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Items: 1 to 20 of 225

1.

Regulatory perspectives on data monitoring.

O'Neill RT.

Stat Med. 2002 Oct 15;21(19):2831-42.

PMID:
12325099
2.
3.
4.

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.

5.

Some FDA perspectives on data monitoring in clinical trials in drug development.

O'Neill RT.

Stat Med. 1993 Mar;12(5-6):601-8; discussion 609-14.

PMID:
8493434
6.
7.

Role of the Data and Safety Monitoring Committee (DSMC).

Wilhelmsen L.

Stat Med. 2002 Oct 15;21(19):2823-9.

PMID:
12325098
8.

Pharmacoepidemiology 101: data monitoring committees in the post-marketing approval setting.

Lilienfeld DE.

Pharmacoepidemiol Drug Saf. 2004 Jun;13(6):381-5.

PMID:
15170767
9.

The independent statistician for data monitoring committees.

DeMets DL, Fleming TR.

Stat Med. 2004 May 30;23(10):1513-7.

PMID:
15122729
10.
11.

A model for the interim analysis process: a case study.

Delgado-Herrera L, Anbar D.

Control Clin Trials. 2003 Feb;24(1):51-65.

PMID:
12559642
12.

Policy developments in regulatory approval.

Temple R.

Stat Med. 2002 Oct 15;21(19):2939-48.

PMID:
12325110
13.

The FDA's drug review process: ensuring drugs are safe and effective.

Meadows M.

FDA Consum. 2002 Jul-Aug;36(4):19-24. No abstract available.

14.

The FDA's new oncology office.

Pazdur R.

Clin Adv Hematol Oncol. 2005 Aug;3(8):612-3. Review. No abstract available.

PMID:
16167044
16.

Monitoring and reporting of the Women's Health Initiative randomized hormone therapy trials.

Anderson GL, Kooperberg C, Geller N, Rossouw JE, Pettinger M, Prentice RL.

Clin Trials. 2007;4(3):207-17.

PMID:
17715246
17.

ICH E9 guideline 'Statistical principles for clinical trials': a case study.

Phillips A, Haudiquet V.

Stat Med. 2003 Jan 15;22(1):1-11; discussion 13-7.

PMID:
12486747
19.

The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it.

O'Neill RT, Temple R.

Clin Pharmacol Ther. 2012 Mar;91(3):550-4. doi: 10.1038/clpt.2011.340. Epub 2012 Feb 8.

PMID:
22318615
20.

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