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Items: 1 to 20 of 243

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
2.

Adaptive clinical trials: progress and challenges.

Coffey CS, Kairalla JA.

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

PMID:
18588354
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
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
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.

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.

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
8.
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
10.

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
11.

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
12.

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.

13.

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
14.

Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency.

Elsäßer A, Regnstrom J, Vetter T, Koenig F, Hemmings RJ, Greco M, Papaluca-Amati M, Posch M.

Trials. 2014 Oct 2;15:383. doi: 10.1186/1745-6215-15-383. Review.

15.

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
16.

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
17.

Research on complementary and alternative medicine using randomized controlled trials.

Harlan WR Jr.

J Altern Complement Med. 2001;7 Suppl 1:S45-52. Review.

PMID:
11822635
18.

Innovative approaches to clinical development and trial design.

Orloff JJ, Stanski D.

Ann Ist Super Sanita. 2011;47(1):8-13. doi: 10.4415/ANN_11_01_03. Review.

19.

General practice-based clinical trials in Germany - a problem analysis.

Hummers-Pradier E, Bleidorn J, Schmiemann G, Joos S, Becker A, Altiner A, Chenot JF, Scherer M; German ‘Clinical Trials in German General Practice Network’.

Trials. 2012 Nov 8;13:205. doi: 10.1186/1745-6215-13-205. Review.

20.

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.

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