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Coupling Results Data from ClinicalTrials.gov and Bibliographic Databases to Accelerate Evidence Synthesis

Award Number: R01LM012976
ORGANIZATION: NATIONAL LIBRARY OF MEDICINE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/01/2019
PERIOD OF PERFORMANCE END DATE: 02/28/2025

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Coupling Results Data from ClinicalTrials.gov and Bibliographic Databases to Accelerate Evidence Synthesis - Project Summary Clinical trials are foundational to evidence-based medicine, but results reporting from trials is incomplete and frequently delayed. It is estimated that as many as half of clinical trials are not published and as many as half of published trials underreport or misreport outcomes. This type of results reporting distorts the evidence available to clinicians—particularly when it comes to assessing the safety of interventions like drugs and devices—and may place patients at unnecessary risk. There is a critical need for novel methods to identify and monitor drug safety data. Through the infrastructure provided by ClinicalTrials.gov, structured trial results (including safety findings) are now becoming available for an increasing number of trials in a comprehensive and timely fashion. However, access and use of these data in evidence synthesis tasks remain limited. ClinicalTrials.gov is the largest single registry for clinical studies worldwide and includes more than 260,000 registered studies. Of the 108,941 completed trials registered with the site, 20% have uploaded results data for a total of 7.85 million participants. Results data reported on ClinicalTrials.gov have the potential to fill gaps created by delays and biases in published articles and provide an earlier and more complete overview of available trial evidence. We propose to develop novel informatics approaches based on combinations of information retrieval and machine learning methods to facilitate access and analysis of trial results reported in this registry. Focusing on trials testing drug interventions in type 2 diabetes, obesity, and oncology, we perform this work in three specific aims: 1) Develop semi-automated trial screening for identifying and aggregating trials relevant to a clinical intervention; 2) Extract adverse event and safety outcomes data from results reported in the registry; and 3) Perform validation studies to assess detection of adverse events and performance of semi- automated meta-analyses of safety outcomes. Methods developed in this project will facilitate timely, broad- scale use of trial results reported on ClinicalTrials.gov in order to augment the availability of comprehensive and timely drug safety data. All methods will be made publicly available in order to support adverse event monitoring and systematic reviews of drug interventions.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$275 )
2025	2022	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	000	4	6/26/2025	NON-COMPETING CONTINUATION	-$275
														Subtotal = -$275

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	000	4	3/20/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $328,000 )
2022	2022	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	000	4	2/17/2022	NON-COMPETING CONTINUATION	$328,000
														Subtotal = $328,000

Issue Date FY: 2021 ( Subtotal = $328,000 )
2021	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	001	3	5/14/2021	NON-COMPETING CONTINUATION	$16,401
2021	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	000	3	2/22/2021	NON-COMPETING CONTINUATION	$311,599
														Subtotal = $328,000

Issue Date FY: 2020 ( Subtotal = $328,000 )
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	001	2	5/15/2020	NON-COMPETING CONTINUATION	$16,401
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	000	2	4/1/2020	NON-COMPETING CONTINUATION	$311,599
														Subtotal = $328,000

Issue Date FY: 2019 ( Subtotal = $347,250 )
2019	2019	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Medical Library Assistance	000	1	2/25/2019	NEW	$347,250
														Subtotal = $347,250

Grand Total All Awards = $1,330,975

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Coupling Results Data from ClinicalTrials.gov and Bibliographic Databases to Accelerate Evidence Synthesis

Award Number: R01LM012976

ORGANIZATION: NATIONAL LIBRARY OF MEDICINE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/01/2019

PERIOD OF PERFORMANCE END DATE: 02/28/2025

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