메뉴 건너뛰기




Volumn 42, Issue 2-3, 2016, Pages 429-450

Leveraging novel and existing pathways to approve new therapeutics to treat serious drug-resistant infections

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT;

EID: 84987974464     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/0098858816658275     Document Type: Article
Times cited : (4)

References (66)
  • 1
    • 84900345067 scopus 로고    scopus 로고
    • The perpetual challenge of antimicrobial resistance
    • See Anthony S. Fauci & Hilary D. Marston, The Perpetual Challenge of Antimicrobial Resistance, 311 JAMA 1853, 1853-54 (2014)
    • (2014) JAMA , vol.311 , Issue.1853 , pp. 1853-1854
    • Fauci, A.S.1    Marston, H.D.2
  • 2
    • 84865460977 scopus 로고    scopus 로고
    • Costs of healthcare-and community-associated infections with antimicrobial-resistant versus antimicrobial-susceptible organisms
    • See, e.g., id.; Matthew J. Neidell et al., Costs of Healthcare-and Community-Associated Infections with Antimicrobial-Resistant Versus Antimicrobial-Susceptible Organisms, 55 CLINICAL NFECTIOUS DISEASES 807, 807-15 (2012) (using administrative data to estimate the additional hospital charges associated with healthcare-and community-associated infections ("CAIs") among patients with antimicrobial-resistant versus antimicrobial-susceptible bacterial strains).
    • (2012) Clinical Nfectious Diseases , vol.55 , Issue.807 , pp. 807-815
    • Neidell, M.J.1
  • 3
    • 84863338353 scopus 로고    scopus 로고
    • Show me the money: Long-term financial impact of an antimicrobial stewardship program
    • James Beardsley et al., Show Me the Money: Long-Term Financial Impact of an Antimicrobial Stewardship Program, 33 INFECTION CONTROL & HOSPITAL EPIDEMIOLOGY 398, 398 (2012) (describing the cost savings that could accrue from stewardship)
    • (2012) Infection Control & Hospital Epidemiology , vol.33 , Issue.398 , pp. 398
    • Beardsley, J.1
  • 4
    • 33846153776 scopus 로고    scopus 로고
    • Infectious diseases society of america and the society for healthcare epidemiology of america guidelines for developing an institutional program to enhance antimicrobial stewardship
    • Timothy Dellit et al., Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship, 44 CLINICAL INFECTIOUS DISEASES 159, 160 (2012) (describing recommendations for stewardship in the hospital setting)
    • (2012) Clinical Infectious Diseases , vol.44 , Issue.159 , pp. 160
    • Dellit, T.1
  • 5
    • 84890899357 scopus 로고    scopus 로고
    • Preserving antibiotics rationally
    • Aidan Hollis & Ziana Ahmed, Preserving Antibiotics, Rationally, 369 NEW ENG. J. MED. 2474, 2475 tbl.1 (2013) (describing the widespread use of antibiotics in agricultural practice)
    • (2013) New Eng. J. Med. , vol.369 , Issue.2474 , pp. 2475
    • Hollis, A.1    Ahmed, Z.2
  • 6
    • 84939803933 scopus 로고    scopus 로고
    • Antimicrobial stewardship and public knowledge of antibiotics
    • Thomas J. Hwang et al., Antimicrobial Stewardship and Public Knowledge of Antibiotics, 15 LANCET 1000, 1001 (2015) (describing recent initiatives to improve stewardship of antibiotics in the hospital setting)
    • (2015) LANCET , vol.15 , Issue.1000 , pp. 1001
    • Hwang, T.J.1
  • 7
    • 84901603869 scopus 로고    scopus 로고
    • Target small firms for antibiotic innovation
    • Thomas J. Hwang et al., Target Small Firms for Antibiotic Innovation, 344 SCIENCE 967, 968 (2014) (describing the need for new antimicrobial agents).
    • (2014) Science , vol.344 , Issue.967 , pp. 968
    • Hwang, T.J.1
  • 8
    • 84923894594 scopus 로고    scopus 로고
    • Variations in time of market exclusivity among top-selling prescription drugs in the United States
    • Bo Wang et al., Variations in Time of Market Exclusivity Among Top-Selling Prescription Drugs in the United States, 175 JAMA INTERNAL MED. 635, 635 (2015)
    • (2015) Jama Internal Med. , vol.175 , Issue.635 , pp. 635
    • Wang, B.1
  • 9
    • 70549113620 scopus 로고    scopus 로고
    • U.S. Physician knowledge of the fda-approved indications and evidence base for commonly prescribed drugs: Results of a national survey
    • See Donna T. Chen et al., U.S. Physician Knowledge of the FDA-Approved Indications and Evidence Base for Commonly Prescribed Drugs: Results of a National Survey, 18 PHARMACOEPIDEMIOLOGY & DRUG SAFETY 1094, 1096 (2009) (describing physician attitudes towards the evidence base for new drug approvals)
    • (2009) Pharmacoepidemiology & Drug Safety , vol.18 , Issue.1094 , pp. 1096
    • Chen, D.T.1
  • 10
    • 80052769095 scopus 로고    scopus 로고
    • Communicating uncertainties about prescription drugs to the public
    • Lisa M. Schwartz & Steven Woloshin, Communicating Uncertainties About Prescription Drugs to the Public, 171 ARCHIVES INTERNAL MED. 1463, 1466 (2011) (describing public attitudes towards FDA approval of new drugs).
    • (2011) Archives Internal Med. , vol.171 , Issue.1463 , pp. 1466
    • Schwartz, L.M.1    Woloshin, S.2
  • 11
    • 0028034160 scopus 로고
    • How the pharmaceutical industry brings an antibiotic drug to market in the United States
    • See Stephan A. Billstein, How the Pharmaceutical Industry Brings an Antibiotic Drug to Market in the United States, 38 ANTIMICROBIAL AGENTS & CHEMOTHERAPY 2679, 2679 (1994).
    • (1994) Antimicrobial Agents & Chemotherapy , vol.38 , Issue.2679 , pp. 2679
    • Billstein, S.A.1
  • 12
    • 0032539329 scopus 로고    scopus 로고
    • Understanding controlled trials: Why are randomised controlled trials important?
    • See Bonnie Sibbald & Martin Roland, Understanding Controlled Trials: Why Are Randomised Controlled Trials Important? 316 BRIT. MED. J. 201, 201 (1998) ("Randomised [sic] controlled trials are the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment.")
    • (1998) Brit. Med. J. , vol.316 , Issue.201 , pp. 201
    • Sibbald, B.1    Roland, M.2
  • 13
    • 84890017792 scopus 로고    scopus 로고
    • Differential effectiveness of placebo treatments: A systematic review of migraine prophylaxis
    • Karin Meissner et al., Differential Effectiveness of Placebo Treatments: A Systematic Review of Migraine Prophylaxis, 173 JAMA INTERN MED. 1941, 1942 (2013) (describing the importance of placebo controls when evaluating the effectiveness of medical treatments).
    • (2013) Jama Intern Med. , vol.173 , Issue.1941 , pp. 1942
    • Meissner, K.1
  • 15
    • 77951529251 scopus 로고
    • Streptomycin treatment of pulmonary tuberculosis: A medical research council investigation
    • See Geoffrey Marshall et al., Streptomycin Treatment of Pulmonary Tuberculosis: A Medical Research Council Investigation, 2 BRIT. MED. J. 4582, 4582 (1948) (presenting the results of the first randomized, controlled trial of streptomycin for the treatment of pulmonary tuberculosis).
    • (1948) Brit. Med. J. , vol.2 , Issue.4582 , pp. 4582
    • Marshall, G.1
  • 16
    • 84898605151 scopus 로고    scopus 로고
    • The calculus of cures
    • See Robert Kocher & Bryan Roberts, The Calculus of Cures, 370 NEW ENG. J. MED. 1473, 1474 (2014)
    • (2014) New Eng. J. Med. , vol.370 , Issue.1473 , pp. 1474
    • Kocher, R.1    Roberts, B.2
  • 17
    • 84886719809 scopus 로고    scopus 로고
    • Cancer drugs in the United States: Justum pretium-the just price
    • Hagop M. Kantarjian et al., Cancer Drugs in the United States: Justum Pretium-The Just Price, 31 J. CLINICAL ONCOLOGY 3600, 3602 (2013)
    • (2013) J. Clinical Oncology , vol.31 , Issue.3600 , pp. 3602
    • Kantarjian, H.M.1
  • 18
    • 84881320765 scopus 로고    scopus 로고
    • Stock market returns and clinical trial results of investigational compounds: An event study analysis of large biopharmaceutical companies
    • Aug.
    • See Thomas J. Hwang, Stock Market Returns and Clinical Trial Results of Investigational Compounds: An Event Study Analysis of Large Biopharmaceutical Companies, PLOS ONE, Aug. 2013, at 6 ("Our results indicate that clinical development events have material economic implications, even for large biopharmaceutical companies with multidrug portfolios. . .")
    • (2013) Plos One
    • Hwang, T.J.1
  • 19
    • 80054882455 scopus 로고    scopus 로고
    • Company stock prices before and after public announcements related to oncology drugs
    • Jeffrey M. Rothenstein et al., Company Stock Prices Before and After Public Announcements Related to Oncology Drugs, 103 J. NAT'L CANCER INST. 1507, 1507 (2011) ("Phase III clinical trials and regulatory decisions by the US Food and Drug Administration (FDA) are high-profile events that are critical for the financial success of new drugs. These events can also have a substantial impact on the market valuation of the companies that might bring these drugs to market. Therefore, these events attract great interest from investors.") 27
    • (2011) J. Nat'l Cancer Inst. , vol.103 , Issue.1507 , pp. 1507
    • Rothenstein, J.M.1
  • 20
    • 84892726671 scopus 로고    scopus 로고
    • Clinical trial evidence supporting fda approval of novel therapeutic agents, 2005-2012
    • Nicholas S. Downing et al., Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012, 311 JAMA 368, 372 (2014) (describing the variation in clinical trial evidence across indications)
    • (2014) JAMA , vol.311 , Issue.368 , pp. 372
    • Downing, N.S.1
  • 21
    • 84875425022 scopus 로고    scopus 로고
    • Number of patients studied prior to approval of new medicines: A database analysis
    • Ruben G. Duijnhoven et al., Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis, 10 PLOS MED. e1001407 (2013)
    • (2013) Plos Med , vol.10 , pp. e1001407
    • Duijnhoven, R.G.1
  • 22
    • 79958036418 scopus 로고    scopus 로고
    • Characteristics of clinical trials to support approval of orphan vs. Nonorphan drugs for cancer
    • Aaron S. Kesselheim et al., Characteristics of Clinical Trials to Support Approval of Orphan vs. Nonorphan Drugs for Cancer, 305 JAMA 2320, 2320 (2011)
    • (2011) JAMA , vol.305 , Issue.2320 , pp. 2320
    • Kesselheim, A.S.1
  • 23
    • 70149120097 scopus 로고    scopus 로고
    • Pivotal studies of orphan drugs approved for neurological diseases
    • Jun Mitsumoto et al., Pivotal Studies of Orphan Drugs Approved for Neurological Diseases, 66 ANNALS NEUROLOGY 184, 189 (2009)
    • (2009) Annals Neurology , vol.66 , Issue.184 , pp. 189
    • Mitsumoto, J.1
  • 24
    • 0037472837 scopus 로고    scopus 로고
    • Non-inferiority trials: Design concepts and issues
    • See Ralph B. D'Agostino, Sr. et al., Non-Inferiority Trials: Design Concepts and Issues, 22 STAT. MED. 169, 169 (2003)
    • (2003) Stat. Med. , vol.22 , Issue.169 , pp. 169
    • D'Agostino, R.B.1
  • 25
    • 84917682487 scopus 로고    scopus 로고
    • Noninferiority trials: Clinical understandings and misunderstandings
    • See John H. Powers & Thomas R. Fleming, Noninferiority Trials: Clinical Understandings and Misunderstandings, 3 CLINICAL INVESTIGATIONS 215, 216 (2013) ("The formulation of the [non-inferiority] margin is often controversial. Sponsors interested in conducting smaller trials and increasing the likelihood of achieving 'positive' results prefer large margins. However, to avoid exposing patients to meaningfully less-effective new interventions, there should be rigorous scientific justification for the [non-inferiority] margin.")
    • (2013) Clinical Investigations , vol.3 , Issue.215 , pp. 216
    • Powers, J.H.1    Fleming, T.R.2
  • 26
    • 79955510087 scopus 로고    scopus 로고
    • Through the looking glass: Understanding non-inferiority
    • Jennifer Schumi & Janet T. Wittes, Through the Looking Glass: Understanding Non-Inferiority, 12 TRIALS 106, 112 (2011) ("Although non-inferiority trials are often conceptually desirable, operational difficulties may plague the process of choosing the margin, either because of insufficient data to support a selected margin or a calculated margin that leads to an impractical sample size.").
    • (2011) Trials , vol.12 , Issue.106 , pp. 112
    • Schumi, J.1    Wittes, J.T.2
  • 27
    • 0025868362 scopus 로고
    • Cost of innovation in the pharmaceutical industry
    • See Joseph A. DiMasi et al., Cost of Innovation in the Pharmaceutical Industry, 10 J. HEALTH ECON. 107, 132-33 (1991)
    • (1991) J. Health Econ. , vol.10 , Issue.107 , pp. 132-133
    • DiMasi, J.A.1
  • 28
    • 84892682239 scopus 로고    scopus 로고
    • Dry antibiotic pipeline: Regulatory bottlenecks and regulatory reforms
    • See Sandeep Kumar Gupta & Roopa P. Nayak, Dry Antibiotic Pipeline: Regulatory Bottlenecks and Regulatory Reforms, 5 J. PHARMACOLOGY & PHARMACOTHERAPEUTICS 4, 6 (2014).
    • (2014) J. PHARMACOLOGY & PHARMACOTHERAPEUTICS , vol.5 , Issue.4 , pp. 6
    • Gupta, S.K.1    Nayak, R.P.2
  • 29
    • 84898691384 scopus 로고    scopus 로고
    • DRUGS@FDA, FDA, https://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
    • DRUGS@FDA, FDA
  • 30
    • 84892737444 scopus 로고    scopus 로고
    • Assessment of us pathway for approving medical devices for rare conditions
    • See Thomas J. Hwang et al., Assessment of US Pathway for Approving Medical Devices for Rare Conditions, 348 BRIT. MED. J. 1, 1-2 (2014) (describing data extraction from FDA's publicly available regulatory review dossiers) [hereinafter Hwang et al., Assessment]
    • (2014) Brit Med. J. , vol.348 , Issue.1 , pp. 1-2
    • Hwang, T.J.1
  • 31
    • 84899845894 scopus 로고    scopus 로고
    • Postmarketing trials and pediatric device approvals
    • Thomas J. Hwang et al., Postmarketing Trials and Pediatric Device Approvals, 133 PEDIATRICS e1197, e1198 (2014)
    • (2014) PEDIATRICS , vol.133 , pp. e1198
    • Hwang, T.J.1
  • 32
    • 0001884644 scopus 로고
    • Individual comparisons by ranking method
    • Frank Wilcoxon, Individual Comparisons by Ranking Method, 1 BIOMETRICS BULL. 80, 81-82 (1945).
    • (1945) Biometrics Bull , vol.1 , Issue.80 , pp. 81-82
    • Wilcoxon, F.1
  • 33
    • 84896794819 scopus 로고    scopus 로고
    • [http://perma.cc/K523-DHA5]
    • See History, STATACORP LP, http://www.stata.com/company/[http://perma.cc/K523-DHA5].
    • STATACORP LP
  • 34
    • 84896973049 scopus 로고    scopus 로고
    • New fda breakthrough-drug category-implications for patients
    • Jonathan J. Darrow et al., New FDA Breakthrough-Drug Category-Implications for Patients, 370 NEW ENG. J. MED. 1252, 1252-53 (2014)
    • (2014) New Eng. J. Med. , vol.370 , Issue.1252 , pp. 1252-1253
    • Darrow, J.J.1
  • 35
    • 84907855577 scopus 로고    scopus 로고
    • Existing fda pathways have potential to ensure early access to, and appropriate use of, specialty drugs
    • Aaron S. Kesselheim et al., Existing FDA Pathways Have Potential to Ensure Early Access to, and Appropriate Use of, Specialty Drugs, 33 HEALTH AFF. 1770, 1772 (2014)
    • (2014) HEALTH AFF. , vol.33 , Issue.1770 , pp. 1772
    • Kesselheim, A.S.1
  • 36
    • 84987977261 scopus 로고    scopus 로고
    • Oct. 12 [http://perma.cc/77XP-SBHR];
    • See Press Release, Rebiotix, Receives Breakthrough Therapy Designation for RBX2660 (Oct. 12, 2015) http://www.rebiotix.com/news-media/press-releases/rebiotix-receives-breakthrough-therapydesignation-for-rbx2660-recurrent-c-diff/[http://perma.cc/77XP-SBHR];
    • (2015) Rebiotix, Receives Breakthrough Therapy Designation for RBX2660
    • Press Release1
  • 39
    • 84987947433 scopus 로고    scopus 로고
    • [http://perma.cc/6KPZ-LB7Y]
    • Compare § 505(b)(1), with § 505(b)(2); see also FDA, GUIDANCE FOR INDUSTRY: APPLICATIONS COVERED BY SECTION 505(B)(2), at 2 (1999), http://www.fda.gov/downloads/Drugs/./Guidances/ucm079345.pdf [http://perma.cc/6KPZ-LB7Y] (describing the types of evidence that can be accepted as part of a 505(b)(2) application).
    • (1999) Guidance for Industry: Applications Covered by Section , vol.505
    • FDA1
  • 40
    • 84931263717 scopus 로고    scopus 로고
    • Feb. 25, [http://perma.cc/6E5ZSW9R]
    • See Press Release, FDA, FDA Approves New Antibacterial Drug Avycaz (Feb. 25, 2015), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435629.htm [http://perma.cc/6E5ZSW9R].
    • (2015) FDA Approves New Antibacterial Drug Avycaz
    • FDA1
  • 41
    • 84927574043 scopus 로고    scopus 로고
    • Ceftazidime-avibactam and comparator agents tested against urinary tract isolates from a global surveillance program
    • See Robert K. Flamm et al., Ceftazidime-Avibactam and Comparator Agents Tested against Urinary Tract Isolates from a Global Surveillance Program, 80 DIAGNOSTIC MICROBIOLOGY INFECTIOUS DISEASE 233, 233 (2014) ("Ceftazidime-avibactam is a combination agent consisting of the non-ß-lactam ß-lactamase inhibitor avibactam and the broad-spectrum cephalosporin, ceftazidime. In this combination, avibactam protects ceftazidime from hydrolysis by ß-lactamases, thus preserving antibacterial activity.")
    • (2014) Diagnostic Microbiology Infectious Disease , vol.80 , Issue.233 , pp. 233
    • Flamm, R.K.1
  • 42
    • 84896833758 scopus 로고    scopus 로고
    • Antimicrobial activity of ceftazidime-avibactam against gram-negative organisms collected from U.S. Medical centers in 2012
    • Helio S. Sader et al., Antimicrobial Activity of Ceftazidime-Avibactam Against Gram-Negative Organisms Collected from U.S. Medical Centers in 2012, 58 ANTIMICROBIAL AGENTS CHEMOTHERAPY 1684, 1684 (2014)
    • (2014) Antimicrobial Agents Chemotherapy , vol.58 , Issue.1684 , pp. 1684
    • Sader, H.S.1
  • 43
    • 84857173233 scopus 로고    scopus 로고
    • In vitro antibacterial activity of the ceftazidime-avibactam (NXL104) Combination against pseudomonas aeruginosa clinical isolates
    • Premavathy Levasseur et al., In Vitro Antibacterial Activity of the Ceftazidime-Avibactam (NXL104) Combination Against Pseudomonas aeruginosa Clinical Isolates, 56 ANTIMICROBIAL AGENTS CHEMOTHERAPY 1606, 1606 (2012)
    • (2012) Antimicrobial Agents Chemotherapy , vol.56 , Issue.1606 , pp. 1606
    • Levasseur, P.1
  • 44
    • 84987977249 scopus 로고    scopus 로고
    • Flexibility or formal pathway? Avycaz suggests fda doesn't need congress to expedite limited use antibiotics
    • May 18 [http://perma.cc/DB3B-KQRD]
    • Bridget Silverman, Flexibility Or Formal Pathway? Avycaz Suggests FDA Doesn't Need Congress To Expedite Limited Use Antibiotics, PINK SHEET (May 18, 2015), https://www.pharmamedtechbi.com/publications/the-pink-sheet/77/20/flexibility-or-formal-pathwayemavycazem-suggests-fda-doesnt-need-congress-to-expedite-limite [http://perma.cc/DB3B-KQRD]
    • (2015) PINK SHEET
    • Silverman, B.1
  • 46
    • 0036834373 scopus 로고    scopus 로고
    • The future challenges facing the development of new antimicrobial drugs
    • See Anthony Coates et al., The Future Challenges Facing the Development of New Antimicrobial Drugs, 1 NATURE REVS. DRUG DISCOVERY 895, 895 (2002) ("No new classes of antibiotics were produced in the 37 years between the introduction of nalidixic acid in 1962 and linezolid in 2000; all of the antibacterial agents that entered the market during this period were modifications of existing molecules.").
    • (2002) Nature Revs. Drug Discovery , vol.1 , Issue.895 , pp. 895
    • Coates, A.1
  • 47
    • 35148881612 scopus 로고    scopus 로고
    • Letter to the Editor, the FDA animal efficacy rule and biodefense
    • See Gigi Kwik Gronvall et al., Letter to the Editor, The FDA Animal Efficacy Rule and Biodefense, 25 NATURE BIOTECHNOLOGY 1084, 1084-85 (2007)
    • (2007) Nature Biotechnology , vol.25 , Issue.1084 , pp. 1084-1085
    • Gronvall, G.K.1
  • 49
    • 67650500264 scopus 로고    scopus 로고
    • Raxibacumab for the treatment of inhalational anthrax
    • See Thi-Sau Migone et al., Raxibacumab for the Treatment of Inhalational Anthrax, 361 NEW ENG. J. MED. 135, 136 (2009) ("We conducted randomized, placebo-controlled studies in two animal models of inhalational anthrax to assess the efficacy of raxibacumab administered as a prophylactic agent and after the onset of systemic disease.").
    • (2009) New Eng. J. Med. , vol.361 , Issue.135 , pp. 136
    • Migone, T.1
  • 53
    • 84987969781 scopus 로고    scopus 로고
    • Mar. 26, http://perma.cc/YR56-UZNA
    • See Marion Gruber, Dir., Office of Vaccines Research & Review, Presentation at the Inst. of Med.'s Fast Track Dev. of Ebola Vaccines (Mar. 26, 2015), http://www.nationalacademies.org/hmd/~/media/Files/Activity%20Files/PublicHealth/MedPrep/Gruber%20I OM%20March%2026.pdf [http://perma.cc/YR56-UZNA] ("Ebola vaccines could be licensed based on clinical endpoint efficacy studies, studies that show an effect on a marker reasonably likely to predict clinical benefit, or animal studies. Accelerated Approval and approval under the Animal Rule considered if Ebola infection rates do not permit direct assessment of efficacy in clinical trials, or for vaccines not being evaluated in current efficacy trials.").
    • (2015) Dir., Office of Vaccines Research & Review, Presentation at the Inst. of Med.'s Fast Track Dev. of Ebola Vaccines
    • Gruber, M.1
  • 54
    • 84924806083 scopus 로고    scopus 로고
    • Oct. 21 [http://perma.cc/2XU9-BT2Z].
    • See World Health Org., Ebola Situation Report (Oct. 21, 2015), http://apps.who.int/iris/bitstream/10665/190067/1/ebolasitrep-21Oct2015-eng.pdf [http://perma.cc/2XU9-BT2Z].
    • (2015) Ebola Situation Report
    • World Health Org.1
  • 55
    • 84940952795 scopus 로고    scopus 로고
    • Efficacy and effectiveness of an rvsv-vectored vaccine expressing ebola surface glycoprotein: Interim results from the Guinea ring vaccination cluster-randomised trial
    • See Ana Maria Henao-Restrepo et al., Efficacy and Effectiveness of an rVSV-vectored Vaccine Expressing Ebola Surface Glycoprotein: Interim Results from the Guinea Ring Vaccination Cluster-Randomised Trial, 386 LANCET 857, 862-64 (2015) (describing results from an interim analysis of a trial of rVSV-ZEBOV in Guinea, West Africa)
    • (2015) LANCET , vol.386 , Issue.857 , pp. 862-864
    • Henao-Restrepo, A.M.1
  • 56
    • 85011081815 scopus 로고    scopus 로고
    • A recombinant vesicular stomatitis virus ebola vaccine-preliminary report
    • (online), apr. http://perma.cc/3CZK-ZM69
    • J. A. Regules et al., A Recombinant Vesicular Stomatitis Virus Ebola Vaccine-Preliminary Report, NEW ENG. J. MED. (ONLINE), Apr. 1, 2015, at 2, http://www.nejm.org/doi/pdf/10.1056/NEJMoa1414216 [http://perma.cc/3CZK-ZM69] ("On the basis of the data presented here and additional clinical and preclinical data, the rVSV-ZEBOV vaccine (at the dose of 20 million PFU) was selected for inclusion in the Partnership for Research on Ebola Vaccines in Liberia trial, a recently initiated phase 3 efficacy study in Guinea, and the soon-to-be-initiated phase 3 Sierra Leone Trial to Introduce a Vaccine against Ebola.") 91
    • (2015) New Eng. J. Med. , vol.1
    • Regules, J.A.1
  • 57
    • 84907424398 scopus 로고    scopus 로고
    • Evaluating novel therapies during the ebola epidemic
    • Joffe, Evaluating Novel Therapies During the Ebola Epidemic, 312 JAMA 1299, 1299-1300 (2014) (describing key considerations for conduct of clinical trials for Ebola)
    • (2014) JAMA , vol.312 , Issue.1299 , pp. 1299-1300
    • Joffe1
  • 58
    • 84928764750 scopus 로고    scopus 로고
    • As ebola wanes trials jockey for patients
    • Kai Kupferschmidt, As Ebola Wanes, Trials Jockey for Patients, 348 SCIENCE 20, 20 (2015) ("But recent successes in reining in the epidemic have created a problem for the international teams running clinical trials: Patients are becoming scarce. That creates moral and scientific quandaries-and even arguments between research teams competing for access to patients.")
    • (2015) Science , vol.348 , Issue.20 , pp. 20
    • Kupferschmidt, K.1
  • 59
    • 84925337680 scopus 로고    scopus 로고
    • Editorial ebola vaccines: An uncertain future?
    • Zoe Mullan, Editorial, Ebola Vaccines: An Uncertain Future?, 3 LANCET GLOBAL HEALTH e113, e113 (2015) ("[R]egulators are showing signs of flexibility in terms of accelerated licensure in the event that the waning epidemic delays the ability to demonstrate efficacy.")
    • (2015) Lancet Global Health , vol.3 , Issue.E113 , pp. e113
    • Mullan, Z.1
  • 60
    • 84924953484 scopus 로고    scopus 로고
    • Ethical considerations of experimental interventions in the ebola outbreak
    • Annette Rid & Ezekiel J. Emanuel, Ethical Considerations of Experimental Interventions in the Ebola Outbreak, 384 LANCET 1896, 1898 (2014) ("Even if clinical trials happen during this Ebola outbreak, additional research will probably be needed in a future epidemic.").
    • (2014) Lancet , vol.384 , Issue.1896 , pp. 1898
    • Rid, A.1    Emanuel, E.J.2
  • 61
    • 84987963187 scopus 로고    scopus 로고
    • May 12 [http://perma.cc/8SKL-ERDJ]
    • See FDA, Briefing Document: Licensure of Ebola Vaccines: Demonstration of Effectiveness 10 (May 12, 2015), http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM445819.pdf [http://perma.cc/8SKL-ERDJ]
    • (2015) Briefing Document: Licensure of Ebola Vaccines: Demonstration of Effectiveness , vol.10
    • FDA1
  • 62
    • 84930933863 scopus 로고    scopus 로고
    • Accelerating innovation in rapid diagnostics and targeted antibacterials
    • See, e.g., Thomas J. Hwang et al., Accelerating Innovation in Rapid Diagnostics and Targeted Antibacterials, 33 NATURE BIOTECHNOLOGY 589, 590 (2015) ("[T]he FDA may need to explore other policy mechanisms to ensure that mandatory post-approval trials are completed in a timely fashion. For example, approval via the pilot program could be subject to a 'sunset' provision corresponding to the deadline for data submission from any post-approval studies.").
    • (2015) Nature Biotechnology , vol.33 , Issue.589 , pp. 590
    • Hwang, T.J.1
  • 63
    • 84987950947 scopus 로고    scopus 로고
    • Power (Sample Size) Calculators, SEALED ENVELOPE (2016), https://www.sealedenvelope.com/power/binary-superiority/.
    • (2016) Power (Sample Size) Calculators
  • 64
    • 84885102013 scopus 로고    scopus 로고
    • Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009
    • See Kevin Outterson et al., Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980-2009, 41 J.L. MED. & ETHICS 688, 692 (2013) ("Few of the withdrawn antibiotics were commercially successful (n=3, although commercial sales data were available for 1993-2009 only) and most were discontinued from the market several years before formal withdrawal.").
    • (2013) J.L. MED. & ETHICS , vol.41 , Issue.688 , pp. 692
    • Outterson, K.1
  • 65
    • 84923875606 scopus 로고    scopus 로고
    • Paying for innovation: Reimbursement incentives for antibiotics
    • Feb. 25
    • See Thomas J. Hwang et al., Paying for Innovation: Reimbursement Incentives for Antibiotics, SCI. TRANSLATIONAL MED. Feb. 25, 2015
    • (2015) SCI. Translational Med.
    • Hwang, T.J.1
  • 66
    • 78649695936 scopus 로고    scopus 로고
    • Fighting antibiotic resistance: Marrying new financial incentives to meeting public health goals
    • Aaron S. Kesselheim & Kevin Outterson, Fighting Antibiotic Resistance: Marrying New Financial Incentives to Meeting Public Health Goals, 29 HEALTH AFF. 1689, 1689 (2010)
    • (2010) Health Aff. , vol.29 , Issue.1689 , pp. 1689
    • Kesselheim, A.S.1    Outterson, K.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.