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Items: 1 to 20 of 25

1.

Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders.

by the CNS SUMMIT DATA QUALITY MONITORING WORKGROUP CORE MEMBERS, Daniel D, Kalali A, West M, Walling D, Hilt D, Engelhardt N, Alphs L, Loebel A, Vanover K, Atkinson S, Opler M, Sachs G, Nations K, Brady C.

Innov Clin Neurosci. 2016 Feb 1;13(1-2):27-33. eCollection 2016 Jan-Feb.

2.

Risk-Based Data Monitoring: Quality Control in Central Nervous System (CNS) Clinical Trials.

McNamara C, Engelhardt N, Potter W, Yavorsky C, Masotti M, Di Clemente G.

Ther Innov Regul Sci. 2018 Jan 1:2168479018774325. doi: 10.1177/2168479018774325. [Epub ahead of print]

PMID:
29758992
3.
4.

Central site monitoring: results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection.

Lindblad AS, Manukyan Z, Purohit-Sheth T, Gensler G, Okwesili P, Meeker-O'Connell A, Ball L, Marler JR.

Clin Trials. 2014 Apr;11(2):205-17. doi: 10.1177/1740774513508028. Epub 2013 Dec 2.

PMID:
24296321
5.

Development of guideline-based indicators for patient-centredness in fertility care: what patients add.

den Breejen EM, Nelen WL, Schol SF, Kremer JA, Hermens RP.

Hum Reprod. 2013 Apr;28(4):987-96. doi: 10.1093/humrep/det010. Epub 2013 Feb 14.

PMID:
23411619
6.

Guidelines, editors, pharma and the biological paradigm shift.

Singh AR, Singh SA.

Mens Sana Monogr. 2007 Jan;5(1):27-30. doi: 10.4103/0973-1229.32176.

7.

Blood pressure measurement in research.

Parati G, de Leeuw P, Illyes M, Julius S, Kuwajima I, Mallion JM, Ohtsuka K, Imai Y; 2001 Consensus Conference on Ambulatory Blood Pressure Monitoring participants.

Blood Press Monit. 2002 Feb;7(1):83-7. Review.

PMID:
12040251
8.

Inhaled corticosteroids in children with persistent asthma: effects on growth.

Zhang L, Prietsch SO, Ducharme FM.

Evid Based Child Health. 2014 Dec;9(4):829-930. doi: 10.1002/ebch.1988.

PMID:
25504972
9.

A statistical approach to central monitoring of data quality in clinical trials.

Venet D, Doffagne E, Burzykowski T, Beckers F, Tellier Y, Genevois-Marlin E, Becker U, Bee V, Wilson V, Legrand C, Buyse M.

Clin Trials. 2012 Dec;9(6):705-13. doi: 10.1177/1740774512447898. Epub 2012 Jun 8.

PMID:
22684241
10.

Development of a checklist of quality indicators for clinical trials in resource-limited countries: the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) experience.

Hanna M, Minga A, Fao P, Borand L, Diouf A, Mben JM, Gad RR, Anglaret X, Bazin B, Chene G; [Quali-PED] ANRS 12175 Study Group.

Clin Trials. 2013 Apr;10(2):300-18. doi: 10.1177/1740774512470765. Epub 2013 Jan 23.

PMID:
23345311
11.

What is causing the reduced drug-placebo difference in recent schizophrenia clinical trials and what can be done about it?

Kemp AS, Schooler NR, Kalali AH, Alphs L, Anand R, Awad G, Davidson M, Dubé S, Ereshefsky L, Gharabawi G, Leon AC, Lepine JP, Potkin SG, Vermeulen A.

Schizophr Bull. 2010 May;36(3):504-9. doi: 10.1093/schbul/sbn110. Epub 2008 Aug 22.

12.

Data monitoring boards in the pharmaceutical industry.

Herson J.

Stat Med. 1993 Mar;12(5-6):555-61; discussion 563.

PMID:
8493431
13.

Melding regulatory, pharmaceutical industry, and U.S. payer perspectives on improving approaches to heterogeneity of treatment effect in research and practice.

Willke RJ, Crown W, Del Aguila M, Cziraky MJ, Khan ZM, Migliori R.

Value Health. 2013 Sep-Oct;16(6 Suppl):S10-5. doi: 10.1016/j.jval.2013.06.006.

14.

Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials.

Brosteanu O, Houben P, Ihrig K, Ohmann C, Paulus U, Pfistner B, Schwarz G, Strenge-Hesse A, Zettelmeyer U.

Clin Trials. 2009 Dec;6(6):585-96. doi: 10.1177/1740774509347398. Epub 2009 Nov 6.

PMID:
19897532
15.

[A research roadmap for complementary and alternative medicine - what we need to know by 2020].

Fischer F, Lewith G, Witt CM, Linde K, von Ammon K, Cardini F, Falkenberg T, Fønnebø V, Johannessen H, Reiter B, Uehleke B, Weidenhammer W, Brinkhaus B.

Forsch Komplementmed. 2014;21(2):e1-16. doi: 10.1159/000360744. Epub 2014 Mar 24.

16.

The clinical effectiveness and cost-effectiveness of primary human papillomavirus cervical screening in England: extended follow-up of the ARTISTIC randomised trial cohort through three screening rounds.

C Kitchener H, Canfell K, Gilham C, Sargent A, Roberts C, Desai M, Peto J.

Health Technol Assess. 2014 Apr;18(23):1-196. doi: 10.3310/hta18230.

17.

A critical synopsis of the diagnostic and screening radiology outcomes literature.

Blackmore CC, Black WC, Jarvik JG, Langlotz CP.

Acad Radiol. 1999 Jan;6 Suppl 1:S8-18.

PMID:
9891161
18.

Adaptive design clinical trials and trial logistics models in CNS drug development.

Wang SJ, Hung HM, O'Neill R.

Eur Neuropsychopharmacol. 2011 Feb;21(2):159-66. doi: 10.1016/j.euroneuro.2010.09.003. Epub 2010 Oct 8. Review.

PMID:
20933373
19.

Evidence based evaluation of immuno-coagulatory interventions in critical care.

Afshari A.

Dan Med Bull. 2011 Sep;58(9):B4316. Review.

PMID:
21893014
20.

Association between pacifier use and breast-feeding, sudden infant death syndrome, infection and dental malocclusion.

Callaghan A, Kendall G, Lock C, Mahony A, Payne J, Verrier L.

Int J Evid Based Healthc. 2005 Jul;3(6):147-67. doi: 10.1111/j.1479-6988.2005.00024.x.

PMID:
21631747

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