메뉴 건너뛰기




Volumn 96, Issue 3, 2018, Pages 499-529

Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?

Author keywords

clinical trials; device approval; diversity; subgroup analysis; US Food and Drug Administration (FDA)

Indexed keywords

AGE; ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); DEVICE APPROVAL; DEVICE SAFETY; GENDER; HUMAN; PATIENT CARE; PRIORITY JOURNAL; RACE; ADOLESCENT; ADULT; AGED; ANCESTRY GROUP; FEMALE; LEGISLATION AND JURISPRUDENCE; MALE; MIDDLE AGED; MINORITY GROUP; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEX FACTOR; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

EID: 85053052053     PISSN: 0887378X     EISSN: 14680009     Source Type: Journal    
DOI: 10.1111/1468-0009.12344     Document Type: Article
Times cited : (17)

References (58)
  • 1
    • 84874042177 scopus 로고    scopus 로고
    • Racial differences in long-term outcomes after percutaneous coronary intervention with paclitaxel-eluting coronary stents
    • Batchelor WB, Ellis SG, Ormiston JA, et al. Racial differences in long-term outcomes after percutaneous coronary intervention with paclitaxel-eluting coronary stents. J Interv Cardiol. 2013;26(1):49-57. https://doi.org/10.1111/j.1540-8183.2012.00760.x
    • (2013) J Interv Cardiol , vol.26 , Issue.1 , pp. 49-57
    • Batchelor, W.B.1    Ellis, S.G.2    Ormiston, J.A.3
  • 2
    • 84875770850 scopus 로고    scopus 로고
    • Sex and risk of hip implant failure
    • Inacio MCS, Ake CF, Paxton EW, et al. Sex and risk of hip implant failure. JAMA Intern Med. 2013;173(6):435. https://doi.org/10.1001/jamainternmed.2013.3271
    • (2013) JAMA Intern Med , vol.173 , Issue.6 , pp. 435
    • Inacio, M.C.S.1    Ake, C.F.2    Paxton, E.W.3
  • 3
    • 84878858136 scopus 로고    scopus 로고
    • The relationship of age, race, and ethnicity with survival in dialysis patients
    • Yan G, Norris KC, Yu AJ, et al. The relationship of age, race, and ethnicity with survival in dialysis patients. Clin J Am Soc Nephrol. 2013;8(6):953-961. https://doi.org/10.2215/CJN.09180912
    • (2013) Clin J Am Soc Nephrol , vol.8 , Issue.6 , pp. 953-961
    • Yan, G.1    Norris, K.C.2    Yu, A.J.3
  • 4
    • 85053057117 scopus 로고    scopus 로고
    • Accessed July 30, 2018.
    • National Institutes of Health Revitalization Act, Pub L No. 103–43, 107 Stat 102 (1993). https://www.gpo.gov/fdsys/pkg/STATUTE-107/pdf/STATUTE-107-Pg122.pdf. Accessed July 30, 2018
    • Pub L No. 103–43, 107 Stat 102 , Issue.1993
  • 5
    • 85053025776 scopus 로고    scopus 로고
    • Washington, DC, Department of Health and Human Services, October 24,, Accessed June 18, 2018.
    • US Department of Health & Human Services. Policy Statement on Inclusion of Race and Ethnicity in DHHS Data Collection Activities. Washington, DC: Department of Health and Human Services; October 24, 1997. https://aspe.hhs.gov/policy-statement-inclusion-race-and-ethnicity-dhhs-data-collection-activities. Accessed June 18, 2018
    • (1997) Policy Statement on Inclusion of Race and Ethnicity in DHHS Data Collection Activities
  • 7
    • 85053038217 scopus 로고
    • Silver Spring, MD, US Food and Drug Administration
    • US Food and Drug Administration Office of Device Evaluation. Annual Report Fiscal Year 1994. Silver Spring, MD: US Food and Drug Administration; 1995
    • (1995) Annual Report Fiscal Year 1994
  • 8
    • 85018373165 scopus 로고    scopus 로고
    • Silver Spring, MD, US Food and Drug Administration, Accessed June 18, 2018.
    • US Food and Drug Administration. Guidance for Industry: E7 Studies in Support of Special Populations; Geriatrics Questions and Answers. Silver Spring, MD: US Food and Drug Administration; 2012. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm189544.pdf. Accessed June 18, 2018
    • (2012) Guidance for Industry: E7 Studies in Support of Special Populations; Geriatrics Questions and Answers
  • 11
    • 85053038268 scopus 로고    scopus 로고
    • Gender bias in studies for FDA premarket approval of cardiovascular devices
    • Dhruva SS, Cullen EB, Redberg RF. Gender bias in studies for FDA premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes. 2011;4:165-171. https://doi.org/10.1007/s12170-014-0389-2
    • (2011) Circ Cardiovasc Qual Outcomes , vol.4 , pp. 165-171
    • Dhruva, S.S.1    Cullen, E.B.2    Redberg, R.F.3
  • 12
    • 76149099323 scopus 로고    scopus 로고
    • Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000–2007
    • Kramer DB, Mallis E, Zuckerman BD, Zimmerman BA, Maisel WH. 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. 2010;17(1):2-7. https://doi.org/10.1097/MJT.0b013e3181ca8105
    • (2010) Am J Ther , vol.17 , Issue.1 , pp. 2-7
    • Kramer, D.B.1    Mallis, E.2    Zuckerman, B.D.3    Zimmerman, B.A.4    Maisel, W.H.5
  • 13
    • 85053030152 scopus 로고    scopus 로고
    • Pub L 112–144, 126 Stat 993., Accessed July 30, 2018.
    • Food and Drug Administration Safety and Innovation Act, Pub L No. 112–144, 126 Stat 993 (2012). https://www.congress.gov/112/plaws/publ144/PLAW-112publ144.pdf. Accessed July 30, 2018
    • Food and Drug Administration Safety and Innovation Act , Issue.2012
  • 19
    • 84873066567 scopus 로고    scopus 로고
    • Published 2018. Accessed May 24, 2018.
    • PMA application contents. US Food and Drug Administration website. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050289.htm. Published 2018. Accessed May 24, 2018
    • US Food and Drug Administration website
  • 20
    • 36348939350 scopus 로고    scopus 로고
    • Statistics in medicine: reporting of subgroup analyses in clinical trials
    • Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine: reporting of subgroup analyses in clinical trials. N Engl J Med. 2007;357(21):2189-2194. https://doi.org/10.1056/NEJMsr077003
    • (2007) N Engl J Med , vol.357 , Issue.21 , pp. 2189-2194
    • Wang, R.1    Lagakos, S.W.2    Ware, J.H.3    Hunter, D.J.4    Drazen, J.M.5
  • 21
    • 84873066567 scopus 로고    scopus 로고
    • Published 2018. Accessed May 24, 2018.
    • Premarket approval (PMA) database. US Food and Drug Administration website. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Published 2018. Accessed May 24, 2018
    • US Food and Drug Administration website
  • 22
    • 85053033508 scopus 로고    scopus 로고
    • Silver Spring, MD, US Food and Drug Administration, Accessed June 12, 2018.
    • United States Food and Drug Administration. FDA Executive Summary: STAAR Surgical Visian Toric Implantable Collamer® Lens. Silver Spring, MD: US Food and Drug Administration; 2014. https://wayback.archive-it.org/7993/20170114045346/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OphthalmicDevicesPanel/UCM385479.pdf. Accessed June 12, 2018
    • (2014) FDA Executive Summary: STAAR Surgical Visian Toric Implantable Collamer® Lens
  • 23
    • 84995585606 scopus 로고    scopus 로고
    • Irvine, CA AcuFocus Inc; 2015., Accessed June 12, 2018.
    • KAMRA Inlay: Professional Use Information. Irvine, CA: AcuFocus Inc; 2015. https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120023D.pdf. Accessed June 12, 2018
    • KAMRA Inlay: Professional Use Information
  • 24
    • 85053043359 scopus 로고    scopus 로고
    • Plymouth, MN St. Jude Medical; 2016., Accessed June 12, 2018.
    • AMPLATZER PFO Occluder: Instructions for Use. Plymouth, MN: St. Jude Medical; 2016. https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120021C.pdf. Accessed June 12, 2018
    • AMPLATZER PFO Occluder: Instructions for Use
  • 25
    • 85053041838 scopus 로고    scopus 로고
    • Silver Spring, MD, US Food and Drug Administration, Accessed June 12, 2018.
    • US Food and Drug Administration. FDA Executive Summary: Bard LUTONIX 035 Drug Coated Balloon PTA Catheter. Silver Spring, MD: US Food and Drug Administration; 2014. http://wayback.archive-it.org/7993/20170114045515/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM400614.pdf. Accessed June 12, 2018
    • (2014) FDA Executive Summary: Bard LUTONIX 035 Drug Coated Balloon PTA Catheter
  • 26
    • 85053048474 scopus 로고    scopus 로고
    • New Hope, MN, Bard Lutonix, Accessed June 12, 2018.
    • Bard Lutonix Inc. Sponsor Executive Summary: Lutonix Drug Coated Balloon PTA Catheter. New Hope, MN: Bard Lutonix; 2014. http://wayback.archive-it.org/7993/20170114045522/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM400420.pdf. Accessed June 12, 2018
    • (2014) Sponsor Executive Summary: Lutonix Drug Coated Balloon PTA Catheter
  • 27
    • 85053057793 scopus 로고    scopus 로고
    • Silver Spring, MD, US Food and Drug Administration, Accessed June 12, 2018.
    • US Food and Drug Administration. FDA Executive Summary: Cologuard. Silver Spring, MD: US Food and Drug Administration; 2014. http://wayback.archive-it.org/7993/20170114045719/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM390220.pdf. Accessed June 12, 2018
    • (2014) FDA Executive Summary: Cologuard
  • 28
    • 85053030060 scopus 로고    scopus 로고
    • Madison, WI, Exact Sciences Corporation, Accessed June 18, 2018.
    • TM SDNA-Based Colorectal Cancer Screening Test. Madison, WI: Exact Sciences Corporation; 2014. http://wayback.archive-it.org/7993/20170114045736/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM390227.pdf. Accessed June 18, 2018
    • (2014) TM SDNA-Based Colorectal Cancer Screening Test
  • 29
    • 85053072060 scopus 로고    scopus 로고
    • Silver Spring, MD, US Food and Drug Administration, Accessed June 18, 2018.
    • US Food and Drug Administration. FDA Executive Summary: Epi ProColon®. Silver Spring, MD: US Food and Drug Administration; 2014. http://wayback.archive-it.org/7993/20170114045715/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM390221.pdf. Accessed June 18, 2018
    • (2014) FDA Executive Summary: Epi ProColon®
  • 30
    • 85053055663 scopus 로고    scopus 로고
    • Berlin, Germany, Epigenomics AG, Accessed June 12, 2018.
    • Epigenomics AG. Sponsor Executive Summary: Epi ProColon® Test. Berlin, Germany: Epigenomics AG; 2014. http://wayback.archive-it.org/7993/20170114045728/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM390234.pdf. Accessed June 12, 2018
    • (2014) Sponsor Executive Summary: Epi ProColon® Test
    • Epigenomics, A.G.1
  • 31
    • 85053026850 scopus 로고    scopus 로고
    • Silver Spring, MD, US Food and Drug Administration, Accessed June 18, 2018.
    • US Food and Drug Administration. FDA Executive Summary: KAMRA Corneal Inlay, Model ACI 7000. Silver Spring, MD: US Food and Drug Administration; 2014. http://wayback.archive-it.org/7993/20170114045310/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OphthalmicDevicesPanel/UCM399638.pdf. Accessed June 18, 2018
    • (2014) FDA Executive Summary: KAMRA Corneal Inlay, Model ACI 7000
  • 32
    • 85053058212 scopus 로고    scopus 로고
    • Irvine, CA, AcuFocus Inc
    • TM Inlay—Model ACI 7000. Irvine, CA: AcuFocus Inc; 2014
    • (2014) TM Inlay—Model ACI 7000
  • 33
    • 84870532305 scopus 로고    scopus 로고
    • Variation in corneal hysteresis and central corneal thickness among black, hispanic and white subjects
    • Haseltine SJ, Pae J, Ehrlich JR, Shammas M, Radcliffe NM. Variation in corneal hysteresis and central corneal thickness among black, hispanic and white subjects. Acta Ophthalmol. 2012;90(8):626-631. https://doi.org/10.1111/j.1755-3768.2012.02509.x
    • (2012) Acta Ophthalmol , vol.90 , Issue.8 , pp. 626-631
    • Haseltine, S.J.1    Pae, J.2    Ehrlich, J.R.3    Shammas, M.4    Radcliffe, N.M.5
  • 34
    • 0141682012 scopus 로고    scopus 로고
    • Intraocular pressure, Goldmann applanation tension, corneal thickness, and corneal curvature in Caucasians, Asians, Hispanics, and African Americans
    • Shimmyo M, Ross AJ, Moy A, Mostafavi R. Intraocular pressure, Goldmann applanation tension, corneal thickness, and corneal curvature in Caucasians, Asians, Hispanics, and African Americans. Am J Ophthalmol. 2003;136(4):603-613. https://doi.org/10.1016/S0002-9394(03)00424-0
    • (2003) Am J Ophthalmol , vol.136 , Issue.4 , pp. 603-613
    • Shimmyo, M.1    Ross, A.J.2    Moy, A.3    Mostafavi, R.4
  • 35
    • 0028393608 scopus 로고
    • Women and health research: a report from the Institute of Medicine
    • Mastroianni AC, Faden R, Federman D. Women and health research: a report from the Institute of Medicine. Kennedy Inst Ethics J. 1994;4(1):55-62
    • (1994) Kennedy Inst Ethics J , vol.4 , Issue.1 , pp. 55-62
    • Mastroianni, A.C.1    Faden, R.2    Federman, D.3
  • 36
    • 33947498821 scopus 로고    scopus 로고
    • Eligibility criteria of randomized controlled trials published in high-impact general medical journals
    • Van Spall HGC, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals. JAMA. 2007;297(11):1233. https://doi.org/10.1001/jama.297.11.1233
    • (2007) JAMA , vol.297 , Issue.11 , pp. 1233
    • Van Spall, H.G.C.1    Toren, A.2    Kiss, A.3    Fowler, R.A.4
  • 37
    • 84963502461 scopus 로고    scopus 로고
    • Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals
    • Downing NS, Shah ND, Neiman JH, Aminawung JA, Krumholz HM, Ross JS. Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals. Trials. 2016;17(1). https://doi.org/10.1186/s13063-016-1322-4
    • (2016) Trials , vol.17 , Issue.1
    • Downing, N.S.1    Shah, N.D.2    Neiman, J.H.3    Aminawung, J.A.4    Krumholz, H.M.5    Ross, J.S.6
  • 38
    • 84947077364 scopus 로고    scopus 로고
    • Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA from 2010 to 2012
    • Eshera N, Itana H, Zhang L, Soon G, Fadiran EO. Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA from 2010 to 2012. Am J Ther. 2015;22(6):435-455. https://doi.org/10.1097/MJT.0000000000000177
    • (2015) Am J Ther , vol.22 , Issue.6 , pp. 435-455
    • Eshera, N.1    Itana, H.2    Zhang, L.3    Soon, G.4    Fadiran, E.O.5
  • 40
    • 85029052676 scopus 로고    scopus 로고
    • Inclusion of demographic-specific information in studies supporting US Food and Drug Administration approval of high-risk medical devices
    • Dhruva SS, Mazure CM, Ross JS, Redberg RF. Inclusion of demographic-specific information in studies supporting US Food and Drug Administration approval of high-risk medical devices. JAMA Intern Med. 2017;177(9):1390. https://doi.org/10.1001/jamainternmed.2017.3148
    • (2017) JAMA Intern Med , vol.177 , Issue.9 , pp. 1390
    • Dhruva, S.S.1    Mazure, C.M.2    Ross, J.S.3    Redberg, R.F.4
  • 41
    • 84937415685 scopus 로고    scopus 로고
    • Silver Spring, MD, US Food and Drug Administration, Accessed June 18, 2018
    • US Food and Drug Administration. FDA Report: FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data. Silver Spring, MD: US Food and Drug Administration; 2014. http://www.fda.gov/downloads/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/UCM410474.pdf. Accessed June 18, 2018
    • (2014) FDA Report: FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data
  • 43
    • 85053043074 scopus 로고    scopus 로고
    • US Food and Drug Administration website., Published March 2018. Accessed May 24, 2018.
    • FDA's action plan for FDASIA Section 907: questions and answers. US Food and Drug Administration website. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm410382.htm. Published March 2018. Accessed May 24, 2018
    • FDA's action plan for FDASIA Section 907: questions and answers
  • 44
    • 39049126446 scopus 로고    scopus 로고
    • The epidemiology of adult obstructive sleep apnea
    • Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008;5(2):136-143. https://doi.org/10.1513/pats.200709-155MG
    • (2008) Proc Am Thorac Soc , vol.5 , Issue.2 , pp. 136-143
    • Punjabi, N.M.1
  • 45
    • 57749110828 scopus 로고    scopus 로고
    • Epidemiology, risk factors, and consequences of obstructive sleep apnea and short sleep duration
    • Al Lawati NM, Patel SR, Ayas NT. Epidemiology, risk factors, and consequences of obstructive sleep apnea and short sleep duration. Prog Cardiovasc Dis. 2009;51(4):285-293. https://doi.org/10.1016/j.pcad.2008.08.001
    • (2009) Prog Cardiovasc Dis , vol.51 , Issue.4 , pp. 285-293
    • Al Lawati, N.M.1    Patel, S.R.2    Ayas, N.T.3
  • 46
    • 85053070287 scopus 로고    scopus 로고
    • 2014., Accessed June 20, 2018.
    • US Food and Drug Administration. Inspire Upper Airway Stimulation (UAS) System: Executive Summary. 2014. https://wayback.archive-it.org/7993/20170114045750/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/AnesthesiologyandRespiratoryTherapyDevicesPanel/UCM386160.pdf. Accessed June 20, 2018
    • Inspire Upper Airway Stimulation (UAS) System: Executive Summary
  • 47
    • 85053051578 scopus 로고    scopus 로고
    • Maple Grove, MN Inspire Medical Systems Inc; 2014., Accessed June 20, 2018.
    • Inspire Medical Systems Inc. Sponsor Executive Summary: Inspire Upper Airway Stimulation (UAS) System. Maple Grove, MN: Inspire Medical Systems Inc; 2014. https://wayback.archive-it.org/7993/20170114045755/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/AnesthesiologyandRespiratoryTherapyDevicesPanel/UCM386164.pdf. Accessed June 20, 2018
    • Sponsor Executive Summary: Inspire Upper Airway Stimulation (UAS) System
  • 48
    • 85053026366 scopus 로고    scopus 로고
    • Maple Grove, MN, Inspire Medical Systems, Accessed June 12, 2018.
    • Inspire Upper Airway Stimulation (UAS): System Implant Manual. Maple Grove, MN: Inspire Medical Systems; 2014. http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130008D.pdf. Accessed June 12, 2018
    • (2014) Inspire Upper Airway Stimulation (UAS): System Implant Manual
  • 49
    • 85053073105 scopus 로고    scopus 로고
    • Circulatory System Devices Panel, June 12, 2014 [transcript]., Accessed June 12, 2018.
    • US Food and Drug Administration; Center for Devices and Radiological Health; Medical Devices Advisory Committee. Circulatory System Devices Panel, June 12, 2014 [transcript]. http://wayback.archive-it.org/7993/20170114045519/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM404388.pdf. Accessed June 12, 2018
    • US Food and Drug Administration; Center for Devices and Radiological Health; Medical Devices Advisory Committee
  • 51
    • 85053073105 scopus 로고    scopus 로고
    • Molecular and Clinical Genetics Panel, March 26, 2014 [transcript]., Accessed June 12, 2018.
    • US Food and Drug Administration; Center for Devices and Radiological Health; Medical Devices Advisory Committee. Molecular and Clinical Genetics Panel, March 26, 2014 [transcript]. http://wayback.archive-it.org/7993/20170114045726/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM395028.pdf. Accessed June 12, 2018
    • US Food and Drug Administration; Center for Devices and Radiological Health; Medical Devices Advisory Committee
  • 52
    • 85053057942 scopus 로고    scopus 로고
    • Berlin, Germany, Epigenomics AG, Accessed July 20, 2018.
    • Epi proColon® Test [labeling]. Berlin, Germany: Epigenomics AG; 2016. https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130001C.pdf. Accessed July 20, 2018
    • (2016) Epi proColon® Test [labeling]
  • 53
    • 85053055505 scopus 로고    scopus 로고
    • US Food and Drug Administration website., Accessed June 22, 2018.
    • Post-approval studies: Epi proColon. US Food and Drug Administration website. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?c_id=3927&t_id=505162. Accessed June 22, 2018
  • 54
    • 84925282784 scopus 로고    scopus 로고
    • Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices
    • Zuckerman D, Brown P, Das A. Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices. JAMA Intern Med. 2014;174(11):1781-1787. https://doi.org/10.1001/jamainternmed.2014.4193
    • (2014) JAMA Intern Med , vol.174 , Issue.11 , pp. 1781-1787
    • Zuckerman, D.1    Brown, P.2    Das, A.3
  • 56
    • 84939133213 scopus 로고    scopus 로고
    • Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011
    • Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011. JAMA. 2015;314(6):604. https://doi.org/10.1001/jama.2015.8761
    • (2015) JAMA , vol.314 , Issue.6 , pp. 604
    • Rathi, V.K.1    Krumholz, H.M.2    Masoudi, F.A.3    Ross, J.S.4
  • 57
    • 84922732597 scopus 로고    scopus 로고
    • Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies
    • Reynolds IS, Rising JP, Coukell AJ, Paulson KH, Redberg RF. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies. JAMA Intern Med. 2014;174(11):1773-1779. https://doi.org/10.1001/jamainternmed.2014.4194
    • (2014) JAMA Intern Med , vol.174 , Issue.11 , pp. 1773-1779
    • Reynolds, I.S.1    Rising, J.P.2    Coukell, A.J.3    Paulson, K.H.4    Redberg, R.F.5
  • 58


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.