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Volumn 14, Issue 8, 2017, Pages 493-501

Efficient design of clinical trials and epidemiological research: Is it possible?

Author keywords

[No Author keywords available]

Indexed keywords

ANONYMIZATION; AWARDS AND PRIZES; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL; CONFIDENTIALITY; COST CONTROL; DRUG INDUSTRY; ELECTRONIC HEALTH RECORD; EPIDEMIOLOGICAL DATA; FUNDING; HEALTH CARE ORGANIZATION; HUMAN; PATIENT AUTONOMY; PATIENT PARTICIPATION; PATIENT SAFETY; PHYSICIAN; PRIORITY JOURNAL; PRIVACY; REGISTER; RESEARCH SUBJECT; REVIEW; STUDY DESIGN; WORKFLOW; CARDIOVASCULAR DISEASE; CLINICAL TRIAL (TOPIC); COST; COST BENEFIT ANALYSIS; ECONOMICS; METHODOLOGY; ORGANIZATION AND MANAGEMENT; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICS AND NUMERICAL DATA; TRENDS;

EID: 85018323877     PISSN: 17595002     EISSN: 17595010     Source Type: Journal    
DOI: 10.1038/nrcardio.2017.60     Document Type: Review
Times cited : (33)

References (110)
  • 1
    • 84906241463 scopus 로고    scopus 로고
    • Blood pressure-lowering treatment based on cardiovascular risk: A meta-analysis of individual patient data
    • Sundström, J. et al. Blood pressure-lowering treatment based on cardiovascular risk: a meta-analysis of individual patient data. Lancet 384, 591-598 (2014).
    • (2014) Lancet , vol.384 , pp. 591-598
    • Sundström, J.1
  • 2
    • 84864832599 scopus 로고    scopus 로고
    • The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: Meta-analysis of individual data from 27 randomised trials
    • Mihaylova, B. et al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 380, 581-590 (2012).
    • (2012) Lancet , vol.380 , pp. 581-590
    • Mihaylova, B.1
  • 3
    • 78449281377 scopus 로고    scopus 로고
    • Efficacy and safety of more intensive lowering of LDL cholesterol: A meta analysis of data from 170000 participants in 26 randomised trials
    • Baigent, C. et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta analysis of data from 170000 participants in 26 randomised trials. Lancet 376, 1670-1681 (2010).
    • (2010) Lancet , vol.376 , pp. 1670-1681
    • Baigent, C.1
  • 4
    • 13444250953 scopus 로고    scopus 로고
    • The effects of a smoking cessation intervention on 14.5-year mortality: A randomized clinical trial
    • Anthonisen, N. R. et al. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann. Intern. Med. 142, 233-239 (2005).
    • (2005) Ann. Intern. Med. , vol.142 , pp. 233-239
    • Anthonisen, N.R.1
  • 5
    • 63849141400 scopus 로고    scopus 로고
    • Preventive Services Task Force recommendation statement
    • U.S. Preventive Services Task Force. Aspirin for the prevention of cardiovascular disease: U.S.
    • U.S. Preventive Services Task Force. Aspirin for the prevention of cardiovascular disease: U.S. Preventive Services Task Force recommendation statement. Ann. Intern. Med. 150, 396-404 (2009).
    • (2009) Ann. Intern. Med. , vol.150 , pp. 396-404
  • 7
    • 34250019702 scopus 로고    scopus 로고
    • Explaining the decrease in U.S. Deaths from coronary disease, 1980-2000
    • Ford, E. S. et al. Explaining the decrease in U.S. deaths from coronary disease, 1980-2000. N. Engl. J. Med. 356, 2388-2398 (2007).
    • (2007) N. Engl. J. Med. , vol.356 , pp. 2388-2398
    • Ford, E.S.1
  • 8
    • 40949112288 scopus 로고    scopus 로고
    • Sensible approaches for reducing clinical trial costs
    • Eisenstein, E. L. et al. Sensible approaches for reducing clinical trial costs. Clin. Trials 5, 75-84 (2008).
    • (2008) Clin. Trials , vol.5 , pp. 75-84
    • Eisenstein, E.L.1
  • 9
    • 4143112434 scopus 로고    scopus 로고
    • Transforming the scientific, health care, and sociopolitical culture of an entire country through clinical research: The story of GISSI
    • Yusuf, S. Transforming the scientific, health care, and sociopolitical culture of an entire country through clinical research: the story of GISSI. Am. Heart J. 148, 193-195 (2004).
    • (2004) Am. Heart J. , vol.148 , pp. 193-195
    • Yusuf, S.1
  • 10
    • 84868335534 scopus 로고    scopus 로고
    • Transforming clinical trials in cardiovascular disease: Mission critical for health and economic well-being
    • Antman, E. M. & Harrington, R. A. Transforming clinical trials in cardiovascular disease: mission critical for health and economic well-being. JAMA 308, 1743-1744 (2012).
    • (2012) JAMA , vol.308 , pp. 1743-1744
    • Antman, E.M.1    Harrington, R.A.2
  • 11
    • 0037031061 scopus 로고    scopus 로고
    • Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: A randomised placebo-controlled trial
    • Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 360, 7-22 (2002).
    • (2002) Lancet , vol.360 , pp. 7-22
  • 12
    • 4143139819 scopus 로고    scopus 로고
    • Participation versus education: The GISSI story and beyond
    • Tavazzi, L., Maggioni, A. P. & Tognoni, G. Participation versus education: the GISSI story and beyond. Am. Heart J. 148, 222-229 (2004).
    • (2004) Am. Heart J. , vol.148 , pp. 222-229
    • Tavazzi, L.1    Maggioni, A.P.2    Tognoni, G.3
  • 14
    • 84945897626 scopus 로고    scopus 로고
    • Price indexes for clinical trial research: A feasibility study
    • Berndt, E. R. & Cockburn, I. M. Price indexes for clinical trial research: a feasibility study. National Bureau of Economic Research http://www.nber.org/papers/w18918.pdf (2013).
    • (2013) National Bureau of Economic Research
    • Berndt, E.R.1    Cockburn, I.M.2
  • 15
    • 34447314711 scopus 로고    scopus 로고
    • Clinical trials bureaucracy: Unintended consequences of well-intentioned policy
    • Califf, R. M. Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin. Trials 3, 496-502 (2006).
    • (2006) Clin. Trials , vol.3 , pp. 496-502
    • Califf, R.M.1
  • 16
    • 84900485488 scopus 로고    scopus 로고
    • Improving protocol design feasibility to drive drug development economics and performance
    • Getz, K. Improving protocol design feasibility to drive drug development economics and performance. Int. J. Environ. Res. Public Health 11, 5069-5080 (2014).
    • (2014) Int. J. Environ. Public Health , vol.11 , pp. 5069-5080
    • Getz, K.1
  • 17
    • 84887501554 scopus 로고    scopus 로고
    • When it comes to trials, do we get what we pay for?
    • Devereaux, P. J. & Yusuf, S. When it comes to trials, do we get what we pay for? N. Engl. J. Med. 369, 1962-1963 (2013).
    • (2013) N. Engl. J. Med. , vol.369 , pp. 1962-1963
    • Devereaux, P.J.1    Yusuf, S.2
  • 18
    • 84863393297 scopus 로고    scopus 로고
    • Impediments to clinical research in the United States
    • Kramer, J. M., Smith, P. B. & Califf, R. M. Impediments to clinical research in the United States. Clin. Pharmacol. Ther. 91, 535-541 (2012).
    • (2012) Clin. Pharmacol. Ther. , vol.91 , pp. 535-541
    • Kramer, J.M.1    Smith, P.B.2    Califf, R.M.3
  • 19
    • 84889584752 scopus 로고    scopus 로고
    • Stifling new cures: The true cost of lengthy clinical drug trials
    • Roy, A. S. A. Stifling new cures: the true cost of lengthy clinical drug trials. Manhattan Institute https://www.manhattan-institute.org/html/stifling-new-cures-true-cost-lengthy-clinical-drug-trials-6013.html (2012).
    • (2012) Manhattan Institute
    • Roy, A.S.A.1
  • 20
    • 84920973827 scopus 로고    scopus 로고
    • The anatomy of medical research
    • Moses, H. et al. The anatomy of medical research. JAMA 313, 174-189 (2015).
    • (2015) JAMA , vol.313 , pp. 174-189
    • Moses, H.1
  • 21
    • 85024367652 scopus 로고    scopus 로고
    • CDER new drug review: 2016 update
    • FDA/CentersOffices/Officeof Medical Productsand Tobacco/CDER/UCM533192.pdf
    • Jenkins, J. K. CDER new drug review: 2016 update. U.S. Food and Drug Administration https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM533192.pdf (2016).
    • (2016) U.S. Food and Drug Administration
    • Jenkins, J.K.1
  • 23
    • 84868324287 scopus 로고    scopus 로고
    • Time for a creative transformation of epidemiology in the United States
    • Lauer, M. S. Time for a creative transformation of epidemiology in the United States. JAMA 308, 1804-1805 (2012).
    • (2012) JAMA , vol.308 , pp. 1804-1805
    • Lauer, M.S.1
  • 24
    • 84876517223 scopus 로고    scopus 로고
    • Transforming epidemiology for 21st century medicine and public health
    • Khoury, M. J. et al. Transforming epidemiology for 21st century medicine and public health. Cancer Epidemiol. Biomarkers Prev. 22, 508-516 (2013).
    • (2013) Cancer Epidemiol. Biomarkers Prev. , vol.22 , pp. 508-516
    • Khoury, M.J.1
  • 25
    • 84928037308 scopus 로고    scopus 로고
    • The National Children''s Study - End or new beginning?
    • Landrigan, P. J. & Baker, D. B. The National Children''s Study - end or new beginning? N. Engl. J. Med. 372, 1486-1487 (2015).
    • (2015) N. Engl. J. Med. , vol.372 , pp. 1486-1487
    • Landrigan, P.J.1    Baker, D.B.2
  • 26
    • 61449263596 scopus 로고    scopus 로고
    • Scientific evidence underlying the ACC/AHA clinical practice guidelines
    • Tricoci, P. et al. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA 301, 831-841 (2009).
    • (2009) JAMA , vol.301 , pp. 831-841
    • Tricoci, P.1
  • 27
    • 84861889904 scopus 로고    scopus 로고
    • A policy for science
    • Lauer, M. S. A policy for science. J. Am. Coll. Cardiol. 59, 2154-2156 (2012).
    • (2012) J. Am. Coll. Cardiol. , vol.59 , pp. 2154-2156
    • Lauer, M.S.1
  • 28
    • 85006070909 scopus 로고    scopus 로고
    • Transforming evidence generation to support health and health care decisions
    • Califf, R. M. et al. Transforming evidence generation to support health and health care decisions. N. Engl. J. Med. 375, 2395-2400 (2016).
    • (2016) N. Engl. J. Med. , vol.375 , pp. 2395-2400
    • Califf, R.M.1
  • 30
    • 84995810464 scopus 로고    scopus 로고
    • Toward a new era of trust and transparency in clinical trials
    • Hudson, K., Lauer, M. & Collins, F. Toward a new era of trust and transparency in clinical trials. JAMA 316, 1353-1354 (2016).
    • (2016) JAMA , vol.316 , pp. 1353-1354
    • Hudson, K.1    Lauer, M.2    Collins, F.3
  • 31
    • 84876665206 scopus 로고    scopus 로고
    • Power failure: Why small sample size undermines the reliability of neuroscience
    • Button, K. S. et al. Power failure: why small sample size undermines the reliability of neuroscience. Nat. Rev. Neurosci. 14, 365-376 (2013).
    • (2013) Nat. Rev. Neurosci. , vol.14 , pp. 365-376
    • Button, K.S.1
  • 32
    • 84862955602 scopus 로고    scopus 로고
    • Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis
    • Ross, J. S. et al. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ 344, d7292 (2012).
    • (2012) BMJ , vol.344 , pp. d7292
    • Ross, J.S.1
  • 33
    • 84960083687 scopus 로고    scopus 로고
    • Publication and reporting of clinical trial results: Cross sectional analysis across academic medical centers
    • Chen, R. et al. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ 352 i637 (2016).
    • (2016) BMJ 352 i637
    • Chen, R.1
  • 34
    • 84894121805 scopus 로고    scopus 로고
    • Publication of trials funded by the National Heart, Lung, and Blood Institute
    • Gordon, D. J. & Lauer, M. S. Publication of trials funded by the National Heart, Lung, and Blood Institute. N. Engl. J. Med. 370, 782 (2014).
    • (2014) N. Engl. J. Med. , vol.370 , pp. 782
    • Gordon, D.J.1    Lauer, M.S.2
  • 35
    • 84978001891 scopus 로고    scopus 로고
    • Publication speed, reporting metrics, and citation impact of cardiovascular trials supported by the National Heart, Lung, and Blood Institute
    • Gordon, D., Cooper-Arnold, K., Lauer, M., Cooper-Arnold, K. & Lauer, M. Publication speed, reporting metrics, and citation impact of cardiovascular trials supported by the National Heart, Lung, and Blood Institute. J. Am. Heart Assoc. 4, e002292 (2015).
    • (2015) J. Am. Heart Assoc. , vol.4 , pp. e002292
    • Gordon, D.1    Cooper-Arnold, K.2    Lauer, M.3    Cooper-Arnold, K.4    Lauer, M.5
  • 36
    • 84965106795 scopus 로고    scopus 로고
    • NIH tackles clinical trial shortcomings
    • Mullard, A. NIH tackles clinical trial shortcomings. Nat. Rev. Drug Discov. 15, 297-298 (2016).
    • (2016) Nat. Rev. Drug Discov. , vol.15 , pp. 297-298
    • Mullard, A.1
  • 37
    • 68149163080 scopus 로고    scopus 로고
    • The impact of national institutes of health funding on U.S. Cardiovascular disease research
    • Lyubarova, R., Itagaki, B. K. & Itagaki, M. W. The impact of National Institutes of Health funding on U.S. cardiovascular disease research. PLoS ONE 4, e6425 (2009).
    • (2009) PLoS ONE , vol.4 , pp. e6425
    • Lyubarova, R.1    Itagaki, B.K.2    Itagaki, M.W.3
  • 38
    • 84960398844 scopus 로고    scopus 로고
    • Key cost drivers of pharmaceutical clinical trials in the United States
    • Sertkaya, A., Wong, H.-H., Jessup, A. & Beleche, T. Key cost drivers of pharmaceutical clinical trials in the United States. Clin. Trials 13, 117-126 (2016).
    • (2016) Clin. Trials , vol.13 , pp. 117-126
    • Sertkaya, A.1    Wong, H.-H.2    Jessup, A.3    Beleche, T.4
  • 39
    • 84898748408 scopus 로고    scopus 로고
    • The imperative of overcoming barriers to the conduct of large, simple trials
    • Eapen, Z. J., Lauer, M. S. & Temple, R. J. The imperative of overcoming barriers to the conduct of large, simple trials. JAMA 311, 1397-1398 (2014).
    • (2014) JAMA , vol.311 , pp. 1397-1398
    • Eapen, Z.J.1    Lauer, M.S.2    Temple, R.J.3
  • 40
    • 84907308073 scopus 로고    scopus 로고
    • Clinical trial participation after myocardial infarction in a national cardiovascular data registry
    • Udell, J. A. et al. Clinical trial participation after myocardial infarction in a national cardiovascular data registry. JAMA 312, 841-843 (2014).
    • (2014) JAMA , vol.312 , pp. 841-843
    • Udell, J.A.1
  • 41
    • 67650001781 scopus 로고    scopus 로고
    • The obligation to participate in biomedical research
    • Schaefer, G. O., Emanuel, E. J. & Wertheimer, A. The obligation to participate in biomedical research. JAMA 302, 67-72 (2009).
    • (2009) JAMA , vol.302 , pp. 67-72
    • Schaefer, G.O.1    Emanuel, E.J.2    Wertheimer, A.3
  • 42
    • 2642573558 scopus 로고    scopus 로고
    • Participation in cancer clinical trials: Race-, sex-, and age-based disparities
    • Murthy, V. H., Krumholz, H. M. & Gross, C. P. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA 291, 2720-2726 (2004).
    • (2004) JAMA , vol.291 , pp. 2720-2726
    • Murthy, V.H.1    Krumholz, H.M.2    Gross, C.P.3
  • 43
    • 84861860498 scopus 로고    scopus 로고
    • Bad science and breast cancer
    • Brownlee, S. & Winters, D. Bad science and breast cancer. Discover Magazine http://discovermagazine.com/2002/aug/featbad (2002).
    • (2002) Discover Magazine
    • Brownlee, S.1    Winters, D.2
  • 44
    • 43249087876 scopus 로고    scopus 로고
    • A bruising battle over lung scans
    • Marshall, E. A. Medicine. A bruising battle over lung scans. Science 320, 600-603 (2008).
    • (2008) Science , vol.320 , pp. 600-603
    • Marshall, E.1    Medicine, A.2
  • 45
    • 70450032522 scopus 로고    scopus 로고
    • Clinical research sites - The underappreciated component of the clinical research system
    • Califf, R. M. Clinical research sites - the underappreciated component of the clinical research system. JAMA 302, 2025-2027 (2009).
    • (2009) JAMA , vol.302 , pp. 2025-2027
    • Califf, R.M.1
  • 46
    • 84898651926 scopus 로고    scopus 로고
    • Comparative effectiveness questions in oncology
    • Mailankody, S. & Prasad, V. Comparative effectiveness questions in oncology. N. Engl. J. Med. 370, 1478-1481 (2014).
    • (2014) N. Engl. J. Med. , vol.370 , pp. 1478-1481
    • Mailankody, S.1    Prasad, V.2
  • 47
    • 85024381626 scopus 로고    scopus 로고
    • Tufts CSDD impact report. Current investigator landscape poses a growing challenge for sponsors
    • Tufts Center for Drug Development
    • Tufts Center for Drug Development. Tufts CSDD impact report. Current investigator landscape poses a growing challenge for sponsors. Tufts University http://csdd.tufts.edu/reports/purchase-single-impact- report?issue=Vol11%20No1 (2009).
    • (2009) Tufts University
  • 48
    • 85024385666 scopus 로고    scopus 로고
    • Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation, English, R., Lebovitz, Y. & Giffin, R (National Academies Press)
    • Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation, English, R., Lebovitz, Y. & Giffin, R. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary (National Academies Press, 2010).
    • (2010) Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary
  • 49
    • 84887437641 scopus 로고    scopus 로고
    • Publication of trials funded by the National Heart, Lung, and Blood Institute
    • Gordon, D. et al. Publication of trials funded by the National Heart, Lung, and Blood Institute. N. Engl. J. Med. 369, 1926-1934 (2013).
    • (2013) N. Engl. J. Med. , vol.369 , pp. 1926-1934
    • Gordon, D.1
  • 50
    • 84882985976 scopus 로고    scopus 로고
    • Medical research: Trial unpredictability yields predictable therapy gains
    • Djulbegovic, B., Kumar, A., Glasziou, P., Miladinovic, B. & Chalmers, I. Medical research: trial unpredictability yields predictable therapy gains. Nature 500, 395-396 (2013).
    • (2013) Nature , vol.500 , pp. 395-396
    • Djulbegovic, B.1    Kumar, A.2    Glasziou, P.3    Miladinovic, B.4    Chalmers, I.5
  • 51
    • 85024387918 scopus 로고    scopus 로고
    • National Institutes of Health. US GAO-16-304 report. Additional data would enhance the stewardship of clinical trials across the agency
    • National Institutes of Health. US GAO-16-304 report. Additional data would enhance the stewardship of clinical trials across the agency. U.S. Government Accountability Office http://www.gao.gov/assets/680/675711.pdf (2016).
    • (2016) U.S. Government Accountability Office
  • 52
    • 85024371296 scopus 로고    scopus 로고
    • CTSA consortium tackling clinical trial recruitment roadblocks
    • National Institutes of Health
    • National Institutes of Health. CTSA consortium tackling clinical trial recruitment roadblocks. National Institutes of Health https://ncats.nih.gov/pubs/features/ctsa-act (2015).
    • (2015) National Institutes of Health
  • 53
    • 85024385042 scopus 로고    scopus 로고
    • SMART IRB.
    • SMART IRB. About SMART IRB. https://smartirb.org/about-us/(2016).
    • (2016) About SMART IRB
  • 54
    • 84904179088 scopus 로고    scopus 로고
    • The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: Evaluations of two exemplar trials
    • van Staa, T.-P. et al. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials. Health Technol. Assess. 18, 1-146 (2014).
    • (2014) Health Technol. Assess. , vol.18 , pp. 1-146
    • Van Staa, T.-P.1
  • 55
    • 84868324234 scopus 로고    scopus 로고
    • The future of cardiovascular clinical research: Informatics, clinical investigators, and community engagement
    • Califf, R. M., Sanderson, I. & Miranda, M. L. The future of cardiovascular clinical research: informatics, clinical investigators, and community engagement. JAMA 308, 1747-1748 (2012).
    • (2012) JAMA , vol.308 , pp. 1747-1748
    • Califf, R.M.1    Sanderson, I.2    Miranda, M.L.3
  • 56
    • 79959220310 scopus 로고    scopus 로고
    • A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen
    • Fiore, L. D. et al. A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen. Clin. Trials 8, 183-195 (2011).
    • (2011) Clin. Trials , vol.8 , pp. 183-195
    • Fiore, L.D.1
  • 58
    • 78650139118 scopus 로고    scopus 로고
    • Thrombus aspiration in ST-elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale
    • Frobert, O. et al. Thrombus aspiration in ST-elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale. Am. Heart. J. 160, 1042-1048 (2010).
    • (2010) Am. Heart. J. , vol.160 , pp. 1042-1048
    • Frobert, O.1
  • 59
    • 84886258945 scopus 로고    scopus 로고
    • Thrombus aspiration during ST-segment elevation myocardial infarction
    • Frobert, O. et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N. Engl. J. Med. 369, 1587-1597 (2013).
    • (2013) N. Engl. J. Med. , vol.369 , pp. 1587-1597
    • Frobert, O.1
  • 60
    • 84927144730 scopus 로고    scopus 로고
    • Randomized trial of primary PCI with or without routine manual thrombectomy
    • Jolly, S. S. et al. Randomized trial of primary PCI with or without routine manual thrombectomy. N. Engl. J. Med. 372, 1389-1398 (2015).
    • (2015) N. Engl. J. Med. , vol.372 , pp. 1389-1398
    • Jolly, S.S.1
  • 61
    • 84886246781 scopus 로고    scopus 로고
    • The randomized registry trial - The next disruptive technology in clinical research?
    • Lauer, M. S. & D''Agostino, R. B. The randomized registry trial - the next disruptive technology in clinical research? N. Engl. J. Med. 369, 1579-1581 (2013).
    • (2013) N. Engl. J. Med. , vol.369 , pp. 1579-1581
    • Lauer, M.S.1    D''Agostino, R.B.2
  • 62
    • 84902674498 scopus 로고    scopus 로고
    • Electronic health records for intervention research: A cluster randomized trial to reduce antibiotic prescribing in primary care (eCRT Study)
    • Gulliford, M. C. et al. Electronic health records for intervention research: a cluster randomized trial to reduce antibiotic prescribing in primary care (eCRT Study). Ann. Fam. Med. 12, 344-351 (2014).
    • (2014) Ann. Fam. Med. , vol.12 , pp. 344-351
    • Gulliford, M.C.1
  • 63
    • 84902663186 scopus 로고    scopus 로고
    • Cluster randomized trials utilizing primary care electronic health records: Methodological issues in design, conduct, and analysis (eCRT Study)
    • Gulliford, M. C. et al. Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study). Trials 15, 220 (2014).
    • (2014) Trials , vol.15 , pp. 220
    • Gulliford, M.C.1
  • 64
    • 84903784168 scopus 로고    scopus 로고
    • Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records
    • Dregan, A. et al. Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records. Stroke 45, 2066-2071 (2014).
    • (2014) Stroke , vol.45 , pp. 2066-2071
    • Dregan, A.1
  • 65
    • 84866866134 scopus 로고    scopus 로고
    • Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT Study): Study protocol for a randomized controlled trial
    • Dregan, A. et al. Cluster randomized trial in the general practice research database: 2. secondary prevention after first stroke (eCRT Study): study protocol for a randomized controlled trial. Trials 13, 181 (2012).
    • (2012) Trials , vol.13 , pp. 181
    • Dregan, A.1
  • 66
    • 84906345521 scopus 로고    scopus 로고
    • A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: The SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial
    • Rao, S. V. et al. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial. JACC Cardiovasc. Interv. 7, 857-867 (2014).
    • (2014) JACC Cardiovasc. Interv , vol.7 , pp. 857-867
    • Rao, S.V.1
  • 67
    • 84887855887 scopus 로고    scopus 로고
    • Embedding cardiovascular research into practice
    • Califf, R. M. & Platt, R. Embedding cardiovascular research into practice. JAMA 310, 2037-2038 (2013).
    • (2013) JAMA , vol.310 , pp. 2037-2038
    • Califf, R.M.1    Platt, R.2
  • 68
    • 85024366722 scopus 로고    scopus 로고
    • Demonstration projects
    • NIH Collaboratory. Demonstration projects. NIH Collaboratory https://www.nihcollaboratory.org/demonstration-projects/Pages/default.aspx (2016).
    • (2016) NIH Collaboratory
    • Collaboratory, N.1
  • 69
    • 85024400899 scopus 로고    scopus 로고
    • The Vitamin D and omega-3 trial
    • VITAL
    • VITAL. The VITamin D and OmegA-3 TriaL. VITAL http://www.vitalstudy.org (2016).
    • (2016) VITAL
  • 70
    • 84874441236 scopus 로고    scopus 로고
    • Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): A randomised non-inferiority trial
    • Christiansen, E. H. et al. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial. Lancet 381, 661-669 (2013).
    • (2013) Lancet , vol.381 , pp. 661-669
    • Christiansen, E.H.1
  • 71
    • 0034737272 scopus 로고    scopus 로고
    • Epidemiology When an entire country is a cohort
    • Frank, L. Epidemiology. When an entire country is a cohort. Science 287, 2398-2399 (2000).
    • (2000) Science , vol.287 , pp. 2398-2399
    • Frank, L.1
  • 72
    • 0032999949 scopus 로고    scopus 로고
    • The Danish National Hospital Register. A valuable source of data for modern health sciences
    • Andersen, T. F., Madsen, M., Jørgensen, J., Mellemkjoer, L. & Olsen, J. H. The Danish National Hospital Register. A valuable source of data for modern health sciences. Dan. Med. Bull. 46, 263-268 (1999).
    • (1999) Dan. Med. Bull. , vol.46 , pp. 263-268
    • Andersen, T.F.1    Madsen, M.2    Jørgensen, J.3    Mellemkjoer, L.4    Olsen, J.H.5
  • 73
    • 84945219289 scopus 로고    scopus 로고
    • The ADAPTABLE trial and PCORnet: Shining light on a new research paradigm
    • Hernandez, A. F., Fleurence, R. L. & Rothman, R. L. The ADAPTABLE trial and PCORnet: shining light on a new research paradigm. Ann. Intern. Med. http://dx.doi.org/10.7326/M15-1460 (2015).
    • (2015) Ann. Intern. Med.
    • Hernandez, A.F.1    Fleurence, R.L.2    Rothman, R.L.3
  • 74
    • 84995550165 scopus 로고    scopus 로고
    • Effect of short-term versus long-term blood storage on mortality after transfusion
    • Heddle, N. M. et al. Effect of short-term versus long-term blood storage on mortality after transfusion. N. Engl. J. Med. 375, 1937-1945 (2016).
    • (2016) N. Engl. J. Med. , vol.375 , pp. 1937-1945
    • Heddle, N.M.1
  • 75
    • 84855171302 scopus 로고    scopus 로고
    • Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy
    • Boden, W. E. et al. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N. Engl. J. Med. 365, 2255-2267 (2011).
    • (2011) N. Engl. J. Med. , vol.365 , pp. 2255-2267
    • Boden, W.E.1
  • 76
    • 82555196119 scopus 로고    scopus 로고
    • Full coverage for preventive medications after myocardial infarction
    • Choudhry, N. K. et al. Full coverage for preventive medications after myocardial infarction. N. Engl. J. Med. 365, 2088-2097 (2011).
    • (2011) N. Engl. J. Med. , vol.365 , pp. 2088-2097
    • Choudhry, N.K.1
  • 77
    • 84878834991 scopus 로고    scopus 로고
    • Targeted versus universal decolonization to prevent ICU infection
    • Huang, S. S. et al. Targeted versus universal decolonization to prevent ICU infection. N. Engl. J. Med. 368, 2255-2265 (2013).
    • (2013) N. Engl. J. Med. , vol.368 , pp. 2255-2265
    • Huang, S.S.1
  • 78
    • 75749090779 scopus 로고    scopus 로고
    • Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: A randomized controlled trial
    • Wilber, D. J. et al. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA 303, 333-340 (2010).
    • (2010) JAMA , vol.303 , pp. 333-340
    • Wilber, D.J.1
  • 79
    • 85015230829 scopus 로고    scopus 로고
    • How economics can shape precision medicines
    • Stern, A. D., Alexander, B. M. & Chandra, A. How economics can shape precision medicines. Science 355, 1131-1133 (2017).
    • (2017) Science , vol.355 , pp. 1131-1133
    • Stern, A.D.1    Alexander, B.M.2    Chandra, A.3
  • 80
    • 84898713808 scopus 로고    scopus 로고
    • Spironolactone for heart failure with preserved ejection fraction
    • Pitt, B. et al. Spironolactone for heart failure with preserved ejection fraction. N. Engl. J. Med. 370, 1383-1392 (2014).
    • (2014) N. Engl. J. Med. , vol.370 , pp. 1383-1392
    • Pitt, B.1
  • 81
  • 82
    • 84925581450 scopus 로고    scopus 로고
    • Regional variation in patients and outcomes in the treatment of preserved cardiac function heart failure with an aldosterone antagonist (TOPCAT) trial
    • Pfeffer, M. A. et al. Regional variation in patients and outcomes in the treatment of preserved cardiac function heart failure with an aldosterone antagonist (TOPCAT) trial. Circulation 131, 34-42 (2015).
    • (2015) Circulation , vol.131 , pp. 34-42
    • Pfeffer, M.A.1
  • 83
    • 78649440889 scopus 로고    scopus 로고
    • Enhancing the feasibility of large cohort studies
    • Manolio, T. A. & Collins, R. Enhancing the feasibility of large cohort studies. JAMA 304, 2290-2291 (2010).
    • (2010) JAMA , vol.304 , pp. 2290-2291
    • Manolio, T.A.1    Collins, R.2
  • 84
    • 84957436835 scopus 로고    scopus 로고
    • Million Veteran Program: A mega-biobank to study genetic influences on health and disease
    • Gaziano, J. M. et al. Million Veteran Program: a mega-biobank to study genetic influences on health and disease. J. Clin. Epidemiol. 70, 214-223 (2016).
    • (2016) J. Clin. Epidemiol. , vol.70 , pp. 214-223
    • Gaziano, J.M.1
  • 86
    • 85024392757 scopus 로고    scopus 로고
    • Working group the precision medicine initiative cohort program - Building a research foundation for 21st century medicine
    • Precision Medicine Initiative (PMI)
    • Precision Medicine Initiative (PMI) Working Group. The Precision Medicine Initiative cohort program - building a research foundation for 21st century medicine. National Institutes of Health https://www. nih.gov/sites/default/files/research-training/initiatives/pmi/pmi-working-group-report-20150917-2.pdf (2015).
    • (2015) National Institutes of Health
  • 87
    • 84923762812 scopus 로고    scopus 로고
    • New initiative on precision medicine
    • Collins, F. S. & Varmus, H. A. New initiative on precision medicine. N. Engl. J. Med. 372, 793-795 (2015).
    • (2015) N. Engl. J. Med. , vol.372 , pp. 793-795
    • Collins, F.S.1    Varmus, H.A.2
  • 88
    • 84859495993 scopus 로고    scopus 로고
    • Cardiovascular epidemiology in a changing world - Challenges to investigators and the National Heart, Lung, and Blood Institute
    • Sorlie, P. D., Bild, D. E. & Lauer, M. S. Cardiovascular epidemiology in a changing world - challenges to investigators and the National Heart, Lung, and Blood Institute. Am. J. Epidemiol. 175, 597-601 (2012).
    • (2012) Am. J. Epidemiol. , vol.175 , pp. 597-601
    • Sorlie, P.D.1    Bild, D.E.2    Lauer, M.S.3
  • 89
    • 84947997842 scopus 로고    scopus 로고
    • Impact of National Heart, Lung, and Blood Institute-supported cardiovascular epidemiology research, 1998 to 2012
    • Fabsitz, R. R. et al. Impact of National Heart, Lung, and Blood Institute-supported cardiovascular epidemiology research, 1998 to 2012. Circulation 132, 2028-2033 (2015).
    • (2015) Circulation , vol.132 , pp. 2028-2033
    • Fabsitz, R.R.1
  • 90
    • 84924416546 scopus 로고    scopus 로고
    • Strategic transformation of population studies: Recommendations of the working group on epidemiology and population sciences from the national heart, lung, and blood advisory council and board of external experts
    • Roger, V. L. et al. Strategic transformation of population studies: recommendations of the working group on epidemiology and population sciences From the National Heart, Lung, and Blood Advisory Council and Board of External Experts. Am. J. Epidemiol. 181, 363-368 (2015).
    • (2015) Am. J. Epidemiol. , vol.181 , pp. 363-368
    • Roger, V.L.1
  • 91
    • 84939140053 scopus 로고    scopus 로고
    • News from the NIH: Potential contributions of the behavioral and social sciences to the precision medicine initiative
    • Riley, W., Nilsen, W., Manolio, T., Masys, D. & Lauer, M. News from the NIH: potential contributions of the behavioral and social sciences to the precision medicine initiative. Transl Behav. Med. 5, 243-246 (2015).
    • (2015) Transl Behav. Med. , vol.5 , pp. 243-246
    • Riley, W.1    Nilsen, W.2    Manolio, T.3    Masys, D.4    Lauer, M.5
  • 92
    • 84898730677 scopus 로고    scopus 로고
    • Use of Medicare data to identify coronary heart disease outcomes in the Women''s Health Initiative
    • Hlatky, M. A. et al. Use of Medicare data to identify coronary heart disease outcomes in the Women''s Health Initiative. Circ. Cardiovasc. Qual. Outcomes 7, 157-162 (2014).
    • (2014) Circ. Cardiovasc. Qual. Outcomes , vol.7 , pp. 157-162
    • Hlatky, M.A.1
  • 93
    • 84958877160 scopus 로고    scopus 로고
    • The FDA''s sentinel initiative - A comprehensive approach to medical product surveillance
    • Ball, R., Robb, M., Anderson, S. A. & Dal Pan, G. The FDA''s sentinel initiative - a comprehensive approach to medical product surveillance. Clin. Pharmacol. Ther. 99, 265-268 (2016).
    • (2016) Clin. Pharmacol. Ther. , vol.99 , pp. 265-268
    • Ball, R.1    Robb, M.2    Anderson, S.A.3    Dal Pan, G.4
  • 95
    • 85024367773 scopus 로고    scopus 로고
    • Accrual of human subjects (milestones) policy
    • National Heart Lung Blood Institute
    • National Heart, Lung and Blood Institute. Accrual of human subjects (milestones) policy. National Institutes of Health http://www.nhlbi.nih.gov/research/funding/human-subjects/accrual-guidelines (2009).
    • (2009) National Institutes of Health
  • 96
    • 84896831150 scopus 로고    scopus 로고
    • Determination of the role of oxygen in suspected acute myocardial infarction (DETO2X-AMI trial
    • Hofmann, R. et al. Determination of the role of oxygen in suspected acute myocardial infarction (DETO2X-AMI trial). Am. Heart J. 167, 322-328 (2013).
    • (2013) Am. Heart J. , vol.167 , pp. 322-328
    • Hofmann, R.1
  • 97
    • 68249130994 scopus 로고    scopus 로고
    • Rethinking randomized clinical trials for comparative effectiveness research: The need for transformational change
    • Luce, B. R. et al. Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann. Intern. Med. 151, 206-209 (2009).
    • (2009) Ann. Intern. Med. , vol.151 , pp. 206-209
    • Luce, B.R.1
  • 98
    • 84929911356 scopus 로고    scopus 로고
    • Cluster randomized trials: Evaluating treatments applied to groups
    • Meurer, W. J. & Lewis, R. J. Cluster randomized trials: evaluating treatments applied to groups. JAMA 313, 2068-2069 (2015).
    • (2015) JAMA , vol.313 , pp. 2068-2069
    • Meurer, W.J.1    Lewis, R.J.2
  • 99
    • 85006013324 scopus 로고    scopus 로고
    • NIH policy on single-IRB review - A new era in multicenter studies
    • Ervin, A.-M., Taylor, H. A. & Ehrhardt, S. NIH policy on single-IRB review - a new era in multicenter studies. N. Engl. J. Med. 375, 2315-2317 (2016).
    • (2016) N. Engl. J. Med. , vol.375 , pp. 2315-2317
    • Ervin, A.-M.1    Taylor, H.A.2    Ehrhardt, S.3
  • 100
    • 84904393401 scopus 로고    scopus 로고
    • Engaging patients and stakeholders in research proposal review: The patient-centered outcomes
    • research institute
    • Fleurence, R. L. et al. Engaging patients and stakeholders in research proposal review: the patient-centered outcomes research institute. Ann. Intern. Med. 161, 122-130 (2014).
    • (2014) Ann. Intern. Med. , vol.161 , pp. 122-130
    • Fleurence, R.L.1
  • 101
    • 84856218422 scopus 로고    scopus 로고
    • Clinical trial implementation and recruitment: Lessons learned from the early closure of a randomized clinical trial
    • Peters-Lawrence, M. H. et al. Clinical trial implementation and recruitment: lessons learned from the early closure of a randomized clinical trial. Contemp. Clin. Trials 33, 291-297 (2012).
    • (2012) Contemp. Clin. Trials , vol.33 , pp. 291-297
    • Peters-Lawrence, M.H.1
  • 102
    • 80053345207 scopus 로고    scopus 로고
    • More time for research: Fund people not projects
    • Ioannidis, J. P. More time for research: fund people not projects. Nature 477, 529-531 (2011).
    • (2011) Nature , vol.477 , pp. 529-531
    • Ioannidis, J.P.1
  • 103
    • 84905915819 scopus 로고    scopus 로고
    • Assessing value in biomedical research: The PQRST of appraisal and reward
    • Ioannidis, J. P. & Khoury, M. J. Assessing value in biomedical research: the PQRST of appraisal and reward. JAMA 312, 483-484 (2014).
    • (2014) JAMA , vol.312 , pp. 483-484
    • Ioannidis, J.P.1    Khoury, M.J.2
  • 104
    • 77449109638 scopus 로고    scopus 로고
    • Costs and benefits of the National Cancer Institute central institutional review board
    • Wagner, T. H., Murray, C., Goldberg, J., Adler, J. M. & Abrams, J. Costs and benefits of the National Cancer Institute central institutional review board. J. Clin. Oncol. 28, 662-666 (2010).
    • (2010) J. Clin. Oncol. , vol.28 , pp. 662-666
    • Wagner, T.H.1    Murray, C.2    Goldberg, J.3    Adler, J.M.4    Abrams, J.5
  • 105
    • 84995543060 scopus 로고    scopus 로고
    • Trial reporting in ClinicalTrials.gov - The final rule
    • Zarin, D. A., Tse, T., Williams, R. J. & Carr, S. Trial reporting in ClinicalTrials.gov - the final rule. N. Engl. J. Med. 375, 1998-2004 (2016).
    • (2016) N. Engl. J. Med. , vol.375 , pp. 1998-2004
    • Zarin, D.A.1    Tse, T.2    Williams, R.J.3    Carr, S.4
  • 106
    • 22144431885 scopus 로고    scopus 로고
    • Contradicted and initially stronger effects in highly cited clinical research
    • Ioannidis, J. P. Contradicted and initially stronger effects in highly cited clinical research. JAMA 294, 218-228 (2005).
    • (2005) JAMA , vol.294 , pp. 218-228
    • Ioannidis, J.P.1
  • 107
    • 84955481124 scopus 로고    scopus 로고
    • Sharing clinical trial data - A proposal from the International Committee of Medical Journal Editors
    • Taichman, D. B. et al. Sharing clinical trial data - a proposal from the International Committee of Medical Journal Editors. N. Engl. J. Med. 374, 384-386 (2016).
    • (2016) N. Engl. J. Med. , vol.374 , pp. 384-386
    • Taichman, D.B.1
  • 108
    • 84982129858 scopus 로고    scopus 로고
    • Strengthening research through data sharing
    • Warren, E. Strengthening research through data sharing. N. Engl. J. Med. 375, 401-403 (2016).
    • (2016) N. Engl. J. Med. , vol.375 , pp. 401-403
    • Warren, E.1
  • 109
    • 84982161804 scopus 로고    scopus 로고
    • Ternational Consortium of Investigators for Fairness in Trial Data Sharing. Toward fairness in data sharing
    • International Consortium of Investigators for Fairness in Trial Data Sharing. Toward fairness in data sharing. N. Engl. J. Med. 375, 405-407 (2016).
    • (2016) N. Engl. J. Med. , vol.375 , pp. 405-407
  • 110
    • 84982099058 scopus 로고    scopus 로고
    • The yale open data access (YODA) project - A mechanism for data sharing
    • Krumholz, H. M. & Waldstreicher, J. The Yale Open Data Access (YODA) Project - a mechanism for data sharing. N. Engl. J. Med. 375, 403-405 (2016).
    • (2016) N. Engl. J. Med. , vol.375 , pp. 403-405
    • Krumholz, H.M.1    Waldstreicher, J.2


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