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Volumn 26, Issue 2, 2015, Pages 300-306

Rare Cancers Europe (RCE) methodological recommendations for clinical studies in rare cancers: A European consensus position paper

(61)  Casali, Paolo G a   Bruzzi, P b   Bogaerts, J c   Blay, J Y d   Aapro, M e   Adamous, A f   Berruti, A g   Bressington, J h   Bruzzi, B b   Capocaccia, R i   Cardoso, F j   Celis, J E k   Cervantes, A l   Ciardiello, F m   Claussen, C n   Coleman, M o   Comis, S p   Craine, S q   De Boltz, D r   De Lorenzo, F s   more..


Author keywords

Clinical trials; Rare cancers; Research methodology

Indexed keywords

TUMOR MARKER;

EID: 84925297669     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdu459     Document Type: Review
Times cited : (76)

References (27)
  • 1
    • 80755140638 scopus 로고    scopus 로고
    • Rare cancers are not so rare: the rare cancer burden in Europe
    • Gatta G, van der Zwan JM, Casali PG et al. Rare cancers are not so rare: the rare cancer burden in Europe. Eur J Cancer 2011; 47: 2493-2511.
    • (2011) Eur J Cancer , vol.47 , pp. 2493-2511
    • Gatta, G.1    van der Zwan, J.M.2    Casali, P.G.3
  • 4
    • 34047133773 scopus 로고    scopus 로고
    • Evidence-based medicine for rare diseases: implications for data interpretation and clinical trial design
    • Behera M, Kumar A, Soares HP et al. Evidence-based medicine for rare diseases: implications for data interpretation and clinical trial design. Cancer Control 2007; 14: 160-166.
    • (2007) Cancer Control , vol.14 , pp. 160-166
    • Behera, M.1    Kumar, A.2    Soares, H.P.3
  • 5
    • 0037707487 scopus 로고    scopus 로고
    • Strategy for randomised clinical trials in rare cancers
    • Tan SB, Dear KB, Bruzzi P, Machin D. Strategy for randomised clinical trials in rare cancers. Br Med J 2003; 327: 47-49.
    • (2003) Br Med J , vol.327 , pp. 47-49
    • Tan, S.B.1    Dear, K.B.2    Bruzzi, P.3    Machin, D.4
  • 6
    • 0023787079 scopus 로고
    • Principles of clinical trial design
    • Piantadosi S. Principles of clinical trial design. Semin Oncol 1988; 15: 423-433.
    • (1988) Semin Oncol , vol.15 , pp. 423-433
    • Piantadosi, S.1
  • 7
    • 79952065109 scopus 로고    scopus 로고
    • Clinical trials and rare diseases
    • Gerss JW, Ko¨pcke W. Clinical trials and rare diseases. Adv Exp Med Biol 2010; 686: 173-190.
    • (2010) Adv Exp Med Biol , vol.686 , pp. 173-190
    • Gerss, J.W.1    Ko¨pcke, W.2
  • 8
    • 84899911233 scopus 로고    scopus 로고
    • American Society of Clinical Oncology Perspective: raising the bar for clinical trials by defining clinically meaningful outcomes
    • Ellis LM, Bernstein DS, Voest EE et al. American Society of Clinical Oncology Perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol 2014; 32: 1277-1280.
    • (2014) J Clin Oncol , vol.32 , pp. 1277-1280
    • Ellis, L.M.1    Bernstein, D.S.2    Voest, E.E.3
  • 9
    • 78651290757 scopus 로고    scopus 로고
    • Demystify statistical significance-time to move on from the p value to Bayesian analysis
    • Lee JJ. Demystify statistical significance-time to move on from the p value to Bayesian analysis. J Natl Cancer Inst 2011; 103: 2-3.
    • (2011) J Natl Cancer Inst , vol.103 , pp. 2-3
    • Lee, J.J.1
  • 10
    • 84859438491 scopus 로고    scopus 로고
    • Adaptive clinical trials in oncology
    • Berry DA. Adaptive clinical trials in oncology. Nat Rev Clin Oncol 2011; 9: 199-207.
    • (2011) Nat Rev Clin Oncol , vol.9 , pp. 199-207
    • Berry, D.A.1
  • 11
    • 84861329551 scopus 로고    scopus 로고
    • Adaptive designs at European Organisation for Research and Treatment of Cancer (EORTC) with a focus on adaptive sample size re-estimation based on interim-effect size
    • Mauer M, Collette L, Bogaerts J; European Organisation for Research and Treatment of Cancer Statistics Department. Adaptive designs at European Organisation for Research and Treatment of Cancer (EORTC) with a focus on adaptive sample size re-estimation based on interim-effect size. Eur J Cancer 2012; 48: 1386-1391.
    • (2012) Eur J Cancer , vol.48 , pp. 1386-1391
    • Mauer, M.1    Collette, L.2    Bogaerts, J.3
  • 12
    • 72249115118 scopus 로고    scopus 로고
    • Bayesian statistics in oncology: a guide for the clinical investigator
    • Adamina M, Tomlinson G, Guller U. Bayesian statistics in oncology: a guide for the clinical investigator. Cancer 2009; 115: 5371-5381.
    • (2009) Cancer , vol.115 , pp. 5371-5381
    • Adamina, M.1    Tomlinson, G.2    Guller, U.3
  • 13
    • 0029586133 scopus 로고
    • Clinical trials and rare diseases: a way out of a conundrum
    • Lilford RJ, Thornton JG, Braunholtz D. Clinical trials and rare diseases: a way out of a conundrum. Br Med J 1995; 311: 1621-1625.
    • (1995) Br Med J , vol.311 , pp. 1621-1625
    • Lilford, R.J.1    Thornton, J.G.2    Braunholtz, D.3
  • 14
    • 77953127347 scopus 로고    scopus 로고
    • Biomarkers and surrogate end points-the challenge of statistical validation
    • Buyse M, Sargent DJ, Grothey A et al. Biomarkers and surrogate end points-the challenge of statistical validation. Nat Rev Clin Oncol 2010; 7: 309-317.
    • (2010) Nat Rev Clin Oncol , vol.7 , pp. 309-317
    • Buyse, M.1    Sargent, D.J.2    Grothey, A.3
  • 15
    • 0000830674 scopus 로고
    • Meaningful clinical classification of therapeutic responses to anticancer drugs
    • Karnofsky DA. Meaningful clinical classification of therapeutic responses to anticancer drugs. Clin Pharmac Ther 1961; 2: 709-712.
    • (1961) Clin Pharmac Ther , vol.2 , pp. 709-712
    • Karnofsky, D.A.1
  • 16
    • 57849117384 scopus 로고    scopus 로고
    • New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
    • Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45: 228-247.
    • (2009) Eur J Cancer , vol.45 , pp. 228-247
    • Eisenhauer, E.A.1    Therasse, P.2    Bogaerts, J.3
  • 17
    • 0031797332 scopus 로고    scopus 로고
    • Phase I and II trials of novel anti-cancer agents: endpoints, efficacy and existential. The Michel Clavel Lecture, held at the 10th NCI-EORTC Conference on New Drugs in Cancer Therapy, Amsterdam, 16-19 June 1998
    • Eisenhauer EA. Phase I and II trials of novel anti-cancer agents: endpoints, efficacy and existentialism. The Michel Clavel Lecture, held at the 10th NCI-EORTC Conference on New Drugs in Cancer Therapy, Amsterdam, 16-19 June 1998. Ann Oncol 1998; 9: 1047-1052.
    • (1998) Ann Oncol , vol.9 , pp. 1047-1052
    • Eisenhauer, E.A.1
  • 18
    • 79952065108 scopus 로고    scopus 로고
    • Creating a European Union framework for actions in the field of rare diseases
    • Moliner AM. Creating a European Union framework for actions in the field of rare diseases. Adv Exp Med Biol 2010; 686: 457-473.
    • (2010) Adv Exp Med Biol , vol.686 , pp. 457-473
    • Moliner, A.M.1
  • 19
    • 84884536477 scopus 로고    scopus 로고
    • How should clinical trial data be shared?
    • Tucker ME. How should clinical trial data be shared? Br Med J 2013; 347: f4465.
    • (2013) Br Med J , vol.347
    • Tucker, M.E.1
  • 20
    • 84921448168 scopus 로고    scopus 로고
    • Second-opinion pathologic review is a patient safety mechanism that helps reduce error and decrease waste
    • Middleton LP, Feeley TW, Albright HW et al. Second-opinion pathologic review is a patient safety mechanism that helps reduce error and decrease waste. J Oncol Pract 2014; 10: 275-280.
    • (2014) J Oncol Pract , vol.10 , pp. 275-280
    • Middleton, L.P.1    Feeley, T.W.2    Albright, H.W.3
  • 21
    • 84887841279 scopus 로고    scopus 로고
    • Histopathologic diagnosis of pediatric neoplasms: a review of international consultations
    • Santiago TC, Jenkins JJ. Histopathologic diagnosis of pediatric neoplasms: a review of international consultations. Arch Pathol Lab Med 2013; 137: 1648-1653.
    • (2013) Arch Pathol Lab Med , vol.137 , pp. 1648-1653
    • Santiago, T.C.1    Jenkins, J.J.2
  • 22
    • 84864851590 scopus 로고    scopus 로고
    • Sarcoma: concordance between initial diagnosis and centralized expert review in a population-based study within three European regions
    • Ray-Coquard I, Montesco MC, Coindre JM et al. Sarcoma: concordance between initial diagnosis and centralized expert review in a population-based study within three European regions. Ann Oncol 2012; 23: 2442-2449.
    • (2012) Ann Oncol , vol.23 , pp. 2442-2449
    • Ray-Coquard, I.1    Montesco, M.C.2    Coindre, J.M.3
  • 23
    • 84862777400 scopus 로고    scopus 로고
    • Adaptive licensing: taking the next step in the evolution of drug approval
    • Eichler HG, Oye K, Baird LG et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin Pharmacol Ther 2012; 91: 426-437.
    • (2012) Clin Pharmacol Ther , vol.91 , pp. 426-437
    • Eichler, H.G.1    Oye, K.2    Baird, L.G.3
  • 24
    • 37349006685 scopus 로고    scopus 로고
    • The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO)
    • Casali PG. The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO). Ann Oncol 2007; 18: 1923-1925.
    • (2007) Ann Oncol , vol.18 , pp. 1923-1925
    • Casali, P.G.1
  • 25
    • 80655139255 scopus 로고    scopus 로고
    • Can broad consent be informed consent?
    • Sheehan M, Martin J. Can broad consent be informed consent? Publ Health Ethics 2011; 4: 226-235.
    • (2011) Publ Health Ethics , vol.4 , pp. 226-235
    • Sheehan, M.1    Martin, J.2
  • 26
    • 84882449721 scopus 로고    scopus 로고
    • Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem?
    • Steinsbekk KS, Myskja BK, Solberg B. Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem? Eur J Hum Gen 2013; 21: 897-902.
    • (2013) Eur J Hum Gen , vol.21 , pp. 897-902
    • Steinsbekk, K.S.1    Myskja, B.K.2    Solberg, B.3
  • 27
    • 84929842173 scopus 로고    scopus 로고
    • Cancer registration, public health and the reform of the European data protection framework: abandoning or improving European public health research?
    • October 10 [Epub ahead of print]
    • Andersen MR, Storm HH; on behalf of the Eurocourse Work Package 2 Group. Cancer registration, public health and the reform of the European data protection framework: abandoning or improving European public health research? Eur J Cancer 2013 October 10 [Epub ahead of print], doi: 10.1016/j.ejca.2013.09.005.
    • (2013) Eur J Cancer
    • Andersen, M.R.1    Storm, H.H.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.