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Results: 1 to 20 of 120

1.

Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop.

Coffey CS, Levin B, Clark C, Timmerman C, Wittes J, Gilbert P, Harris S.

Clin Trials. 2012 Dec;9(6):671-80. doi: 10.1177/1740774512461859.

PMID:
23250942
[PubMed - indexed for MEDLINE]
2.

Adaptive clinical trials: progress and challenges.

Coffey CS, Kairalla JA.

Drugs R D. 2008;9(4):229-42. Review.

PMID:
18588354
[PubMed - indexed for MEDLINE]
3.

Review of draft FDA adaptive design guidance.

Cook T, DeMets DL.

J Biopharm Stat. 2010 Nov;20(6):1132-42. doi: 10.1080/10543406.2010.514455. Review.

PMID:
21058109
[PubMed - indexed for MEDLINE]
4.

Summary of NIH Medical-Surgical Emergency Research Roundtable held on April 30 to May 1, 2009.

Kaji AH, Lewis RJ, Beavers-May T, Berg R, Bulger E, Cairns C, Callaway C, Camargo CA Jr, Carcillo J, DeBiasi R, Diaz T, Ducharme F, Glickman S, Heilpern K, Hickey R, Hoek TV, Hollander J, Janson S, Jurkovich G, Kellermann A, Kingsmore S, Kline J, Kuppermann N, Lowe R, McLario D, Nathanson L, Nichol G, Peitzman A, Richardson L, Sanders A, Shah M, Shapiro N, Silverman R, Than M, Wilber S, Yealy DM; Roundtable External Participants and Roundtable Steering Committee and Federal Participants.

Ann Emerg Med. 2010 Nov;56(5):522-37. doi: 10.1016/j.annemergmed.2010.03.014.

PMID:
21036293
[PubMed - indexed for MEDLINE]
5.

Issues in data monitoring and interim analysis of trials.

Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH, Elbourne DR, McLeer SK, Parmar MK, Pocock SJ, Spiegelhalter DJ, Sydes MR, Walker AE, Wallace SA; DAMOCLES study group.

Health Technol Assess. 2005 Mar;9(7):1-238, iii-iv. Review.

PMID:
15763038
[PubMed - indexed for MEDLINE]
Free Article
6.

An overview of the optimal planning, design, and conduct of phase I studies of new therapeutics.

LoRusso PM, Boerner SA, Seymour L.

Clin Cancer Res. 2010 Mar 15;16(6):1710-8. doi: 10.1158/1078-0432.CCR-09-1993. Epub 2010 Mar 9. Review.

PMID:
20215546
[PubMed - indexed for MEDLINE]
Free Article
7.

NIH-FDA Analgesic Drug Development Workshop: translating scientific advances into improved pain relief.

Dionne RA, Witter J.

Clin J Pain. 2003 May-Jun;19(3):139-47. Review.

PMID:
12792552
[PubMed - indexed for MEDLINE]
8.

Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatrics Formulation Initiative: proceedings from the Second Workshop on Pediatric Formulations.

Giacoia GP, Taylor-Zapata P, Zajicek A.

Clin Ther. 2012 Nov;34(11):S1-10. doi: 10.1016/j.clinthera.2012.09.013.

PMID:
23149008
[PubMed - indexed for MEDLINE]
9.

An overview of statistical approaches for adaptive designs and design modifications.

Schäfer H, Timmesfeld N, Müller HH.

Biom J. 2006 Aug;48(4):507-20. Review.

PMID:
16972702
[PubMed - indexed for MEDLINE]
10.

Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study.

Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R, Entwistle V, Garcia J, Roberts I, Grant A, Grant A; STEPS group.

Health Technol Assess. 2007 Nov;11(48):iii, ix-105. Review.

PMID:
17999843
[PubMed - indexed for MEDLINE]
Free Article
11.

Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report.

Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, Cook J, Glick H, Liljas B, Petitti D, Reed S.

Value Health. 2005 Sep-Oct;8(5):521-33. Review.

PMID:
16176491
[PubMed - indexed for MEDLINE]
12.

Analgesia and anesthesia for neonates: study design and ethical issues.

Anand KJ, Aranda JV, Berde CB, Buckman S, Capparelli EV, Carlo WA, Hummel P, Lantos J, Johnston CC, Lehr VT, Lynn AM, Maxwell LG, Oberlander TF, Raju TN, Soriano SG, Taddio A, Walco GA.

Clin Ther. 2005 Jun;27(6):814-43. Review.

PMID:
16117988
[PubMed - indexed for MEDLINE]
13.

Adaptive trial designs: a review of barriers and opportunities.

Kairalla JA, Coffey CS, Thomann MA, Muller KE.

Trials. 2012 Aug 23;13:145. doi: 10.1186/1745-6215-13-145. Review.

PMID:
22917111
[PubMed - indexed for MEDLINE]
Free PMC Article
14.

Conflicts of interest in research involving human beings.

Greco D, Diniz NM.

J Int Bioethique. 2008 Mar-Jun;19(1-2):143-54, 202-3. Review.

PMID:
18664007
[PubMed - indexed for MEDLINE]
15.

Adaptive design methods in clinical trials - a review.

Chow SC, Chang M.

Orphanet J Rare Dis. 2008 May 2;3:11. doi: 10.1186/1750-1172-3-11. Review.

PMID:
18454853
[PubMed - indexed for MEDLINE]
Free PMC Article
16.

Drug metabolites in safety testing.

Baillie TA, Cayen MN, Fouda H, Gerson RJ, Green JD, Grossman SJ, Klunk LJ, LeBlanc B, Perkins DG, Shipley LA.

Toxicol Appl Pharmacol. 2002 Aug 1;182(3):188-96. Review.

PMID:
12229863
[PubMed - indexed for MEDLINE]
17.

A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies.

Sully BG, Julious SA, Nicholl J.

Trials. 2013 Jun 9;14:166. doi: 10.1186/1745-6215-14-166. Review.

PMID:
23758961
[PubMed - indexed for MEDLINE]
Free PMC Article
18.

Large clinical trials in epilepsy: funding by the NIH versus pharmaceutical industry.

Privitera M.

Epilepsy Res. 2006 Jan;68(1):52-6. Review.

PMID:
16377139
[PubMed - indexed for MEDLINE]
19.

Free-riding and the prisoner's dilemma: problems in funding economic analyses of phase III cancer clinical trials.

Bennett CL, Smith TJ, George SL, Hillner BE, Fleishman S, Niell HB.

J Clin Oncol. 1995 Sep;13(9):2457-63. Review.

PMID:
7545222
[PubMed - indexed for MEDLINE]
20.

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.

Eur J Cancer. 2012 Jun;48(9):1386-91. doi: 10.1016/j.ejca.2011.12.024. Epub 2012 Jan 24. Review.

PMID:
22281098
[PubMed - indexed for MEDLINE]
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