Regulatory science: Trust and transparency in clinical trials of medical devices

Nature Reviews Cardiology

Volumn 12, Issue 9, 2015, Pages 503-504

  Kramer, Daniel B ^a   Cutlip, Donald E ^a  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARDIOVASCULAR DEVICE; CLINICAL STUDY; CLINICAL TRIAL (TOPIC); HUMAN; MEDICAL DEVICE; MEDICAL LITERATURE; PEER REVIEW; PRIORITY JOURNAL; PUBLICATION; SHORT SURVEY; DEVICE APPROVAL; HEART ASSIST DEVICE;

DEVICE APPROVAL; HEART-ASSIST DEVICES; HUMANS;

EID: 84939772613     PISSN: 17595002     EISSN: 17595010     Source Type: Journal    
DOI: 10.1038/nrcardio.2015.112     Document Type: Short Survey

References (8)

1. Kramer, D. B., Xu, S. & Kesselheim, A. S. Regulation of medical devices in the United States and European Union. N. Engl. J. Med. 366, 848-855 (2012).
2. U.S. Department of Health and Human Services. U.S. Food and Drug Administration. Premarket Approval (PMA) [online], http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/ (2014).
3. Chang, L., Dhruva, S. S., Chu, J., Bero, L. A. & Redberg, R. F. Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports. BMJ 350, h2613 (2015).
4. U.S. Department of Health and Human Services. U.S. Food and Drug Administration. Premarket Approval (PMA) Database [online], http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm (2015).
5. Kramer, D. B., Mallis, E., Zuckerman, B. D., Zimmerman, B. A. & Maisel, W. H. Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007. Am. J. Ther. 17, 2-7 (2010).
6. Anderson, M. L. et al. Compliance with results reporting at ClinicalTrials.gov. N. Engl. J. Med. 372, 1031-1039 (2015).
7. Kesselheim, A. S. et al. A randomized study of how physicians interpret research funding disclosures. N. Engl. J. Med. 367, 1119-1127 (2012).
8. 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).