메뉴 건너뛰기




Volumn 7, Issue SEP, 2016, Pages

Payers' views of the changes arising through the possible adoption of adaptive pathways

(31)  Ermisch, Michael a   Bucsics, Anna b   Bonanno, Patricia Vella c   Arickx, Francis d   Bybau, Alexander e   Bochenek, Tomasz f   van de Casteele, Marc d   Diogene, Eduardo g   Fürst, Jurij h   Garuoliene, Kristina i,j   van der Graaff, Martin k   Gulbinovic, Jolanta i,l   Haycox, Alan m   Jones, Jan n   Joppi, Roberta o   Laius, Ott p   Langner, Irene q   Martin, Antony P m   Markovic Pekovic, Vanda r,s   McCullagh, Laura t   more..


Author keywords

Adaptive pathways; EMA; Europe; Marketing authorization; Payers

Indexed keywords

NEW DRUG;

EID: 84991786795     PISSN: None     EISSN: 16639812     Source Type: Journal    
DOI: 10.3389/fphar.2016.00305     Document Type: Article
Times cited : (46)

References (62)
  • 1
    • 77953066585 scopus 로고    scopus 로고
    • Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers
    • Adamski, J., Godman, B., Ofierska-Sujkowska, G., Osinska, B., Herholz, H., Wendykowska, K., et al. (2010). Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Services Res. 10:153. doi: 10.1186/1472-6963-10-153
    • (2010) BMC Health Services Res , vol.10 , pp. 153
    • Adamski, J.1    Godman, B.2    Ofierska-Sujkowska, G.3    Osinska, B.4    Herholz, H.5    Wendykowska, K.6
  • 2
    • 84886944875 scopus 로고    scopus 로고
    • Comparative effectiveness research and measuring the level of pharmaceutical innovation in the EU
    • Annemans, L., Cleemput, I., Hulstaert, F., and Simoens, S. (2012). Comparative effectiveness research and measuring the level of pharmaceutical innovation in the EU. J. Comp. Effectiv. Res. 1, 19-29. doi: 10.2217/cer.11.1
    • (2012) J. Comp. Effectiv. Res , vol.1 , pp. 19-29
    • Annemans, L.1    Cleemput, I.2    Hulstaert, F.3    Simoens, S.4
  • 3
    • 79551575056 scopus 로고    scopus 로고
    • Trial watch: phase III and submission failures: 2007-2010
    • Arrowsmith, J. (2011). Trial watch: phase III and submission failures: 2007-2010. Nat. Rev. Drug Disc. 10:87. doi: 10.1038/nrd3375
    • (2011) Nat. Rev. Drug Disc , vol.10 , pp. 87
    • Arrowsmith, J.1
  • 5
    • 84943661661 scopus 로고    scopus 로고
    • Approvals of drugs with uncertain benefit-risk profiles in Europe
    • Banzi, R., Gerardi, C., Bertele, V., and Garattini, S. (2015). Approvals of drugs with uncertain benefit-risk profiles in Europe. Eur. J. Inter. Med. 26, 572-584. doi: 10.1016/j.ejim.2015.08.008
    • (2015) Eur. J. Inter. Med , vol.26 , pp. 572-584
    • Banzi, R.1    Gerardi, C.2    Bertele, V.3    Garattini, S.4
  • 6
    • 84905916889 scopus 로고    scopus 로고
    • New expensive treatments for hepatitis C infection
    • Brennan, T., and Shrank, W. (2014). New expensive treatments for hepatitis C infection. JAMA 312, 593-594. doi: 10.1001/jama.2014.8897
    • (2014) JAMA , vol.312 , pp. 593-594
    • Brennan, T.1    Shrank, W.2
  • 9
    • 84904634733 scopus 로고    scopus 로고
    • Dabigatran: how the drug company withheld important analyses
    • Cohen, D. (2014). Dabigatran: how the drug company withheld important analyses. BMJ 349:g4670. doi: 10.1136/bmj.g4670
    • (2014) BMJ , vol.349
    • Cohen, D.1
  • 10
    • 84916915741 scopus 로고    scopus 로고
    • Are payers treating orphan drugs differently?
    • Cohen, P., and Felix, A. (2014). Are payers treating orphan drugs differently? J. Market Access Health Pol. 2:23513. doi: 10.3402/jmahp.v2.23513
    • (2014) J. Market Access Health Pol , vol.2 , pp. 23513
    • Cohen, P.1    Felix, A.2
  • 11
    • 84904188903 scopus 로고    scopus 로고
    • Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis
    • Cortazar, P., Zhang, L., Untch, M., Mehta, K., Costantino, J. P., Wolmark, N., et al. (2014). Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet 384, 164-172. doi: 10.1016/S0140-6736(13)62422-8
    • (2014) Lancet , vol.384 , pp. 164-172
    • Cortazar, P.1    Zhang, L.2    Untch, M.3    Mehta, K.4    Costantino, J.P.5    Wolmark, N.6
  • 12
    • 84991747631 scopus 로고    scopus 로고
    • "Adaptive pathways" to drug authorisation: adapting to industry?
    • Davis, C., Lexchin, J., Jefferson, T., Gotzsche, P., and McKee, M. (2016). "Adaptive pathways" to drug authorisation: adapting to industry? BMJ open. BMJ 354:i4437. doi: 10.1136/bmj.i4437
    • (2016) BMJ open. BMJ , vol.354 , pp. i4437
    • Davis, C.1    Lexchin, J.2    Jefferson, T.3    Gotzsche, P.4    McKee, M.5
  • 13
    • 84981505057 scopus 로고    scopus 로고
    • Introduction and Utilization of High Priced HCV Medicines across Europe; Implications for the Future
    • de Bruijn, W., Ibanez, C., Frisk, P., Bak Pedersen, H., Alkan, A., Vella Bonanno, P., et al. (2016). Introduction and Utilization of High Priced HCV Medicines across Europe; Implications for the Future. Front. Pharmacol. 7:197. doi: 10.3389/fphar.2016.00197
    • (2016) Front. Pharmacol , vol.7 , pp. 197
    • de Bruijn, W.1    Ibanez, C.2    Frisk, P.3    Bak Pedersen, H.4    Alkan, A.5    Vella Bonanno, P.6
  • 14
    • 79960048069 scopus 로고    scopus 로고
    • Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response
    • Eichler, H. G., Abadie, E., Breckenridge, A., Flamion, B., Gustafsson, L. L., Leufkens, H., et al. (2011). Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response. Nat. Rev. Drug Disc. 10, 495-506. doi: 10.1038/nrd3501
    • (2011) Nat. Rev. Drug Disc , vol.10 , pp. 495-506
    • Eichler, H.G.1    Abadie, E.2    Breckenridge, A.3    Flamion, B.4    Gustafsson, L.L.5    Leufkens, H.6
  • 15
    • 84927675287 scopus 로고    scopus 로고
    • From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients
    • Eichler, H. G., Baird, L., Barker, R., Bloechl-Daum, B., Borlum-Kristensen, F., Brown, J., et al. (2015). From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients. Clin. Pharmacol. Ther. 97, 234-246. doi: 10.1002/cpt.59
    • (2015) Clin. Pharmacol. Ther , vol.97 , pp. 234-246
    • Eichler, H.G.1    Baird, L.2    Barker, R.3    Bloechl-Daum, B.4    Borlum-Kristensen, F.5    Brown, J.6
  • 16
    • 84966588586 scopus 로고    scopus 로고
    • Drug regulation and pricing-can regulators influence affordability?
    • Eichler, H. G., Hurts, H., Broich, K., and Rasi, G. (2016). Drug regulation and pricing-can regulators influence affordability? New Engl. J. Med. 374, 1807-1809. doi: 10.1056/NEJMp1601294
    • (2016) New Engl. J. Med , vol.374 , pp. 1807-1809
    • Eichler, H.G.1    Hurts, H.2    Broich, K.3    Rasi, G.4
  • 17
    • 84862777400 scopus 로고    scopus 로고
    • Adaptive licensing: taking the next step in the evolution of drug approval
    • Eichler, H. G., Oye, K., Baird, L. G., Abadie, E., Brown, J., Drum, C. L., et al. (2012). Adaptive licensing: taking the next step in the evolution of drug approval. Clin. Pharmacol. Ther. 91, 426-437. doi: 10.1038/clpt.2011.345
    • (2012) Clin. Pharmacol. Ther , vol.91 , pp. 426-437
    • Eichler, H.G.1    Oye, K.2    Baird, L.G.3    Abadie, E.4    Brown, J.5    Drum, C.L.6
  • 18
    • 84880790088 scopus 로고    scopus 로고
    • The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts
    • Experts in Chronic Myeloid Leukemia (2013). The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood 121, 4439-4442. doi: 10.1182/blood-2013-03-490003
    • (2013) Blood , vol.121 , pp. 4439-4442
  • 20
    • 84910654404 scopus 로고    scopus 로고
    • Dealing with uncertainty and high prices of new medicines: a comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden
    • Ferrario, A., and Kanavos, P. (2015). Dealing with uncertainty and high prices of new medicines: a comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden. Soc. Sci. Med. 124, 39-47. doi: 10.1016/j.socscimed.2014.11.003
    • (2015) Soc. Sci. Med , vol.124 , pp. 39-47
    • Ferrario, A.1    Kanavos, P.2
  • 21
    • 84905494407 scopus 로고    scopus 로고
    • Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals
    • Frank, C., Himmelstein, D. U., Woolhandler, S., Bor, D. H., Wolfe, S. M., Heymann, O., et al. (2014). Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals. Health Affairs 33, 1453-1459. doi: 10.1377/hlthaff.2014.0122
    • (2014) Health Affairs , vol.33 , pp. 1453-1459
    • Frank, C.1    Himmelstein, D.U.2    Woolhandler, S.3    Bor, D.H.4    Wolfe, S.M.5    Heymann, O.6
  • 22
    • 84857058164 scopus 로고    scopus 로고
    • Time to revisit the orphan drug law
    • Garattini, S. (2012). Time to revisit the orphan drug law. Eur. J. Clin. Pharmacol. 68, 113. doi: 10.1007/s00228-011-1115-3
    • (2012) Eur. J. Clin. Pharmacol , vol.68 , pp. 113
    • Garattini, S.1
  • 25
    • 84916931880 scopus 로고    scopus 로고
    • Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?
    • Godman, B., Malmstrom, R. E., Diogene, E., Gray, A., Jayathissa, S., Timoney, A., et al. (2015). Are new models needed to optimize the utilization of new medicines to sustain healthcare systems? Exp. Rev. Clin. Pharmacol. 8, 77-94. doi: 10.1586/17512433.2015.990380
    • (2015) Exp. Rev. Clin. Pharmacol , vol.8 , pp. 77-94
    • Godman, B.1    Malmstrom, R.E.2    Diogene, E.3    Gray, A.4    Jayathissa, S.5    Timoney, A.6
  • 26
    • 84904859153 scopus 로고    scopus 로고
    • Dabigatran-a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs
    • Godman, B., Malmstrom, R. E., Diogene, E., Jayathissa, S., McTaggart, S., Cars, T., et al. (2014). Dabigatran-a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs. Front. Pharmacol. 5:109. doi: 10.3389/fphar.2014.00109
    • (2014) Front. Pharmacol , vol.5 , pp. 109
    • Godman, B.1    Malmstrom, R.E.2    Diogene, E.3    Jayathissa, S.4    McTaggart, S.5    Cars, T.6
  • 27
    • 84864186594 scopus 로고    scopus 로고
    • Prescribing restrictions-a necessary strategy among some European countries to enhance future prescribing efficiency?'
    • Godman, B., Malmstrom, R., Bennie, M., Sakshaug, S., Burkhardt, T., Campbell, S., Garuoliene, K., Lonsdale, J., et al. (2012a). Prescribing restrictions-a necessary strategy among some European countries to enhance future prescribing efficiency?'. Rev. Health Care. 3, 5-16. doi: 10.7175/rhc.v3i1.55
    • (2012) Rev. Health Care , vol.3 , pp. 5-16
    • Godman, B.1    Malmstrom, R.2    Bennie, M.3    Sakshaug, S.4    Burkhardt, T.5    Campbell, S.6    Garuoliene, K.7    Lonsdale, J.8
  • 29
    • 79952781964 scopus 로고    scopus 로고
    • Policies to enhance prescribing efficiency in europe: findings and future implications
    • Godman, B., Shrank, W., Andersen, M., Berg, C., Bishop, I., Burkhardt, T., et al. (2010). Policies to enhance prescribing efficiency in europe: findings and future implications. Front. Pharmacol. 1:141. doi: 10.3389/fphar.2010.00141
    • (2010) Front. Pharmacol , vol.1 , pp. 141
    • Godman, B.1    Shrank, W.2    Andersen, M.3    Berg, C.4    Bishop, I.5    Burkhardt, T.6
  • 30
    • 84991816506 scopus 로고    scopus 로고
    • Specialists attack drug agency's fast track approval scheme
    • Hawkes, N. (2016a). Specialists attack drug agency's fast track approval scheme. BMJ 353:i3060. doi: 10.1136/bmj.i3060
    • (2016) BMJ , vol.353 , pp. i3060
    • Hawkes, N.1
  • 31
    • 84991759122 scopus 로고    scopus 로고
    • German body calls for pause in European plan for fast track drug approval
    • Hawkes, N. (2016b). German body calls for pause in European plan for fast track drug approval. BMJ 354:i4479. doi: 10.1136/bmj.i4479
    • (2016) BMJ , vol.354 , pp. i4479
    • Hawkes, N.1
  • 32
    • 84905093578 scopus 로고    scopus 로고
    • Understanding the role and evidence expectations of health technology assessment and coverage/payer bodies: what are they looking for, and how and why does this differ from what regulators require?
    • Henshall, C. S. L., Eichler, H.-G., Lemgruber, A., Longson, C., O'Rourke, B., and Tunis, S. (2014). Understanding the role and evidence expectations of health technology assessment and coverage/payer bodies: what are they looking for, and how and why does this differ from what regulators require? Ther. Inn. Regul. Sci. 48, 341-346. doi: 10.1177/2168479013512488
    • (2014) Ther. Inn. Regul. Sci , vol.48 , pp. 341-346
    • Henshall, C.S.L.1    Eichler, H.-G.2    Lemgruber, A.3    Longson, C.4    O'Rourke, B.5    Tunis, S.6
  • 33
    • 84922419758 scopus 로고    scopus 로고
    • Pricing in the market for anticancer drugs
    • Howard, D. H., Bach, P., Berndt, E. R., and Conti, R. M. (2015). Pricing in the market for anticancer drugs. J. Econ. Persp. 29, 139-162. doi: 10.1257/jep.29.1.139
    • (2015) J. Econ. Persp , vol.29 , pp. 139-162
    • Howard, D.H.1    Bach, P.2    Berndt, E.R.3    Conti, R.M.4
  • 34
    • 84914710771 scopus 로고    scopus 로고
    • Adaptive approaches to licensing, health technology assessment, and introduction of drugs and devices
    • Husereau, D., Henshall, C., and Jivraj, J. (2014). Adaptive approaches to licensing, health technology assessment, and introduction of drugs and devices. Int. J. Technol. Assess. Health Care 30, 241-249. doi: 10.1017/S0266462314000191
    • (2014) Int. J. Technol. Assess. Health Care , vol.30 , pp. 241-249
    • Husereau, D.1    Henshall, C.2    Jivraj, J.3
  • 35
    • 84939864059 scopus 로고    scopus 로고
    • Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations
    • Hyman, D. M., Puzanov, I., Subbiah, V., Faris, J. E., Chau, I., Blay, J. Y., et al. (2015). Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations. NEJM 373, 726-736. doi: 10.1056/NEJMoa1502309
    • (2015) NEJM , vol.373 , pp. 726-736
    • Hyman, D.M.1    Puzanov, I.2    Subbiah, V.3    Faris, J.E.4    Chau, I.5    Blay, J.Y.6
  • 36
    • 85028311250 scopus 로고    scopus 로고
    • Brussels: International Society of Drug Bulletins, Medicines in Europe Forum, Nordic Cochrane Centre. 31 August Press Release
    • International Society of Drug Bulletins (2016). EMA's Report on Adaptive Pathways: Little Data and Much Ado About Nothing. Brussels: International Society of Drug Bulletins, Medicines in Europe Forum, Nordic Cochrane Centre. 31 August Press Release. Available online at: http://english.prescrire.org/en/79/207/46302/4983/4785/SubReportDetails.aspx
    • (2016) EMA's Report on Adaptive Pathways: Little Data and Much Ado About Nothing
  • 37
    • 84878317563 scopus 로고    scopus 로고
    • Hospitalized patients with atrial fibrillation compared to those included in recent trials on novel oral anticoagulants: a population-based study
    • Joppi, R., Cinconze, E., Mezzalira, L., Pase, D., Poggiani, C., Rossi, E., et al. (2013). Hospitalized patients with atrial fibrillation compared to those included in recent trials on novel oral anticoagulants: a population-based study. Eur. J. Int. Med. 24, 318-323. doi: 10.1016/j.ejim.2013.02.018
    • (2013) Eur. J. Int. Med , vol.24 , pp. 318-323
    • Joppi, R.1    Cinconze, E.2    Mezzalira, L.3    Pase, D.4    Poggiani, C.5    Rossi, E.6
  • 39
    • 84976610769 scopus 로고    scopus 로고
    • Letting post-marketing bridge the evidence gap: the case of orphan drugs
    • Joppi, R., Gerardi, C., Bertele', V., and Garattini, S. (2016). Letting post-marketing bridge the evidence gap: the case of orphan drugs. BMJ 353:i2978. doi: 10.1136/bmj.i2978
    • (2016) BMJ , vol.353 , pp. i2978
    • Joppi, R.1    Gerardi, C.2    Bertele', V.3    Garattini, S.4
  • 40
    • 84886719809 scopus 로고    scopus 로고
    • Cancer drugs in the United States: Justum Pretium-the just price
    • Kantarjian, H. M., Fojo, T., Mathisen, M., and Zwelling, L. A. (2013). Cancer drugs in the United States: Justum Pretium-the just price. J. Clin. Oncol. 31, 3600-3604. doi: 10.1200/JCO.2013.49.1845
    • (2013) J. Clin. Oncol , vol.31 , pp. 3600-3604
    • Kantarjian, H.M.1    Fojo, T.2    Mathisen, M.3    Zwelling, L.A.4
  • 42
    • 84896721523 scopus 로고    scopus 로고
    • Delivering maximum clinical benefit at an affordable price: engaging stakeholders in cancer care
    • Kelly, R. J., and Smith, T. J. (2014). Delivering maximum clinical benefit at an affordable price: engaging stakeholders in cancer care. Lancet Oncol. 15, e112-e118. doi: 10.1016/S1470-2045(13)70578-3
    • (2014) Lancet Oncol , vol.15 , pp. e112-e118
    • Kelly, R.J.1    Smith, T.J.2
  • 43
  • 45
    • 84881534674 scopus 로고    scopus 로고
    • Dabigatran-a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs
    • Malmstrom, R. E., Godman, B. B., Diogene, E., Baumgartel, C., Bennie, M., Bishop, I., et al. (2013). Dabigatran-a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. Front. Pharmacol. 4:39. doi: 10.3389/fphar.2013.00039
    • (2013) Front. Pharmacol , vol.4 , pp. 39
    • Malmstrom, R.E.1    Godman, B.B.2    Diogene, E.3    Baumgartel, C.4    Bennie, M.5    Bishop, I.6
  • 47
    • 84975853000 scopus 로고    scopus 로고
    • Clinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysis
    • Marra, L. P., Araujo, V. E., Silva, T. B., Diniz, L. M., Guerra Junior, A. A., Acurcio, F. A., et al. (2016). Clinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysis. Diabetes Ther. 7, 241-258. doi: 10.1007/s13300-016-0166-y
    • (2016) Diabetes Ther , vol.7 , pp. 241-258
    • Marra, L.P.1    Araujo, V.E.2    Silva, T.B.3    Diniz, L.M.4    Guerra Junior, A.A.5    Acurcio, F.A.6
  • 48
    • 84942838711 scopus 로고    scopus 로고
    • Improving the managed introduction of new medicines: sharing experiences to aid authorities across Europe
    • Matusewicz, W., Godman, B., Pedersen, H. B., Furst, J., Gulbinovic, J., Mack, A., et al. (2015). Improving the managed introduction of new medicines: sharing experiences to aid authorities across Europe. Exp. Rev. Pharmacoeconom. Outcomes Res. 15, 755-758. doi: 10.1586/14737167.2015.1085803
    • (2015) Exp. Rev. Pharmacoeconom. Outcomes Res , vol.15 , pp. 755-758
    • Matusewicz, W.1    Godman, B.2    Pedersen, H.B.3    Furst, J.4    Gulbinovic, J.5    Mack, A.6
  • 49
    • 84947708886 scopus 로고    scopus 로고
    • Rethinking the appraisal and approval of drugs for type 2 diabetes
    • Naci, H., Lehman, R., Wouters, O. J., Goldacre, B., and Yudkin, J. S. (2015). Rethinking the appraisal and approval of drugs for type 2 diabetes. BMJ 351:h5260. doi: 10.1136/bmj.h5260
    • (2015) BMJ , vol.351
    • Naci, H.1    Lehman, R.2    Wouters, O.J.3    Goldacre, B.4    Yudkin, J.S.5
  • 50
    • 84884590185 scopus 로고    scopus 로고
    • OECD Health Working Papers, No. 63 OECD Publishing
    • Paris, V., and Belloni, A. (2013). Value in Pharmaceutical Pricing. OECD Health Working Papers, No. 63: OECD Publishing. doi: 10.1787/5k43jc9v6knx-en
    • (2013) Value in Pharmaceutical Pricing
    • Paris, V.1    Belloni, A.2
  • 51
    • 85028361949 scopus 로고    scopus 로고
    • Managing new premium-priced medicines in Europe
    • Permanand, G., and Bak Pedersen, H. (2015). Managing new premium-priced medicines in Europe. J. Pharmaceut. Policy Pract. 8(Suppl. 1), 1-3. doi: 10.1186/2052-3211-8-s1-k2
    • (2015) J. Pharmaceut. Policy Pract , vol.8 , pp. 1-3
    • Permanand, G.1    Bak Pedersen, H.2
  • 52
    • 84929502677 scopus 로고    scopus 로고
    • A treatment revolution for those who can afford it? Hepatitis C treatment: new medications, profits and patients
    • Phelan, M., and Cook, C. (2014). A treatment revolution for those who can afford it? Hepatitis C treatment: new medications, profits and patients. BMC Infect. Dis. 14 (Suppl. 6):S5. doi: 10.1186/1471-2334-14-S6-S5
    • (2014) BMC Infect. Dis , vol.14 , pp. S5
    • Phelan, M.1    Cook, C.2
  • 53
    • 84885450999 scopus 로고    scopus 로고
    • Clinical evidence for orphan medicinal products-a cause for concern?
    • Picavet, E., Cassiman, D., Hollak, C. E., Maertens, J. A., and Simoens, S. (2013). Clinical evidence for orphan medicinal products-a cause for concern? Orphanet J. Rare Dis. 8, 164. doi: 10.1186/1750-1172-8-164
    • (2013) Orphanet J. Rare Dis , vol.8 , pp. 164
    • Picavet, E.1    Cassiman, D.2    Hollak, C.E.3    Maertens, J.A.4    Simoens, S.5
  • 54
    • 84939825159 scopus 로고    scopus 로고
    • The strength of association between surrogate end points and survival in oncology: a systematic review of trial-level meta-analyses
    • Prasad, V., Kim, C., Burotto, M., and Vandross, A. (2015). The strength of association between surrogate end points and survival in oncology: a systematic review of trial-level meta-analyses. JAMA Int. Med. 175, 1389-1398. doi: 10.1001/jamainternmed.2015.2829
    • (2015) JAMA Int. Med , vol.175 , pp. 1389-1398
    • Prasad, V.1    Kim, C.2    Burotto, M.3    Vandross, A.4
  • 55
    • 84991751584 scopus 로고    scopus 로고
    • New drugs, new indications in 2015: little progress, and threats to access to quality healthcare for all
    • Prescrire Editorial (2016). New drugs, new indications in 2015: little progress, and threats to access to quality healthcare for all. Rev. Prescrire 36, 133-137.
    • (2016) Rev. Prescrire , vol.36 , pp. 133-137
  • 56
    • 77953704571 scopus 로고    scopus 로고
    • Multiple sclerosis risk sharing scheme: a costly failure
    • Raftery, J. (2010). Multiple sclerosis risk sharing scheme: a costly failure. BMJ 340:c1672. doi: 10.1136/bmj.c1672
    • (2010) BMJ , vol.340
    • Raftery, J.1
  • 57
    • 84927154472 scopus 로고    scopus 로고
    • Basket trials and the evolution of clinical trial design in an era of genomic medicine
    • Redig, A. J., and Janne, P. A. (2015). Basket trials and the evolution of clinical trial design in an era of genomic medicine. J. Clin. Oncol. 33, 975-977. doi: 10.1200/JCO.2014.59.8433
    • (2015) J. Clin. Oncol , vol.33 , pp. 975-977
    • Redig, A.J.1    Janne, P.A.2
  • 58
    • 84873476022 scopus 로고    scopus 로고
    • Cost-effectiveness assessment of orphan drugs: a scientific and political conundrum
    • Simoens, S., Picavet, E., Dooms, M., Cassiman, D., and Morel, T. (2013). Cost-effectiveness assessment of orphan drugs: a scientific and political conundrum. Appl. Health Econ. Health Policy 11, 1-3. doi: 10.1007/s40258-012-0004-y
    • (2013) Appl. Health Econ. Health Policy , vol.11 , pp. 1-3
    • Simoens, S.1    Picavet, E.2    Dooms, M.3    Cassiman, D.4    Morel, T.5
  • 59
    • 84876802600 scopus 로고    scopus 로고
    • Surrogate outcomes in clinical trials: a cautionary tale
    • Svensson, S., Menkes, D. B., and Lexchin, J. (2013). Surrogate outcomes in clinical trials: a cautionary tale. JAMA Int. Med. 173, 611-612. doi: 10.1001/jamainternmed.2013.3037
    • (2013) JAMA Int. Med , vol.173 , pp. 611-612
    • Svensson, S.1    Menkes, D.B.2    Lexchin, J.3
  • 60
    • 70449717243 scopus 로고    scopus 로고
    • Progression-free survival remains debatable endpoint in cancer trials
    • Tuma, R. (2009). Progression-free survival remains debatable endpoint in cancer trials. J. Natl. Cancer Ins. 101, 1439-1441. doi: 10.1093/jnci/djp399
    • (2009) J. Natl. Cancer Ins , vol.101 , pp. 1439-1441
    • Tuma, R.1
  • 61
    • 70350459560 scopus 로고    scopus 로고
    • Surrogate outcomes in health technology assessment: an international comparison
    • Velasco Garrido, M., and Mangiapane, S. (2009). Surrogate outcomes in health technology assessment: an international comparison. Int. J. Technol. Asses. Health Care 25, 315-322. doi: 10.1017/S0266462309990213
    • (2009) Int. J. Technol. Asses. Health Care , vol.25 , pp. 315-322
    • Velasco Garrido, M.1    Mangiapane, S.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.