메뉴 건너뛰기




Volumn 91, Issue 3, 2016, Pages 305-309

Recommendations to facilitate expanded access to investigational therapies for seriously ill patients

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

EID: 84958899259     PISSN: 10402446     EISSN: 1938808X     Source Type: Journal    
DOI: 10.1097/ACM.0000000000000914     Document Type: Review
Times cited : (15)

References (34)
  • 1
    • 84955325042 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration Accessed July 9 2015
    • U.S. Food and Drug Administration. Expanded access: Information for patients. http://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm. Accessed July 9, 2015.
    • Expanded Access: Information for Patients
  • 2
    • 84958830838 scopus 로고    scopus 로고
    • Code of Federal Regulations, Title 21. U.S. Food and Drug Administration Final rule. 21 C.F.R. §§ 312 316
    • Code of Federal Regulations, Title 21. U.S. Food and Drug Administration. Expanded access to investigational drugs for treatment use. Final rule. 21 C.F.R. §§312, 316 (2009).
    • (2009) Expanded Access to Investigational Drugs for Treatment Use
  • 5
    • 84958942131 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration Accessed July 10 2015
    • U.S. Food and Drug Administration. Expanded access INDs and protocols: Expanded access submission receipts reports, 2010-2014. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/INDActivityReports/ucm373560.htm. Accessed July 10, 2015.
    • Expanded Access INDs and Protocols: Expanded Access Submission Receipts Reports, 2010-2014
  • 6
    • 84903782231 scopus 로고    scopus 로고
    • Food and Drug Administration responds to pressure for expanded drug access
    • Brower V. Food and Drug Administration responds to pressure for expanded drug access. J Natl Cancer Inst. 2014;106:dju171.
    • (2014) J Natl Cancer Inst , vol.106 , pp. dju171
    • Brower, V.1
  • 7
    • 70349928587 scopus 로고    scopus 로고
    • Expanded access rules pose quandary for drug developers
    • Mack GS. Expanded access rules pose quandary for drug developers. Nat Biotechnol. 2009;27:871-872.
    • (2009) Nat Biotechnol , vol.27 , pp. 871-872
    • Mack, G.S.1
  • 8
    • 33846141187 scopus 로고    scopus 로고
    • A new era of unapproved drugs: The case of Abigail Alliance v von Eschenbach
    • Jacobson PD, Parmet WE. A new era of unapproved drugs: The case of Abigail Alliance v Von Eschenbach. JAMA. 2007;297:205-208.
    • (2007) JAMA , vol.297 , pp. 205-208
    • Jacobson, P.D.1    Parmet, W.E.2
  • 9
    • 34249025499 scopus 로고    scopus 로고
    • Food and Drug Administration expanded access to treatment: Implications for oncology patients
    • Freedman RS, Markman M. Food and Drug Administration expanded access to treatment: Implications for oncology patients. Cancer. 2007;109:2157-2160.
    • (2007) Cancer , vol.109 , pp. 2157-2160
    • Freedman, R.S.1    Markman, M.2
  • 10
    • 84958831562 scopus 로고    scopus 로고
    • Dying patients denied drugs
    • April 6 Accessed July 10 2015
    • Cohen E. Dying patients denied drugs. CNN. April 6, 2014. http://edition. cnn.com/2014/04/05/health/cohencompassionate-use/. Accessed July 10, 2015.
    • (2014) CNN
    • Cohen, E.1
  • 11
    • 84924953484 scopus 로고    scopus 로고
    • Ethical considerations of experimental interventions in the Ebola outbreak
    • Rid A, Emanuel EJ. Ethical considerations of experimental interventions in the Ebola outbreak. Lancet. 2014;384:1896-1899.
    • (2014) Lancet , vol.384 , pp. 1896-1899
    • Rid, A.1    Emanuel, E.J.2
  • 12
    • 84958883356 scopus 로고    scopus 로고
    • Biotechnology Industry Organization (BIO) March 18 Accessed July 10 2015
    • Biotechnology Industry Organization (BIO). BIO statement on compassionate use. March 18, 2014. https://www.bio.org/articles/biostatement-compassionate-use. Accessed July 10, 2015.
    • (2014) BIO Statement on Compassionate Use
  • 16
    • 84924923500 scopus 로고    scopus 로고
    • The strange allure of state right-to-try laws
    • Zettler PJ, Greely HT. The strange allure of state "right-to-try" laws. JAMA Intern Med. 2014;174:1885-1886.
    • (2014) JAMA Intern Med , vol.174 , pp. 1885-1886
    • Zettler, P.J.1    Greely, H.T.2
  • 17
    • 67649413537 scopus 로고    scopus 로고
    • Expanding access to investigational drugs for treatment use: A policy analysis and legislative proposal
    • Winniford A. Expanding access to investigational drugs for treatment use: A policy analysis and legislative proposal. Health Matrix Clevel. 2009;19:205-246.
    • (2009) Health Matrix Clevel , vol.19 , pp. 205-246
    • Winniford, A.1
  • 18
    • 84958838506 scopus 로고    scopus 로고
    • Accessed July 16, 2015.
    • 21st Century Cures Act, H.R. 6, 114th Cong (2015). https://www.congress.gov/bill/114thcongress/house-bill/6. Accessed July 16, 2015.
    • (2015) 21st Century Cures Act, H.R. 6, 114th Cong
  • 19
    • 84958941704 scopus 로고    scopus 로고
    • Accessed July 16 2015
    • Right to Try Act of 2015, H.R. 3012, 114th Cong (2015). https://www.congress.gov/bill/114th-congress/house-bill/3012. Accessed July 16, 2015.
    • (2015) Right to Try Act of 2015 H.R.3012, 114th Cong
  • 21
    • 84893244813 scopus 로고    scopus 로고
    • What proportion of chronic obstructive pulmonary disease outpatients is eligible for inclusion in randomized clinical trials?
    • Scichilone N, Basile M, Battaglia S, Bellia V. What proportion of chronic obstructive pulmonary disease outpatients is eligible for inclusion in randomized clinical trials? Respiration. 2014;87:11-17.
    • (2014) Respiration , vol.87 , pp. 11-17
    • Scichilone, N.1    Basile, M.2    Battaglia, S.3    Bellia, V.4
  • 22
    • 0035869003 scopus 로고    scopus 로고
    • Prospective evaluation of cancer clinical trial accrual patterns: Identifying potential barriers to enrollment
    • Lara PN Jr, Higdon R, Lim N, et al. Prospective evaluation of cancer clinical trial accrual patterns: Identifying potential barriers to enrollment. J Clin Oncol. 2001;19:1728-1733.
    • (2001) J Clin Oncol , vol.19 , pp. 1728-1733
    • Lara, Jr.P.N.1    Higdon, R.2    Lim, N.3
  • 23
    • 84860462185 scopus 로고    scopus 로고
    • The eligibility of advanced non-small-cell lung cancer patients for targeted therapy clinical trials
    • Clarey J, Kao SC, Clarke SJ, Vardy J. The eligibility of advanced non-small-cell lung cancer patients for targeted therapy clinical trials. Ann Oncol. 2012;23:1229-1233.
    • (2012) Ann Oncol , vol.23 , pp. 1229-1233
    • Clarey, J.1    Kao, S.C.2    Clarke, S.J.3    Vardy, J.4
  • 24
    • 84958871060 scopus 로고    scopus 로고
    • Prescription Drug User Fee Act patientfocused drug development: Request for comments
    • U.S. Food Drug Administration.
    • U.S. Food and Drug Administration. Prescription Drug User Fee Act patientfocused drug development: Request for comments. Fed Reg. 2014;29:60857-60859.
    • (2014) Fed Reg , vol.29 , pp. 60857-60859
  • 25
    • 84870706167 scopus 로고    scopus 로고
    • Patterns of response in patients with pretreated metastatic melanoma who received ipilimumab 3 mg/kg in a European expanded access program: Five illustrative case reports
    • Wilgenhof S, Du Four S, Everaert H, Neyns B. Patterns of response in patients with pretreated metastatic melanoma who received ipilimumab 3 mg/kg in a European expanded access program: Five illustrative case reports. Cancer Invest. 2012;30:712-720.
    • (2012) Cancer Invest , vol.30 , pp. 712-720
    • Wilgenhof, S.1    Du Four, S.2    Everaert, H.3    Neyns, B.4
  • 26
    • 84948711592 scopus 로고    scopus 로고
    • Treatment of two patients with generalized pustular psoriasis with the interleukin-1? Inhibitor gevokizumab
    • Mansouri B, Richards L, Menter A. Treatment of two patients with generalized pustular psoriasis with the interleukin-1? inhibitor gevokizumab. Br J Dermatol. 2015;173:239-241.
    • (2015) Br J Dermatol , vol.173 , pp. 239-241
    • Mansouri, B.1    Richards, L.2    Menter, A.3
  • 27
    • 84958860177 scopus 로고    scopus 로고
    • J&J changes 'compassionate' care-independent panel to review requests from seriously ill patients for unapproved medicine
    • May
    • Rockoff JD. J&J changes 'compassionate' care-independent panel to review requests from seriously ill patients for unapproved medicine. Wall Str J (East ed). May 7, 2015:B1.
    • (2015) Wall Str J (East Ed) , vol.7 , pp. B1
    • Rockoff, J.D.1
  • 28
    • 84859871576 scopus 로고    scopus 로고
    • Preparedness of the CTSA's structural and scientific assets to support the mission of the National Center for Advancing Translational Sciences (NCATS)
    • Bernard GR. Preparedness of the CTSA's structural and scientific assets to support the mission of the National Center for Advancing Translational Sciences (NCATS). Clin Transl Sci. 2012;5:121-129.
    • (2012) Clin Transl Sci , vol.5 , pp. 121-129
    • Bernard, G.R.1
  • 29
    • 84873849027 scopus 로고    scopus 로고
    • Using central IRBs for multicenter clinical trials in the United States
    • Flynn KE, Hahn CL, Kramer JM, et al. Using central IRBs for multicenter clinical trials in the United States. PLoS One. 2013;8:e54999.
    • (2013) PLoS One , vol.8 , pp. e54999
    • Flynn, K.E.1    Hahn, C.L.2    Kramer, J.M.3
  • 30
    • 84958887768 scopus 로고    scopus 로고
    • Accessed July 10 2015
    • IRBshare. http://irbshare.org/. Accessed July 10, 2015.
    • IRBshare
  • 31
    • 84958947974 scopus 로고    scopus 로고
    • Internal Revenue Service Revised March Accessed July 10 2015
    • Internal Revenue Service. Corporations (publication 542). Revised March 2012. http://www.irs.gov/publications/p542/index. html. Accessed July 10, 2015.
    • (2012) Corporations (Publication 542)
  • 33
    • 84958897578 scopus 로고    scopus 로고
    • August 26 Accessed July 10 2015
    • Yao L. FDA takes step to encourage pediatric drug studies. August 26, 2013. http://blogs. fda.gov/fdavoice/index.php/2013/08/fdatakes-step-to-encourage-pediatric-drugstudies/. Accessed July 10, 2015.
    • (2013) FDA Takes Step to Encourage Pediatric Drug Studies
    • Yao, L.1
  • 34
    • 0030990804 scopus 로고    scopus 로고
    • Learning from our patients: One participant's impact on clinical trial research and informed consent
    • Daugherty CK, Siegler M, Ratain MJ, Zimmer G. Learning from our patients: One participant's impact on clinical trial research and informed consent. Ann Intern Med. 1997;126:892-897.
    • (1997) Ann Intern Med , vol.126 , pp. 892-897
    • Daugherty, C.K.1    Siegler, M.2    Ratain, M.J.3    Zimmer, G.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.