TY - JOUR
T1 - Rapid network meta-analysis using data from Food and Drug Administration approval packages is feasible but with limitations
AU - Wang, Lin
AU - Rouse, Benjamin
AU - Marks-Anglin, Arielle
AU - Duan, Rui
AU - Shi, Qiyuan
AU - Quach, Kevin
AU - Chen, Yong
AU - Cameron, Christopher
AU - Schmid, Christopher H.
AU - Li, Tianjing
N1 - Funding Information:
Funding: This work was supported by the Agency for Healthcare Research and Quality, United States [grant number 1R03HS024788-01). The sponsor was not involved in the study design; the collection, analysis, and interpretation of data; the writing of the report; or the decision to submit the article for publication. A.M.-A., R.D., and Y.C. are also supported in part by grants 1R01LM012607, 1R01AI130460, P50MH113840, R01AI116794, and 7R01LM009012 from the National Institutes of Health, United States. The authors thank the following people who provided important advice or statistical consultation for this study: Karen Robinson, Hwanhee Hong, Nicole Fusco, Zhuo Su, Anna Chaimani, Kay Dickersin, Stephan Ehrhardt, Evan Mayo-Wilson, Dave Shade, and Roberta Scherer.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2019/10
Y1 - 2019/10
N2 - Objective: To test rapid approaches that use Drugs@FDA (a public database of approved drugs) and ClinicalTrials.gov to identify trials and to compare these two sources with bibliographic databases as an evidence base for a systematic review and network meta-analysis (NMA). Study Design and Setting: We searched bibliographic databases, Drugs@FDA, and ClinicalTrials.gov for eligible trials on first-line glaucoma medications. We extracted data, assessed risk of bias, and examined the completeness and consistency of information provided by different sources. We fitted random-effects NMA models separately for trials identified from each source and for all unique trials from three sources. Results: We identified 138 unique trials including 29,394 participants on 15 first-line glaucoma medications. For a given trial, information reported was sometimes inconsistent across data sources. Journal articles provided the most information needed for a systematic review; trial registrations provided the least. Compared to an NMA including all unique trials, we were able to generate reasonably precise effect estimates and similar relative rankings for available interventions using trials from Drugs@FDA alone (but not ClinicalTrials.gov). Conclusions: A rapid NMA approach using data from Drugs@FDA is feasible but has its own limitations. Reporting of trial design and results can be improved in both the drug approval packages and on ClinicalTrials.gov.
AB - Objective: To test rapid approaches that use Drugs@FDA (a public database of approved drugs) and ClinicalTrials.gov to identify trials and to compare these two sources with bibliographic databases as an evidence base for a systematic review and network meta-analysis (NMA). Study Design and Setting: We searched bibliographic databases, Drugs@FDA, and ClinicalTrials.gov for eligible trials on first-line glaucoma medications. We extracted data, assessed risk of bias, and examined the completeness and consistency of information provided by different sources. We fitted random-effects NMA models separately for trials identified from each source and for all unique trials from three sources. Results: We identified 138 unique trials including 29,394 participants on 15 first-line glaucoma medications. For a given trial, information reported was sometimes inconsistent across data sources. Journal articles provided the most information needed for a systematic review; trial registrations provided the least. Compared to an NMA including all unique trials, we were able to generate reasonably precise effect estimates and similar relative rankings for available interventions using trials from Drugs@FDA alone (but not ClinicalTrials.gov). Conclusions: A rapid NMA approach using data from Drugs@FDA is feasible but has its own limitations. Reporting of trial design and results can be improved in both the drug approval packages and on ClinicalTrials.gov.
KW - Clinical trial
KW - ClinicalTrials.gov
KW - Comparative-effectiveness research
KW - Drugs@FDA
KW - Network meta-analysis
KW - Rapid systematic review
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U2 - 10.1016/j.jclinepi.2019.06.010
DO - 10.1016/j.jclinepi.2019.06.010
M3 - Article
C2 - 31226413
AN - SCOPUS:85068550284
VL - 114
SP - 84
EP - 94
JO - Journal of Chronic Diseases
JF - Journal of Chronic Diseases
SN - 0895-4356
ER -