-
1
-
-
1942471868
-
Principles of use of surrogate markers and endpoints
-
DOI 10.1016/j.maturitas.2003.11.011, PII S0378512204000179
-
Kluft C. Principles of use of surrogate markers and endpoints. Maturitas 2004; 47(4): 293-298 (Pubitemid 38520115)
-
(2004)
Maturitas
, vol.47
, Issue.4
, pp. 293-298
-
-
Kluft, C.1
-
2
-
-
0036399255
-
Overview of biomarkers and surrogate endpoints in drug development
-
Wagner JA. Overview of biomarkers and surrogate endpoints in drug development. Disease Markers 2002; 18(2): 41-46
-
(2002)
Disease Markers
, vol.18
, Issue.2
, pp. 41-46
-
-
Wagner, J.A.1
-
3
-
-
39449114054
-
Biomarker method validation in anticancer drug development
-
Review [103 refs]
-
Cummings J, Ward TH, Greystoke A, Ranson M, Dive C. Biomarker method validation in anticancer drug development. [Review] [103 refs]. Br J Pharmacol 2008; 153(4): 646-656
-
(2008)
Br J Pharmacol
, vol.153
, Issue.4
, pp. 646-656
-
-
Cummings, J.1
Ward, T.H.2
Greystoke, A.3
Ranson, M.4
Dive, C.5
-
4
-
-
33746559665
-
Imaging biomarkers as surrogate endpoints for drug development
-
Richter WS. Imaging biomarkers as surrogate endpoints for drug development. Eur J Nucl Med Mol Imag 2006; 33(Suppl 1): 6-10.
-
(2006)
Eur J Nucl Med Mol Imag
, vol.33
, Issue.SUPPL. 1
, pp. 6-10
-
-
Richter, W.S.1
-
5
-
-
0037374498
-
The price of innovation: New estimates of drug development costs
-
DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Economics 2003; 22(2): 151-185
-
(2003)
J Health Economics
, vol.22
, Issue.2
, pp. 151-185
-
-
DiMasi, J.A.1
Hansen, R.W.2
Grabowski, H.G.3
-
7
-
-
33750961447
-
Risedronate decreases biochemical markers of cartilage degradation but does not decrease symptoms or slow radiographic progression in patients with medial compartment osteoarthritis of the knee: Results of the two-year multinational knee osteoarthritis structural arthritis study
-
Bingham CO, III, Buckland-Wright JC, Garnero P, et al. Risedronate decreases biochemical markers of cartilage degradation but does not decrease symptoms or slow radiographic progression in patients with medial compartment osteoarthritis of the knee: results of the two-year multinational knee osteoarthritis structural arthritis study. Arthritis Rheumatism 2006; 54(11): 3494-3507
-
(2006)
Arthritis Rheumatism
, vol.54
, Issue.11
, pp. 3494-3507
-
-
Bingham III, C.O.1
Buckland-Wright, J.C.2
Garnero, P.3
-
8
-
-
0033603814
-
Are surrogate markers adequate to assess cardiovascular disease drugs?
-
Temple R. Are surrogate markers adequate to assess cardiovascular disease drugs? JAMA 1999; 282(8): 790-795
-
(1999)
JAMA
, vol.282
, Issue.8
, pp. 790-795
-
-
Temple, R.1
-
9
-
-
0003285230
-
Biomarkers and surrogate endpoints in clinical research: Definitions and conceptual model
-
NIH Definitions Working Group. Downing G, editor Elsevier
-
NIH Definitions Working Group. Biomarkers and surrogate endpoints in clinical research: definitions and conceptual model. In: Downing G, editor. Biomarkers and Surrogate Endpoints: Clinical Research and Applications Amsterdam: Elsevier; 2000; p. 1-9.
-
(2000)
Biomarkers and Surrogate Endpoints: Clinical Research and Applications Amsterdam
, pp. 1-9
-
-
-
10
-
-
39749134121
-
Strategic paths for biomarker qualification
-
Goodsaid FM, Frueh FW, Mattes W. Strategic paths for biomarker qualification. Toxicology 2008; 245(3): 219-223
-
(2008)
Toxicology
, vol.245
, Issue.3
, pp. 219-223
-
-
Goodsaid, F.M.1
Frueh, F.W.2
Mattes, W.3
-
11
-
-
0032234507
-
NIH-FDA Conference: Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications
-
Abstracts
-
NIH-FDA Conference: Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications. Abstracts. Disease Markers 1998; 14(4): 187-334.
-
(1998)
Disease Markers
, vol.14
, Issue.4
, pp. 187-334
-
-
-
12
-
-
0035037328
-
Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: Criteria, validation, strategies
-
[Review] [61 refs]
-
Lesko LJ, Atkinson AJ Jr. Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. [Review] [61 refs]. Annu Rev Pharmacol Toxicol 2001; 41: 347-366
-
(2001)
Annu Rev Pharmacol Toxicol
, vol.41
, pp. 347-366
-
-
Lesko, L.J.1
Atkinson Jr., A.J.2
-
13
-
-
0035100888
-
Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework
-
Biomarkers Definitions Working Group
-
Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Therapeutics 2001; 69(3): 89-95.
-
(2001)
Clin Pharmacol Therapeutics
, vol.69
, Issue.3
, pp. 89-95
-
-
-
14
-
-
12944288028
-
Surrogate endpoints and FDA's accelerated approval process
-
Fleming TR. Surrogate endpoints and FDA's accelerated approval process. Health Affairs 2005; 24(1): 67-78.
-
(2005)
Health Affairs
, vol.24
, Issue.1
, pp. 67-78
-
-
Fleming, T.R.1
-
15
-
-
0030268577
-
Surrogate end points in clinical trials: Are we being misled?
-
Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996; 125(7): 605-613
-
(1996)
Ann Intern Med
, vol.125
, Issue.7
, pp. 605-613
-
-
Fleming, T.R.1
Demets, D.L.2
-
16
-
-
0024520844
-
Surrogate endpoints in clinical trials: Definition and operational criteria
-
Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989; 8(4): 431-440 (Pubitemid 19105891)
-
(1989)
Statistics in Medicine
, vol.8
, Issue.4
, pp. 431-440
-
-
Prentice, R.L.1
-
17
-
-
1542333321
-
-
[cited 2009 Mar 20];Available from: URL: www.fda.gov/cder/guidance/ 6400fnl.pdf
-
US Food and Drug Administration. Guidance for industry - pharmacogenomic data submissions. http://wwwfdagov/cder/guidance/6400fnlpdf 2005 [cited 2009 Mar 20];Available from: URL: www.fda.gov/cder/guidance/6400fnl.pdf
-
Guidance for Industry - Pharmacogenomic Data Submissions
-
-
-
18
-
-
32544451155
-
Fit-for-purpose method development and validation for successful biomarker measurement
-
Lee JW, Devanarayan V, Barrett YC, et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res 2006; 23(2): 312-328
-
(2006)
Pharm Res
, vol.23
, Issue.2
, pp. 312-328
-
-
Lee, J.W.1
Devanarayan, V.2
Barrett, Y.C.3
-
19
-
-
33845974419
-
Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs
-
Wagner JA, Williams SA, Webster CJ. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clin Pharmacol Therapeutics 2007; 81(1):104-107
-
(2007)
Clin Pharmacol Therapeutics
, vol.81
, Issue.1
, pp. 104-107
-
-
Wagner, J.A.1
Williams, S.A.2
Webster, C.J.3
-
20
-
-
34047177929
-
Biomarker qualification pilot process at the US Food and Drug Administration
-
Goodsaid F, Frueh F. Biomarker qualification pilot process at the US Food and Drug Administration. AAPS J 2007; 9(1): E105-8.
-
(2007)
AAPS J
, vol.9
, Issue.1
-
-
Goodsaid, F.1
Frueh, F.2
-
21
-
-
0030884335
-
The contribution of clinical pharmacology surrogates and models to drug development - A critical appraisal
-
Rolan P. The contribution of clinical pharmacology surrogates and models to drug development - a critical appraisal. Br J Clin Pharmacol 1997; 44(3): 219-225 (Pubitemid 27376248)
-
(1997)
British Journal of Clinical Pharmacology
, vol.44
, Issue.3
, pp. 219-225
-
-
Rolan, P.1
-
22
-
-
33745143969
-
A users guide to measurement in medicine
-
Lassere M. A users guide to measurement in medicine. Osteoarthritis Cartilage 2006; 14(Suppl 1): 10-14
-
(2006)
Osteoarthritis Cartilage
, vol.14
, Issue.SUPPL. 1
, pp. 10-14
-
-
Lassere, M.1
-
23
-
-
0031990046
-
The OMERACT filter for Outcome Measures in Rheumatology
-
Boers M, Brooks P, Strand CV, Tugwell P. The OMERACT filter for Outcome Measures in Rheumatology. J Rheumatol 1998; 25(2): 198-199
-
(1998)
J Rheumatol
, vol.25
, Issue.2
, pp. 198-199
-
-
Boers, M.1
Brooks, P.2
Strand, C.V.3
Tugwell, P.4
-
24
-
-
23244451582
-
Biomarkers and Surrogate Markers: An FDA Perspective
-
DOI 10.1602/neurorx.1.2.189, PII S1545534306700347, Biomarkers and Surrogates
-
Katz R. Biomarkers and surrogate markers: an FDA perspective. NeuroRx 2004; 1(2): 189-195 (Pubitemid 46604746)
-
(2004)
NeuroRx
, vol.1
, Issue.2
, pp. 189-195
-
-
Katz, R.1
-
25
-
-
48049115014
-
The Biomarker-Surrogacy Evaluation Schema: A review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints
-
Lassere MN. The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints. Stat Methods Med Res 2008; 17(3): 303-340
-
(2008)
Stat Methods Med Res
, vol.17
, Issue.3
, pp. 303-340
-
-
Lassere, M.N.1
-
26
-
-
2642571931
-
Statistical validation of surrogate endpoints: Is bone density a valid surrogate for fracture?
-
Li Z, Chines AA, Meredith MP. Statistical validation of surrogate endpoints: is bone density a valid surrogate for fracture?. J Musculoskeletal Neuronal Interact 2004; 4(1): 64-74. (Pubitemid 38714796)
-
(2004)
Journal of Musculoskeletal Neuronal Interactions
, vol.4
, Issue.1
, pp. 64-74
-
-
Li, Z.1
Chines, A.A.2
Meredith, M.P.3
-
28
-
-
0026739680
-
Surrogate endpoints: A basis for a rational approach
-
[Review] [19 refs]
-
Boissel JP, Collet JP, Moleur P, Haugh M. Surrogate endpoints: a basis for a rational approach. [Review] [19 refs]. Eur J Clin Pharmacol 1992; 43(3): 235-244
-
(1992)
Eur J Clin Pharmacol
, vol.43
, Issue.3
, pp. 235-244
-
-
Boissel, J.P.1
Collet, J.P.2
Moleur, P.3
Haugh, M.4
-
29
-
-
0032033832
-
"Molecular and biochemical markers of Alzheimer's disease". The ronald and nancy reagan research institute of the Alzheimer's association and the national institute on aging working group
-
Consensus report of the Working Group on: [erratum appears in Neurobiol Aging 1998; 19(3): 285]
-
Consensus report of the Working Group on: "Molecular and biochemical markers of Alzheimer's disease". The ronald and nancy reagan research institute of the Alzheimer's association and the national institute on aging working group. [erratum appears in Neurobiol Aging 1998; 19(3): 285]. Neurobiol Aging 1998; 19(2): 109-116
-
(1998)
Neurobiol Aging
, vol.19
, Issue.2
, pp. 109-116
-
-
-
30
-
-
0034802767
-
Considerations in the evaluation of surrogate endpoints in clinical trials. Summary of a National Institutes of Health workshop
-
De Gruttola VG, Clax P, DeMets DL, et al. Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop. Control Clin Trials 2001; 22(5): 485-502.
-
(2001)
Control Clin Trials
, vol.22
, Issue.5
, pp. 485-502
-
-
De Gruttola, V.G.1
Clax, P.2
Demets, D.L.3
-
31
-
-
31344434774
-
Statistical evaluation of biomarkers as surrogate endpoints: A literature review
-
Weir CJ, Walley RJ. Statistical evaluation of biomarkers as surrogate endpoints: a literature review. Stat Med 2006; 25(2): 183-203.
-
(2006)
Stat Med
, vol.25
, Issue.2
, pp. 183-203
-
-
Weir, C.J.1
Walley, R.J.2
-
32
-
-
33747190312
-
Process map proposal for the validation of genomic biomarkers
-
Goodsaid F, Frueh F. Process map proposal for the validation of genomic biomarkers. Pharmacogenomics 2006; 7(5): 773-782
-
(2006)
Pharmacogenomics
, vol.7
, Issue.5
, pp. 773-782
-
-
Goodsaid, F.1
Frueh, F.2
-
33
-
-
38349160711
-
The Biomarkers Consortium: On the critical path of drug discovery
-
Altar CA. The Biomarkers Consortium: on the critical path of drug discovery. Clin Pharmacol Therapeutics 2008; 83(2): 361-364
-
(2008)
Clin Pharmacol Therapeutics
, vol.83
, Issue.2
, pp. 361-364
-
-
Altar, C.A.1
-
34
-
-
33847381474
-
Biomarkers in the prevention and treatment of atherosclerosis: Need, validation, and future
-
Revkin JH, Shear CL, Pouleur HG, Ryder SW, Orloff DG. Biomarkers in the prevention and treatment of atherosclerosis: need, validation, and future. Pharmacological Rev 2007; 59(1): 40-53.
-
(2007)
Pharmacological Rev
, vol.59
, Issue.1
, pp. 40-53
-
-
Revkin, J.H.1
Shear, C.L.2
Pouleur, H.G.3
Ryder, S.W.4
Orloff, D.G.5
-
35
-
-
77951032859
-
-
[cited 2009 Mar 17]; Available from: URL: http://www.fda.gov/oc/ initiatives/criticalpath
-
FDA. Critical Path Initiative. http://www fda gov/oc/initiatives/ criticalpath/ 2009 [cited 2009 Mar 17]; Available from: URL: http://www.fda.gov/oc/initiatives/criticalpath/
-
(2009)
-
-
-
36
-
-
77951027031
-
-
[cited 2009 Mar 17]; Available from: URL: http://www.fda.gov/oc/ initiatives/criticalpath/reports/opp-report.pdf
-
FDA. Critical Path Opportunities Report and List. http://www fda gov/oc/initiatives/criticalpath/reports/opp-reportpdf 2006 [cited 2009 Mar 17]; Available from: URL: http://www.fda.gov/oc/initiatives/criticalpath/reports/opp- report.pdf
-
(2006)
-
-
-
38
-
-
0142094504
-
Is knee radiography useful for studying the efficacy of a disease-modifying osteoarthritis drug in humans?
-
Mazzuca SA, Brandt KD. Is knee radiography useful for studying the efficacy of a disease-modifying osteoarthritis drug in humans? Rheum Dis Clin North Am 2003; 29(4): 819-830
-
(2003)
Rheum Dis Clin North Am
, vol.29
, Issue.4
, pp. 819-830
-
-
Mazzuca, S.A.1
Brandt, K.D.2
-
39
-
-
4043130370
-
Pitfalls in the accurate measurement of joint space narrowing in semiflexed, anteroposterior radiographic imaging of the knee
-
Mazzuca SA, Brandt KD, Buckwalter KA, Lequesne M. Pitfalls in the accurate measurement of joint space narrowing in semiflexed, anteroposterior radiographic imaging of the knee. Arthritis Rheum 2004; 50(8): 2508-2515
-
(2004)
Arthritis Rheum
, vol.50
, Issue.8
, pp. 2508-2515
-
-
Mazzuca, S.A.1
Brandt, K.D.2
Buckwalter, K.A.3
Lequesne, M.4
-
40
-
-
14644390255
-
The Vioxx debacle
-
Alpert JS. The Vioxx debacle. Am J Med 2005; 118(3): 203-204
-
(2005)
Am J Med
, vol.118
, Issue.3
, pp. 203-204
-
-
Alpert, J.S.1
-
42
-
-
33747013778
-
Change in joint space width: Hyaline articular cartilage loss or alteration in meniscus?
-
Hunter DJ, Zhang YQ, Tu X, et al. Change in joint space width: hyaline articular cartilage loss or alteration in meniscus? Arthritis Rheum 2006; 54(8): 2488-2495
-
(2006)
Arthritis Rheum
, vol.54
, Issue.8
, pp. 2488-2495
-
-
Hunter, D.J.1
Zhang, Y.Q.2
Tu, X.3
-
43
-
-
0034080616
-
Analysis of the discordance between radiographic changes and knee pain in osteoarthritis of the knee
-
Hannan MT, Felson DT, Pincus T. Analysis of the discordance between radiographic changes and knee pain in osteoarthritis of the knee. J Rheumatol 2000; 27(6): 1513-1517
-
(2000)
J Rheumatol
, vol.27
, Issue.6
, pp. 1513-1517
-
-
Hannan, M.T.1
Felson, D.T.2
Pincus, T.3
-
44
-
-
34250181733
-
OMERACT/OARSI initiative to define states of severity and indication for joint replacement in hip and knee osteoarthritis
-
Gossec L, Hawker G, Davis AM, et al. OMERACT/OARSI initiative to define states of severity and indication for joint replacement in hip and knee osteoarthritis. J Rheumatol 2007; 34(6): 1432-1435
-
(2007)
J Rheumatol
, vol.34
, Issue.6
, pp. 1432-1435
-
-
Gossec, L.1
Hawker, G.2
Davis, A.M.3
-
45
-
-
0031000842
-
An approach to the validation of markers for use in AIDS clinical trials
-
[Review] [184 refs]
-
Mildvan D, Landay A, De GV, Machado SG, Kagan J. An approach to the validation of markers for use in AIDS clinical trials. [Review] [184 refs]. Clin Infec Dis 1997; 24(5): 764-774
-
(1997)
Clin Infec Dis
, vol.24
, Issue.5
, pp. 764-774
-
-
Mildvan, D.1
Landay, A.2
De, G.V.3
Machado, S.G.4
Kagan, J.5
-
46
-
-
33745615815
-
Classification of osteoarthritis biomarkers: A proposed approach
-
Bauer DC, Hunter DJ, Abramson SB, et al. Classification of osteoarthritis biomarkers: a proposed approach. Osteoarthritis Cartilage 2006; 14(8): 723-727
-
(2006)
Osteoarthritis Cartilage
, vol.14
, Issue.8
, pp. 723-727
-
-
Bauer, D.C.1
Hunter, D.J.2
Abramson, S.B.3
-
47
-
-
34147109828
-
The Biomarkers Consortium: Public and private sectors working in partnership to improve the public health
-
Zerhouni EA, Sanders CA, von Eschenbach AC. The Biomarkers Consortium: public and private sectors working in partnership to improve the public health. Oncologist 2007; 12(3): 250-252
-
(2007)
Oncologist
, vol.12
, Issue.3
, pp. 250-252
-
-
Zerhouni, E.A.1
Sanders, C.A.2
Von Eschenbach, A.C.3
-
48
-
-
33847628809
-
Definitions and validation criteria for biomarkers and surrogate endpoints: Development and testing of a quantitative hierarchical levels of evidence schema
-
[24 refs]
-
Lassere MN, Johnson KR, Boers M, et al. Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema. [24 refs]. J Rheumatol 2007; 34(3): 607-615
-
(2007)
J Rheumatol
, vol.34
, Issue.3
, pp. 607-615
-
-
Lassere, M.N.1
Johnson, K.R.2
Boers, M.3
-
49
-
-
33745712124
-
Joint National Cancer Institute-Food and Drug Administration workshop on research strategies, study designs, and statistical approaches to biomarker validation for cancer diagnosis and detection
-
Jun
-
Maruvada P, Srivastava S. Joint National Cancer Institute-Food and Drug Administration workshop on research strategies, study designs, and statistical approaches to biomarker validation for cancer diagnosis and detection. Cancer Epidemiol Biomarkers Prevent 2006 Jun;15(6):1078-1082
-
(2006)
Cancer Epidemiol Biomarkers Prevent
, vol.15
, Issue.6
, pp. 1078-1082
-
-
Maruvada, P.1
Srivastava, S.2
-
50
-
-
2142827148
-
An inauspicious start for the US National Biospecimen Network
-
Birmingham K. An inauspicious start for the US National Biospecimen Network. J Clin Investig 2004; 113(3): 320.
-
(2004)
J Clin Investig
, vol.113
, Issue.3
, pp. 320
-
-
Birmingham, K.1
-
51
-
-
13844309784
-
NCI's National Biospecimen Network: Too early or too late?
-
Hede K. NCI's National Biospecimen Network: too early or too late? J Natl Cancer Inst 2005; 97(4): 247-248
-
(2005)
J Natl Cancer Inst
, vol.97
, Issue.4
, pp. 247-248
-
-
Hede, K.1
-
52
-
-
4344675055
-
Statistical considerations in combining biomarkers for disease classification
-
Feng Z, Yasui Y. Statistical considerations in combining biomarkers for disease classification. Dis Markers 2004; 20(2): 45-51.
-
(2004)
Dis Markers
, vol.20
, Issue.2
, pp. 45-51
-
-
Feng, Z.1
Yasui, Y.2
-
53
-
-
0036713833
-
Combining several screening tests: Optimality of the risk score
-
McIntosh MW, Pepe MS. Combining several screening tests: optimality of the risk score. Biometrics 2002; 58(3): 657-664
-
(2002)
Biometrics
, vol.58
, Issue.3
, pp. 657-664
-
-
McIntosh, M.W.1
Pepe, M.S.2
|