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Adaptive design method based on sum of p-values.

Statistics in medicine

Chang M.
PMID: 17133651
Stat Med. 2007 Jun 30;26(14):2772-84. doi: 10.1002/sim.2755.

Bauer and Kohne proposed an adaptive design using Fisher's combination of independent p-values based on subsamples from different stages (Biometrics 1994; 50(4):1029-1041). Their method provides great flexibility in the selection of statistical methods for hypothesis testing of subsamples. However,...

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Chang M. Adaptive design method based on sum of p-values. Stat Med. 2007;26(14):2772-84doi: 10.1002/sim.2755.
Chang, M. (2007). Adaptive design method based on sum of p-values. Statistics in medicine, 26(14), 2772-84. https://doi.org/10.1002/sim.2755
Chang, Mark. "Adaptive design method based on sum of p-values." Statistics in medicine vol. 26,14 (2007): 2772-84. doi: https://doi.org/10.1002/sim.2755
Chang M. Adaptive design method based on sum of p-values. Stat Med. 2007 Jun 30;26(14):2772-84. doi: 10.1002/sim.2755. PMID: 17133651.
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Some issues with composite endpoints in clinical trials.

Fundamental & clinical pharmacology

Chi GY.
PMID: 16313272
Fundam Clin Pharmacol. 2005 Dec;19(6):609-19. doi: 10.1111/j.1472-8206.2005.00370.x.

This article discusses some important issues that may arise in the current usage of composite endpoints as primary endpoints for demonstrating the efficacy of new drugs in clinical trials. The discussion focuses on time-to-event composite endpoints. Issues discussed include...

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Chi GY. Some issues with composite endpoints in clinical trials. Fundam Clin Pharmacol. 2005;19(6):609-19doi: 10.1111/j.1472-8206.2005.00370.x.
Chi, G. Y. (2005). Some issues with composite endpoints in clinical trials. Fundamental & clinical pharmacology, 19(6), 609-19. https://doi.org/10.1111/j.1472-8206.2005.00370.x
Chi, George Y H. "Some issues with composite endpoints in clinical trials." Fundamental & clinical pharmacology vol. 19,6 (2005): 609-19. doi: https://doi.org/10.1111/j.1472-8206.2005.00370.x
Chi GY. Some issues with composite endpoints in clinical trials. Fundam Clin Pharmacol. 2005 Dec;19(6):609-19. doi: 10.1111/j.1472-8206.2005.00370.x. PMID: 16313272.
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Multiplicity and flexibility in clinical trials.

Pharmaceutical statistics

Brannath W, Koenig F, Bauer P.
PMID: 17674349
Pharm Stat. 2007 Jul-Sep;6(3):205-16. doi: 10.1002/pst.302.

Flexible designs offer a large amount of flexibility in clinical trials with control of the type I error rate. This allows the combination of trials from different clinical phases of a drug development process. Such combinations require designs where...

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Brannath W, Koenig F, Bauer P. Multiplicity and flexibility in clinical trials. Pharm Stat. 2007;6(3):205-16doi: 10.1002/pst.302.
Brannath, W., Koenig, F., & Bauer, P. (2007). Multiplicity and flexibility in clinical trials. Pharmaceutical statistics, 6(3), 205-16. https://doi.org/10.1002/pst.302
Brannath, Werner, et al. "Multiplicity and flexibility in clinical trials." Pharmaceutical statistics vol. 6,3 (2007): 205-16. doi: https://doi.org/10.1002/pst.302
Brannath W, Koenig F, Bauer P. Multiplicity and flexibility in clinical trials. Pharm Stat. 2007 Jul-Sep;6(3):205-16. doi: 10.1002/pst.302. PMID: 17674349.
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Outcomes, outcomes, every where, nor any stop to think?.

Journal of general internal medicine

West CP.
PMID: 21901493
J Gen Intern Med. 2011 Nov;26(11):1239-40. doi: 10.1007/s11606-011-1852-0.

No abstract available.

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West CP. Outcomes, outcomes, every where, nor any stop to think?. J Gen Intern Med. 2011;26(11):1239-40doi: 10.1007/s11606-011-1852-0.
West, C. P. (2011). Outcomes, outcomes, every where, nor any stop to think?. Journal of general internal medicine, 26(11), 1239-40. https://doi.org/10.1007/s11606-011-1852-0
West, Colin P. "Outcomes, outcomes, every where, nor any stop to think?." Journal of general internal medicine vol. 26,11 (2011): 1239-40. doi: https://doi.org/10.1007/s11606-011-1852-0
West CP. Outcomes, outcomes, every where, nor any stop to think?. J Gen Intern Med. 2011 Nov;26(11):1239-40. doi: 10.1007/s11606-011-1852-0. PMID: 21901493; PMCID: PMC3208459.
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Considerations in the development of drugs to treat sarcopenia.

Journal of the American Geriatrics Society

Brass EP, Sietsema KE.
PMID: 21361879
J Am Geriatr Soc. 2011 Mar;59(3):530-5. doi: 10.1111/j.1532-5415.2010.03285.x. Epub 2011 Mar 01.

Sarcopenia describes reduced skeletal muscle mass and impaired muscle function associated with aging and with a variety of chronic diseases prevalent in the aging population. With increasing understanding of the molecular pathways participating in the structural and functional changes...

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Brass EP, Sietsema KE. Considerations in the development of drugs to treat sarcopenia. J Am Geriatr Soc. 2011;59(3):530-5doi: 10.1111/j.1532-5415.2010.03285.x.
Brass, E. P., & Sietsema, K. E. (2011). Considerations in the development of drugs to treat sarcopenia. Journal of the American Geriatrics Society, 59(3), 530-5. https://doi.org/10.1111/j.1532-5415.2010.03285.x
Brass, Eric P, and Sietsema, Kathy E. "Considerations in the development of drugs to treat sarcopenia." Journal of the American Geriatrics Society vol. 59,3 (2011): 530-5. doi: https://doi.org/10.1111/j.1532-5415.2010.03285.x
Brass EP, Sietsema KE. Considerations in the development of drugs to treat sarcopenia. J Am Geriatr Soc. 2011 Mar;59(3):530-5. doi: 10.1111/j.1532-5415.2010.03285.x. Epub 2011 Mar 01. PMID: 21361879.
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Complete Versus culprit-Lesion only PRimary PCI Trial (CVLPRIT): a multicentre trial testing management strategies when multivessel disease is detected at the time of primary PCI: rationale and design.

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

Kelly DJ, McCann GP, Blackman D, Curzen NP, Dalby M, Greenwood JP, Fairbrother K, Shipley L, Kelion A, Heatherington S, Khan JN, Nazir S, Alahmar A, Flather M, Swanton H, Schofield P, Gunning M, Hall R, Gershlick AH.
PMID: 23425543
EuroIntervention. 2013 Feb 22;8(10):1190-8. doi: 10.4244/EIJV8I10A183.

AIMS: Primary percutaneous coronary intervention (PPCI) is the preferred strategy for acute ST-segment elevation myocardial infarction (STEMI), with evidence of improved clinical outcomes compared to fibrinolytic therapy. However, there is no consensus on how best to manage multivessel coronary...

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Kelly DJ, McCann GP, Blackman D, et al. Complete Versus culprit-Lesion only PRimary PCI Trial (CVLPRIT): a multicentre trial testing management strategies when multivessel disease is detected at the time of primary PCI: rationale and design. EuroIntervention. 2013;8(10):1190-8doi: 10.4244/EIJV8I10A183.
Kelly, D. J., McCann, G. P., Blackman, D., Curzen, N. P., Dalby, M., Greenwood, J. P., Fairbrother, K., Shipley, L., Kelion, A., Heatherington, S., Khan, J. N., Nazir, S., Alahmar, A., Flather, M., Swanton, H., Schofield, P., Gunning, M., Hall, R., & Gershlick, A. H. (2013). Complete Versus culprit-Lesion only PRimary PCI Trial (CVLPRIT): a multicentre trial testing management strategies when multivessel disease is detected at the time of primary PCI: rationale and design. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 8(10), 1190-8. https://doi.org/10.4244/EIJV8I10A183
Kelly, Damian J, et al. "Complete Versus culprit-Lesion only PRimary PCI Trial (CVLPRIT): a multicentre trial testing management strategies when multivessel disease is detected at the time of primary PCI: rationale and design." EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology vol. 8,10 (2013): 1190-8. doi: https://doi.org/10.4244/EIJV8I10A183
Kelly DJ, McCann GP, Blackman D, Curzen NP, Dalby M, Greenwood JP, Fairbrother K, Shipley L, Kelion A, Heatherington S, Khan JN, Nazir S, Alahmar A, Flather M, Swanton H, Schofield P, Gunning M, Hall R, Gershlick AH. Complete Versus culprit-Lesion only PRimary PCI Trial (CVLPRIT): a multicentre trial testing management strategies when multivessel disease is detected at the time of primary PCI: rationale and design. EuroIntervention. 2013 Feb 22;8(10):1190-8. doi: 10.4244/EIJV8I10A183. PMID: 23425543.
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Clinical trial design in head and neck cancer: what has the oncologist learned?.

The Lancet. Oncology

Adelstein DJ.
PMID: 22748271
Lancet Oncol. 2012 Jul;13(7):e318-23. doi: 10.1016/S1470-2045(12)70119-5. Epub 2012 Jun 28.

Chemotherapy has assumed an important role in multidisciplinary management of patients with head and neck cancer. Much recent progress is attributable to successful design and careful implementation of clinical trials. In addition to showing the efficacy of chemotherapy, trials...

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Adelstein DJ. Clinical trial design in head and neck cancer: what has the oncologist learned?. Lancet Oncol. 2012;13(7):e318-23doi: 10.1016/S1470-2045(12)70119-5.
Adelstein, D. J. (2012). Clinical trial design in head and neck cancer: what has the oncologist learned?. The Lancet. Oncology, 13(7), e318-23. https://doi.org/10.1016/S1470-2045(12)70119-5
Adelstein, David J. "Clinical trial design in head and neck cancer: what has the oncologist learned?." The Lancet. Oncology vol. 13,7 (2012): e318-23. doi: https://doi.org/10.1016/S1470-2045(12)70119-5
Adelstein DJ. Clinical trial design in head and neck cancer: what has the oncologist learned?. Lancet Oncol. 2012 Jul;13(7):e318-23. doi: 10.1016/S1470-2045(12)70119-5. Epub 2012 Jun 28. PMID: 22748271.
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A case study of an adaptive design for a clinical trial with 2 doses and 2 endpoints in a rare disease area.

Pharmaceutical statistics

Quan H, Xu Y, Chen Y, Gao L, Chen X.
PMID: 30221446
Pharm Stat. 2018 Nov;17(6):797-810. doi: 10.1002/pst.1902. Epub 2018 Sep 16.

Patient recruitment is challenging in rare disease clinical trials. To save time and resources, an inferential seamless phase II/III clinical trial design is considered for a clinical trial in a rare disease area. In particular, 2 doses compared to...

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Quan H, Xu Y, Chen Y, et al. A case study of an adaptive design for a clinical trial with 2 doses and 2 endpoints in a rare disease area. Pharm Stat. 2018;17(6):797-810doi: 10.1002/pst.1902.
Quan, H., Xu, Y., Chen, Y., Gao, L., & Chen, X. (2018). A case study of an adaptive design for a clinical trial with 2 doses and 2 endpoints in a rare disease area. Pharmaceutical statistics, 17(6), 797-810. https://doi.org/10.1002/pst.1902
Quan, Hui, et al. "A case study of an adaptive design for a clinical trial with 2 doses and 2 endpoints in a rare disease area." Pharmaceutical statistics vol. 17,6 (2018): 797-810. doi: https://doi.org/10.1002/pst.1902
Quan H, Xu Y, Chen Y, Gao L, Chen X. A case study of an adaptive design for a clinical trial with 2 doses and 2 endpoints in a rare disease area. Pharm Stat. 2018 Nov;17(6):797-810. doi: 10.1002/pst.1902. Epub 2018 Sep 16. PMID: 30221446.
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The Value of Progression-Free Survival as a Treatment End Point Among Patients With Advanced Cancer: A Systematic Review and Qualitative Assessment of the Literature.

JAMA oncology

Raphael MJ, Robinson A, Booth CM, O'Donnell J, Palmer M, Eisenhauer E, Brundage M.
PMID: 31556921
JAMA Oncol. 2019 Dec 01;5(12):1779-1789. doi: 10.1001/jamaoncol.2019.3338.

IMPORTANCE: It is unclear whether patients with advanced cancer value surrogate end points, particularly progression-free survival (PFS). Despite this uncertainty, surrogate end points form the basis of regulatory approval for the majority of new cancer treatments.OBJECTIVE: To summarize and...

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Raphael MJ, Robinson A, Booth CM, et al. The Value of Progression-Free Survival as a Treatment End Point Among Patients With Advanced Cancer: A Systematic Review and Qualitative Assessment of the Literature. JAMA Oncol. 2019;5(12):1779-1789doi: 10.1001/jamaoncol.2019.3338.
Raphael, M. J., Robinson, A., Booth, C. M., O'Donnell, J., Palmer, M., Eisenhauer, E., & Brundage, M. (2019). The Value of Progression-Free Survival as a Treatment End Point Among Patients With Advanced Cancer: A Systematic Review and Qualitative Assessment of the Literature. JAMA oncology, 5(12), 1779-1789. https://doi.org/10.1001/jamaoncol.2019.3338
Raphael, Michael J, et al. "The Value of Progression-Free Survival as a Treatment End Point Among Patients With Advanced Cancer: A Systematic Review and Qualitative Assessment of the Literature." JAMA oncology vol. 5,12 (2019): 1779-1789. doi: https://doi.org/10.1001/jamaoncol.2019.3338
Raphael MJ, Robinson A, Booth CM, O'Donnell J, Palmer M, Eisenhauer E, Brundage M. The Value of Progression-Free Survival as a Treatment End Point Among Patients With Advanced Cancer: A Systematic Review and Qualitative Assessment of the Literature. JAMA Oncol. 2019 Dec 01;5(12):1779-1789. doi: 10.1001/jamaoncol.2019.3338. PMID: 31556921.
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Increasing the use of mobile technology-derived endpoints in clinical trials.

Clinical trials (London, England)

Herrington WG, Goldsack JC, Landray MJ.
PMID: 29400066
Clin Trials. 2018 Jun;15(3):313-315. doi: 10.1177/1740774518755393. Epub 2018 Feb 05.

No abstract available.

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Herrington WG, Goldsack JC, Landray MJ. Increasing the use of mobile technology-derived endpoints in clinical trials. Clin Trials. 2018;15(3):313-315doi: 10.1177/1740774518755393.
Herrington, W. G., Goldsack, J. C., & Landray, M. J. (2018). Increasing the use of mobile technology-derived endpoints in clinical trials. Clinical trials (London, England), 15(3), 313-315. https://doi.org/10.1177/1740774518755393
Herrington, William G, et al. "Increasing the use of mobile technology-derived endpoints in clinical trials." Clinical trials (London, England) vol. 15,3 (2018): 313-315. doi: https://doi.org/10.1177/1740774518755393
Herrington WG, Goldsack JC, Landray MJ. Increasing the use of mobile technology-derived endpoints in clinical trials. Clin Trials. 2018 Jun;15(3):313-315. doi: 10.1177/1740774518755393. Epub 2018 Feb 05. PMID: 29400066; PMCID: PMC5992831.
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Methods for the analysis of multiple endpoints in small populations: A review.

Journal of biopharmaceutical statistics

Ristl R, Urach S, Rosenkranz G, Posch M.
PMID: 29985752
J Biopharm Stat. 2019;29(1):1-29. doi: 10.1080/10543406.2018.1489402. Epub 2018 Jul 09.

While current guidelines generally recommend single endpoints for primary analyses of confirmatory clinical trials, it is recognized that certain settings require inference on multiple endpoints for comprehensive conclusions on treatment effects. Furthermore, combining treatment effect estimates from several outcome...

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Ristl R, Urach S, Rosenkranz G, et al. Methods for the analysis of multiple endpoints in small populations: A review. J Biopharm Stat. 2018;29(1):1-29doi: 10.1080/10543406.2018.1489402.
Ristl, R., Urach, S., Rosenkranz, G., & Posch, M. (2019). Methods for the analysis of multiple endpoints in small populations: A review. Journal of biopharmaceutical statistics, 29(1), 1-29. https://doi.org/10.1080/10543406.2018.1489402
Ristl, Robin, et al. "Methods for the analysis of multiple endpoints in small populations: A review." Journal of biopharmaceutical statistics vol. 29,1 (2019): 1-29. doi: https://doi.org/10.1080/10543406.2018.1489402
Ristl R, Urach S, Rosenkranz G, Posch M. Methods for the analysis of multiple endpoints in small populations: A review. J Biopharm Stat. 2019;29(1):1-29. doi: 10.1080/10543406.2018.1489402. Epub 2018 Jul 09. PMID: 29985752.
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On sample size determination in multi-armed confirmatory adaptive designs.

Journal of biopharmaceutical statistics

Wassmer G.
PMID: 21516570
J Biopharm Stat. 2011 Jul;21(4):802-17. doi: 10.1080/10543406.2011.551336.

An important application of confirmatory adaptive designs is the data-driven selection of treatment arms in multi-armed trials. A general methodology for adaptive designs is based on the combination testing principle. Using this principle, selection of treatment arms in multi-armed...

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Wassmer G. On sample size determination in multi-armed confirmatory adaptive designs. J Biopharm Stat. 2011;21(4):802-17doi: 10.1080/10543406.2011.551336.
Wassmer, G. (2011). On sample size determination in multi-armed confirmatory adaptive designs. Journal of biopharmaceutical statistics, 21(4), 802-17. https://doi.org/10.1080/10543406.2011.551336
Wassmer, Gernot. "On sample size determination in multi-armed confirmatory adaptive designs." Journal of biopharmaceutical statistics vol. 21,4 (2011): 802-17. doi: https://doi.org/10.1080/10543406.2011.551336
Wassmer G. On sample size determination in multi-armed confirmatory adaptive designs. J Biopharm Stat. 2011 Jul;21(4):802-17. doi: 10.1080/10543406.2011.551336. PMID: 21516570.
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Showing 1 to 12 of 72 entries