. Garrison NA, Sathe NA, Antommaria AH, et al. A systematic literature review of individuals' perspectives on broad consent and data sharing in the United States. Genet Med. 2016;18:663–71. - PMC - PubMed
    1. Tenopir C, Dalton ED, Allard S, et al. Changes in data sharing and data reuse practices and perceptions among scientists worldwide. PLoS One. 2015;10(8):e0134826. - PMC - PubMed

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