ClinicalTrials.gov. Prospective randomized evaluation of celecoxib integrated safety vs ibuprofen or naproxen (PRECISION), https://clinicaltrials.gov/ct2/show/NCT00346216 (2015, accessed 15 December 2015).
NissenSEWolskiK. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med2007; 356: 2457–2471 (also published correction appears in N Engl J Med 2007; 357: 100).
6.
GrahamDJOuelet-HellstromRMaCurdyTE. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA2010; 304: 411–418.
7.
GirmanCJFariesDRyanP. Pre-study feasibility and identifying sensitivity analyses for protocol pre-specification in comparative effectiveness research. J Comp Eff Res2014; 3: 259–270.
8.
RyanPBMadiganDStangPE. Empirical assessment of methods for risk identification in healthcare data: results from the experiments of the Observational Medical Outcomes Partnership. Stat Med2012; 31: 4401–4415.
9.
CurtisLHBrownJPlattR. Four health data networks illustrate the potential for a shared national multipurpose big-data network. Health Aff2014; 33: 1178–1186.
10.
PlattRKassNEMcGrawD. Ethics, regulation, and comparative effectiveness research: time for a change. JAMA2014; 311: 1497–1498.
11.
HernanMA. With great data comes great responsibility: publishing comparative effectiveness research in epidemiology. Epidemiology2011; 22: 290–291.
12.
NIH Collaboratory, Health Care Systems Research Collaboratory, https://www.nihcollaboratory.org/about-us/Pages/default.aspx (2015, accessed 11 December 2015). Mission: strengthen the national capacity to implement cost-effective large-scale research studies that engage healthcare delivery organizations as research partners.
Observational Health Data Sciences and Informatics (OHDSI), http://www.ohdsi.org/ (2015, accessed 17 December 2015).
16.
ClinicalTrials.gov. A randomized effectiveness study comparing fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) with standard treatment in chronic obstructive pulmonary disease (COPD), https://clinicaltrials.gov/ct2/show/study/NCT01551758?view=results (2015, accessed 5 January 2016).
MedDRA: a standardized medical terminology to facilitate sharing of regulatory information internationally—primarily for safety outcomes, http://www.meddra.org (2015, accessed 11 December 2015).