-
1
-
-
77954634393
-
What constitutes reasonable evidence of efficacy and effectiveness to guide oncology treatment decisions?
-
20237213 10.1634/theoncologist.2010-S1-19 Epub 2010/03/30
-
Sargent D. What constitutes reasonable evidence of efficacy and effectiveness to guide oncology treatment decisions? Oncologist. 2010;15 Suppl 1:19-23. Epub 2010/03/30.
-
(2010)
Oncologist
, vol.15
, Issue.SUPPL. 1
, pp. 19-23
-
-
Sargent, D.1
-
2
-
-
78651320045
-
When are «positive» clinical trials in oncology truly positive?
-
Epub 2010/12/07
-
Ocana A, Tannock IF. When are «positive» clinical trials in oncology truly positive? J Natl Cancer Inst. 2011;103(1):16-20. Epub 2010/12/07. This commentary questions what defines a positive clinical trial in oncology and assessed whether recent publications meet the suggested criteria.
-
(2011)
J Natl Cancer Inst.
, vol.103
, Issue.1
, pp. 16-20
-
-
Ocana, A.1
Tannock, I.F.2
-
3
-
-
84865165918
-
The price we pay for progress: A meta-analysis of harms of newly approved anticancer drugs
-
Epub 2012/07/18
-
Niraula S, Seruga B, Ocana A, Shao T, Goldstein R, Tannock IF, et al. The price we pay for progress: a meta-analysis of harms of newly approved anticancer drugs. J Clin Oncol. 2012;30(24):3012-9. Epub 2012/07/18. This meta-analysis showed that newly approved cancer drugs have significantly higher toxicity than control treatments in randomized trials.
-
(2012)
J Clin Oncol.
, vol.30
, Issue.24
, pp. 3012-3019
-
-
Niraula, S.1
Seruga, B.2
Ocana, A.3
Shao, T.4
Goldstein, R.5
Tannock, I.F.6
-
4
-
-
73349122015
-
Incremental advance or seismic shift? the need to raise the bar of efficacy for drug approval
-
19826122 10.1200/JCO.2009.22.4162 Epub 2009/10/15
-
Sobrero A, Bruzzi P. Incremental advance or seismic shift? The need to raise the bar of efficacy for drug approval. J Clin Oncol. 2009;27(35):5868-73. Epub 2009/10/15.
-
(2009)
J Clin Oncol
, vol.27
, Issue.35
, pp. 5868-5873
-
-
Sobrero, A.1
Bruzzi, P.2
-
5
-
-
33644834827
-
Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: Individual patient data from 20,898 patients on 18 randomized trials
-
16260700 10.1200/JCO.2005.01.6071 Epub 2005/11/02
-
Sargent DJ, Wieand HS, Haller DG, Gray R, Benedetti JK, Buyse M, et al. Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomized trials. J Clin Oncol. 2005;23(34):8664-70. Epub 2005/11/02.
-
(2005)
J Clin Oncol
, vol.23
, Issue.34
, pp. 8664-8670
-
-
Sargent, D.J.1
Wieand, H.S.2
Haller, D.G.3
Gray, R.4
Benedetti, J.K.5
Buyse, M.6
-
6
-
-
71549143528
-
Detecting an overall survival benefit that is derived from progression-free survival
-
Epub 2009/11/12
-
Broglio KR, Berry DA. Detecting an overall survival benefit that is derived from progression-free survival. J Natl Canc Inst. 2009;101(23):1642-9. Epub 2009/11/12. This paper presents statistical modeling about the correlation between progression-free and overall survival, and how survival post-progression can influence this correlation.
-
(2009)
J Natl Canc Inst.
, vol.101
, Issue.23
, pp. 1642-1649
-
-
Broglio, K.R.1
Berry, D.A.2
-
7
-
-
47249152394
-
Endpoints and surrogate endpoints in colorectal cancer: A review of recent developments
-
18525345 10.1097/CCO.0b013e32830218fe Epub 2008/06/06
-
Piedbois P, Buyse M. Endpoints and surrogate endpoints in colorectal cancer: a review of recent developments. Curr Opin Oncol. 2008;20(4):466-71. Epub 2008/06/06.
-
(2008)
Curr Opin Oncol
, vol.20
, Issue.4
, pp. 466-471
-
-
Piedbois, P.1
Buyse, M.2
-
8
-
-
8244254377
-
Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial
-
9196156 1:CAS:528:DyaK2sXlsFKksLY%3D Epub 1997/06/01
-
Burris 3rd HA, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997;15(6):2403-13. Epub 1997/06/01.
-
(1997)
J Clin Oncol
, vol.15
, Issue.6
, pp. 2403-2413
-
-
Burris Iii., H.A.1
Moore, M.J.2
Andersen, J.3
Green, M.R.4
Rothenberg, M.L.5
Modiano, M.R.6
-
9
-
-
34249779568
-
Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma
-
17538086 10.1056/NEJMoa066838 1:CAS:528:DC%2BD2sXmtVKkurs%3D Epub 2007/06/01
-
Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. New Engl J Med. 2007;356(22):2271-81. Epub 2007/06/01.
-
(2007)
New Engl J Med
, vol.356
, Issue.22
, pp. 2271-2281
-
-
Hudes, G.1
Carducci, M.2
Tomczak, P.3
Dutcher, J.4
Figlin, R.5
Kapoor, A.6
-
10
-
-
68749107026
-
Clinical benefit in oncology trials: Is this a patient-centred or tumour-centred end-point?
-
Epub 2009/06/24
-
Ohorodnyk P, Eisenhauer EA, Booth CM. Clinical benefit in oncology trials: is this a patient-centred or tumour-centred end-point? Eur J Canc. 2009;45(13):2249-52. Epub 2009/06/24. Thoughful commentary about the clinical differences between patient-centred and tumor-centred endpoints in clinical trials.
-
(2009)
Eur J Canc.
, vol.45
, Issue.13
, pp. 2249-2252
-
-
Ohorodnyk, P.1
Eisenhauer, E.A.2
Booth, C.M.3
-
11
-
-
0030268577
-
Surrogate end points in clinical trials: Are we being misled?
-
8815760 10.7326/0003-4819-125-7-199610010-00011 1:STN:280: DyaK28zovFWrtA%3D%3D Epub 1996/10/01
-
Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med. 1996;125(7):605-13. Epub 1996/10/01.
-
(1996)
Ann Intern Med
, vol.125
, Issue.7
, pp. 605-613
-
-
Fleming, T.R.1
Demets, D.L.2
-
12
-
-
0036554730
-
End points in cancer clinical trials and the drug approval process
-
11948095 Epub 2002/04/12
-
Schilsky RL. End points in cancer clinical trials and the drug approval process. Clin Cancer Res. 2002;8(4):935-8. Epub 2002/04/12.
-
(2002)
Clin Cancer Res
, vol.8
, Issue.4
, pp. 935-938
-
-
Schilsky, R.L.1
-
13
-
-
79955445696
-
Accelerated approval of oncology products: The food and drug administration experience
-
21422403 10.1093/jnci/djr062 Epub 2011/03/23
-
Johnson JR, Ning YM, Farrell A, Justice R, Keegan P, Pazdur R. Accelerated approval of oncology products: the food and drug administration experience. J Natl Cancer Inst. 2011;103(8):636-44. Epub 2011/03/23.
-
(2011)
J Natl Cancer Inst
, vol.103
, Issue.8
, pp. 636-644
-
-
Johnson, J.R.1
Ning, Y.M.2
Farrell, A.3
Justice, R.4
Keegan, P.5
Pazdur, R.6
-
14
-
-
70349315347
-
Accelerated approval of cancer drugs: Improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?
-
19636013 10.1200/JCO.2008.21.1961 1:CAS:528:DC%2BD1MXht1WisbnI Epub 2009/07/29
-
Richey EA, Lyons EA, Nebeker JR, Shankaran V, McKoy JM, Luu TH, et al. Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs? J Clin Oncol. 2009;27(26):4398-405. Epub 2009/07/29.
-
(2009)
J Clin Oncol
, vol.27
, Issue.26
, pp. 4398-4405
-
-
Richey, E.A.1
Lyons, E.A.2
Nebeker, J.R.3
Shankaran, V.4
McKoy, J.M.5
Luu, T.H.6
-
15
-
-
84862893473
-
Pathological complete response and accelerated drug approval in early breast cancer
-
22646508 10.1056/NEJMp1205737 1:CAS:528:DC%2BC38XhtV2kurrL Epub 2012/06/01
-
Prowell TM, Pazdur R. Pathological complete response and accelerated drug approval in early breast cancer. New Engl J Med. 2012;366(26):2438-41. Epub 2012/06/01.
-
(2012)
New Engl J Med
, vol.366
, Issue.26
, pp. 2438-2441
-
-
Prowell, T.M.1
Pazdur, R.2
-
16
-
-
84856522259
-
Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: Results from the I-SPY 1 TRIAL - CALGB 150007/150012, ACRIN 6657
-
22649152 10.1200/JCO.2011.39.2779 Epub 2012/06/01
-
Esserman LJ, Berry DA, DeMichele A, Carey L, Davis SE, Buxton M, et al. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL - CALGB 150007/150012, ACRIN 6657. J Clin Oncol. 2012;30(26):3242-9. Epub 2012/06/01.
-
(2012)
J Clin Oncol
, vol.30
, Issue.26
, pp. 3242-3249
-
-
Esserman, L.J.1
Berry, D.A.2
Demichele, A.3
Carey, L.4
Davis, S.E.5
Buxton, M.6
-
17
-
-
79959322738
-
Oncogenic targets, magnitude of benefit, and market pricing of antineoplastic drugs
-
Epub 2011/05/25
-
Amir E, Seruga B, Martinez-Lopez J, Kwong R, Pandiella A, Tannock IF, et al. Oncogenic targets, magnitude of benefit, and market pricing of antineoplastic drugs. J Clin Oncol. 2011;29(18):2543-9. Epub 2011/05/25. Meta-analysis assessing the benefit of new anticancer drugs based on mechanism of action. The paper also looked at the correlation between magnitude of benefit and market price.
-
(2011)
J Clin Oncol.
, vol.29
, Issue.18
, pp. 2543-2549
-
-
Amir, E.1
Seruga, B.2
Martinez-Lopez, J.3
Kwong, R.4
Pandiella, A.5
Tannock, I.F.6
-
18
-
-
33947498821
-
Eligibility criteria of randomized controlled trials published in high-impact general medical journals: A systematic sampling review
-
17374817 10.1001/jama.297.11.1233 Epub 2007/03/22
-
Van Spall HG, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA. 2007;297(11):1233-40. Epub 2007/03/22.
-
(2007)
JAMA
, vol.297
, Issue.11
, pp. 1233-1240
-
-
Van Spall, H.G.1
Toren, A.2
Kiss, A.3
Fowler, R.A.4
-
19
-
-
79952768920
-
Clinical research: Show us the data
-
Epub 2011/02/16
-
Ocana A, Amir E, Seruga B. Clinical research: show us the data. J Clin Oncol. 2011;29(9):1099-100. Epub 2011/02/16. Commentary describing how absence of information about clinical trials can lead to difficulties in translating data from clinical trials in to clinical practice.
-
(2011)
J Clin Oncol.
, vol.29
, Issue.9
, pp. 1099-1100
-
-
Ocana, A.1
Amir, E.2
Seruga, B.3
-
20
-
-
80053238941
-
Delivering affordable cancer care in high-income countries
-
Epub 2011/10/01
-
Sullivan R, Peppercorn J, Sikora K, Zalcberg J, Meropol NJ, Amir E, et al. Delivering affordable cancer care in high-income countries. Lancet Oncol. 2011;12(10):933-80. Epub 2011/10/01. An extended commentary assessing measurement of benefit and cost-effectiveness of cancer services in wealthy nations.
-
(2011)
Lancet Oncol.
, vol.12
, Issue.10
, pp. 933-980
-
-
Sullivan, R.1
Peppercorn, J.2
Sikora, K.3
Zalcberg, J.4
Meropol, N.J.5
Amir, E.6
-
21
-
-
34249933404
-
Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: A phase III trial of the National Cancer Institute of Canada Clinical Trials Group
-
17452677 10.1200/JCO.2006.07.9525 1:CAS:528:DC%2BD2sXmvVWmsr0%3D Epub 2007/04/25
-
Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007;25(15):1960-6. Epub 2007/04/25.
-
(2007)
J Clin Oncol
, vol.25
, Issue.15
, pp. 1960-1966
-
-
Moore, M.J.1
Goldstein, D.2
Hamm, J.3
Figer, A.4
Hecht, J.R.5
Gallinger, S.6
-
22
-
-
84875139810
-
Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer
-
Epub 2013/01/11
-
Vera-Badillo FE, Shapiro R, Ocana A, Amir E, Tannock IF. Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer. Ann Oncol. 2013. Epub 2013/01/11. Review of clinical trials in breast cancer assessing the bias in reporting of endpoints of efficacy and toxicity.
-
(2013)
Ann Oncol.
-
-
Vera-Badillo, F.E.1
Shapiro, R.2
Ocana, A.3
Amir, E.4
Tannock, I.F.5
-
23
-
-
77952787734
-
Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes
-
Epub 2010/05/27
-
Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA. 2010;303(20):2058-64. Epub 2010/05/27. Review of trials published in 2006 showing that among studies with statistically nonsignificant primary outcomes, there was frequent spin thereby leading to the reporting and interpretation of findings being inconsistent with the results.
-
(2010)
JAMA.
, vol.303
, Issue.20
, pp. 2058-2064
-
-
Boutron, I.1
Dutton, S.2
Ravaud, P.3
Altman, D.G.4
-
24
-
-
73549124318
-
Population-based differences in treatment outcome following anticancer drug therapies
-
20129130 10.1016/S1470-2045(09)70160-3 Epub 2010/02/05
-
Ma BB, Hui EP, Mok TS. Population-based differences in treatment outcome following anticancer drug therapies. Lancet Oncol. 2010;11(1):75-84. Epub 2010/02/05.
-
(2010)
Lancet Oncol
, vol.11
, Issue.1
, pp. 75-84
-
-
Ma, B.B.1
Hui, E.P.2
Mok, T.S.3
-
25
-
-
79951981575
-
Reporting of serious adverse drug reactions of targeted anticancer agents in pivotal phase III clinical trials
-
Epub 2010/12/08
-
Seruga B, Sterling L, Wang L, Tannock IF. Reporting of serious adverse drug reactions of targeted anticancer agents in pivotal phase III clinical trials. J Clin Oncol. 2011;29(2):174-85. Epub 2010/12/08. A provocative review of differences in the description of serious toxicity between reports in journals and the drug label.
-
(2011)
J Clin Oncol.
, vol.29
, Issue.2
, pp. 174-185
-
-
Seruga, B.1
Sterling, L.2
Wang, L.3
Tannock, I.F.4
-
26
-
-
70350517166
-
Adverse events in randomized trials: Neglected, restricted, distorted, and silenced
-
19858427 10.1001/archinternmed.2009.313 Epub 2009/10/28
-
Ioannidis JP. Adverse events in randomized trials: neglected, restricted, distorted, and silenced. Arch Intern Med. 2009;169(19):1737-9. Epub 2009/10/28.
-
(2009)
Arch Intern Med
, vol.169
, Issue.19
, pp. 1737-1739
-
-
Ioannidis, J.P.1
-
27
-
-
70350489859
-
Reporting of safety results in published reports of randomized controlled trials
-
19858432 10.1001/archinternmed.2009.306 Epub 2009/10/28
-
Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009;169(19):1756-61. Epub 2009/10/28.
-
(2009)
Arch Intern Med
, vol.169
, Issue.19
, pp. 1756-1761
-
-
Pitrou, I.1
Boutron, I.2
Ahmad, N.3
Ravaud, P.4
-
28
-
-
67349105052
-
Inadequate statistical power to detect clinically significant differences in adverse event rates in randomized controlled trials
-
19013761 10.1016/j.jclinepi.2008.08.005 Epub 2008/11/18
-
Tsang R, Colley L, Lynd LD. Inadequate statistical power to detect clinically significant differences in adverse event rates in randomized controlled trials. J Clin Epidemiol. 2009;62(6):609-16. Epub 2008/11/18.
-
(2009)
J Clin Epidemiol
, vol.62
, Issue.6
, pp. 609-616
-
-
Tsang, R.1
Colley, L.2
Lynd, L.D.3
-
29
-
-
0037157603
-
Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: First results of the ATAC randomised trial
-
12090977 10.1016/S0140-6736(02)09088-8 1:CAS:528:DC%2BD38XkslGhsLY%3D Epub 2002/07/02
-
Baum M, Budzar AU, Cuzick J, Forbes J, Houghton JH, Klijn JG, et al. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet. 2002;359(9324):2131-9. Epub 2002/07/02.
-
(2002)
Lancet
, vol.359
, Issue.9324
, pp. 2131-2139
-
-
Baum, M.1
Budzar, A.U.2
Cuzick, J.3
Forbes, J.4
Houghton, J.H.5
Klijn, J.G.6
-
30
-
-
84877921736
-
-
Administration. FaD [cited 2012 January 20th]
-
Administration. FaD. Anastrozole: Full Prescribing Information. [cited 2012 January 20th]; Available at: http://www.accessdata.fda.gov/drugsatfda-docs/ label/2009/020541s024s025lbl.pdf.
-
Anastrozole: Full Prescribing Information
-
-
-
31
-
-
79958036418
-
Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer
-
21642684 10.1001/jama.2011.769 1:CAS:528:DC%2BC3MXntlOht70%3D Epub 2011/06/07
-
Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA. 2011;305(22):2320-6. Epub 2011/06/07.
-
(2011)
JAMA
, vol.305
, Issue.22
, pp. 2320-2326
-
-
Kesselheim, A.S.1
Myers, J.A.2
Avorn, J.3
-
32
-
-
48749103879
-
Adverse event detection in drug development: Recommendations and obligations beyond phase 3
-
18556607 10.2105/AJPH.2007.124537 Epub 2008/06/17
-
Berlin JA, Glasser SC, Ellenberg SS. Adverse event detection in drug development: recommendations and obligations beyond phase 3. Am J Public Health. 2008;98(8):1366-71. Epub 2008/06/17.
-
(2008)
Am J Public Health
, vol.98
, Issue.8
, pp. 1366-1371
-
-
Berlin, J.A.1
Glasser, S.C.2
Ellenberg, S.S.3
-
33
-
-
79960098048
-
New FDA regulation to improve safety reporting in clinical trials
-
21651388 10.1056/NEJMp1103464 1:CAS:528:DC%2BC3MXovVaru7w%3D Epub 2011/06/10
-
Sherman RB, Woodcock J, Norden J, Grandinetti C, Temple RJ. New FDA regulation to improve safety reporting in clinical trials. New Engl J Med. 2011;365(1):3-5. Epub 2011/06/10.
-
(2011)
New Engl J Med
, vol.365
, Issue.1
, pp. 3-5
-
-
Sherman, R.B.1
Woodcock, J.2
Norden, J.3
Grandinetti, C.4
Temple, R.J.5
-
34
-
-
0003032377
-
Estimating costs in cost-effectiveness analysis
-
M. Gold J.E. Siegel M.C. Weinstein L. Russell (eds) Oxford University Press New York
-
Luce BR, Manning WG, Siegel JE, Lipscomb J. Estimating costs in cost-effectiveness analysis. In: Gold M, Siegel JE, Weinstein MC, Russell L, editors. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.
-
(1996)
Cost-effectiveness in Health and Medicine
-
-
Luce, B.R.1
Manning, W.G.2
Siegel, J.E.3
Lipscomb, J.4
|