Registry-based randomized clinical trials - A new clinical trial paradigm

Nature Reviews Cardiology

Volumn 12, Issue 5, 2015, Pages 312-316

  James, Stefan ^a   Rao, Sunil V ^b   Granger, Christopher B ^b  

^a UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); COST; HEART INFARCTION; HUMAN; MULTICENTER STUDY (TOPIC); OBSERVATIONAL STUDY; OXYGEN THERAPY; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; STUDY DESIGN; CARDIOLOGY; METHODOLOGY;

CARDIOLOGY; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; RESEARCH DESIGN;

EID: 84928585961     PISSN: 17595002     EISSN: 17595010     Source Type: Journal    
DOI: 10.1038/nrcardio.2015.33     Document Type: Article

References (29)

1. Steg, P. G., James, S. K. & Gersh, B. J. 2012 ESC STEMI guidelines and reperfusion therapy: evidence-based recommendations, ensuring optimal patient management. Heart 99, 1156-1157 (2013).
2. O'Gara, P. T. et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 127, e362-e425 (2013).
3. Tricoci, P., Allen, J. M., Kramer, J. M., Califf, R. M. & Smith, S. C. Jr. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA 301, 831-841 (2009).
4. Wiviott, S. D. et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N. Eng. J. Med. 357, 2001-2015 (2007).
5. Carlsson, J. et al. Outcome of drug-eluting versus bare-metal stenting used according to on-and off-label criteria. J. Am. Coll. Cardiol. 53, 1389-1398 (2009).
6. Reith, C. et al. Randomized clinical trials-removing unnecessary obstacles. N. Eng. J. Med. 369, 1061-1065 (2013).
7. Duley, L. et al. Specific barriers to the conduct of randomized trials. Clin. Trials 5, 40-48 (2008).
8. 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).
9. Jernberg, T. et al. The Swedish web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART). Heart 96, 1617-1621 (2010).
10. James, S. K. et al. Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden. N. Eng. J. Med. 360, 1933-1945 (2009).
11. Lagerqvist, B. et al. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N. Eng. J. Med. 356, 1009-1019 (2007).
12. Bondesson, P. et al. Comparison of two drug-eluting balloons: a report from the SCAAR registry. EuroIntervention 8, 444-449 (2012).
13. Graham, D. J. et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for non-valvular atrial fibrillation. Circulation 131, 157-164 (2015).
14. Benson, K. & Hartz, A. J. A comparison of observational studies and randomized, controlled trials. N. Eng. J. Med. 342, 1878-1886 (2000).
15. James, S., Frobert, O. & Lagerqvist, B. Cardiovascular registries: a novel platform for randomised clinical trials. Heart 98, 1329-1331 (2012).
16. Lauer, M. S. & D'Agostino, R. B. Sr. The randomized registry trial-the next disruptive technology in clinical research? N. Eng. J. Med. 369, 1579-1581 (2013).
17. Fröbert, 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).
18. Lagerqvist, B. et al. Outcomes 1 year after thrombus aspiration for myocardial infarction. N. Eng. J. Med. 371, 1111-1120 (2014).
19. Harnek, J. et al. The 2011 outcome from the Swedish Health Care Registry on Heart Disease (SWEDEHEART). Scand. Cardiovas. J. 47 (Suppl.), 1-10 (2013).
20. Fröbert, O. et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N. Eng. J. Med. 369, 1587-1597 (2013).
21. Thuesen, L. et al. Event detection using population-based health care databases in randomized clinical trials: a novel research tool in interventional cardiology. Clin. Epidemiol. 19, 357-361 (2013).
22. Devereaux, P. J. & Yusuf, S. When it comes to trials, do we get what we pay for? N. Eng. J. Med. 369, 1962-1963 (2013).
23. Thuesen, L. et al. Event detection using population-based health care databases in randomized clinical trials: a novel research tool in interventional cardiology. Clin. Epidemiol. 5, 357-361 (2013).
24. Moussa, I. et al. The NCDR CathPCI Registry: a US national perspective on care and outcomes for percutaneous coronary intervention. Heart 99, 297-303 (2013).
25. Hess, C. N. et al. Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women). Am.Heart J. 166, 421-428 (2013).
26. Hofmann, R. et al. DETermination of the role of Oxygen in suspected Acute Myocardial Infarction trial. Am. Heart J. 167, 322-328 (2014).
27. Swedish Population Registry. Swedish Tax Agency [online], http://www.skatteverket.se (2015).
28. US National Library of Medicine. ClinicalTrials.gov [online], https://clinicaltrials.gov/ct2/show/NCT02311231 (2015).
29. Patient-Centered Outcomes Research Institute. Research We Support [online], http://www.pcori.org/content/research-we-support (2014).