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Results: 1 to 20 of 232

1.

Regulatory perspectives on data monitoring.

O'Neill RT.

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

PMID:
12325099
[PubMed - indexed for MEDLINE]
2.

Regulatory perspectives on data safety monitoring boards: protecting the integrity of data.

Hemmings R, Day S.

Drug Saf. 2004;27(1):1-6.

PMID:
14720083
[PubMed - indexed for MEDLINE]
3.

Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership?

Ellenberg SS, George SL.

Stat Med. 2004 May 30;23(10):1503-5.

PMID:
15122727
[PubMed - indexed for MEDLINE]
4.

Clinical trials bureaucracy: unintended consequences of well-intentioned policy.

Califf RM.

Clin Trials. 2006;3(6):496-502.

PMID:
17170032
[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.

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
[PubMed - indexed for MEDLINE]
7.

Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.

Rockhold FW, Enas GG.

Stat Med. 1993 Mar;12(5-6):471-9. Review.

PMID:
8493425
[PubMed - indexed for MEDLINE]
8.

Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation.

Psaty BM, Kronmal RA.

JAMA. 2008 Apr 16;299(15):1813-7. doi: 10.1001/jama.299.15.1813.

PMID:
18413875
[PubMed - indexed for MEDLINE]
9.

Issues in regulatory guidelines for data monitoring committees.

DeMets D, Califf R, Dixon D, Ellenberg S, Fleming T, Held P, Julian D, Kaplan R, Levine R, Neaton J, Packer M, Pocock S, Rockhold F, Seto B, Siegel J, Snapinn S, Stump D, Temple R, Whitley R.

Clin Trials. 2004;1(2):162-9. Review.

PMID:
16281888
[PubMed - indexed for MEDLINE]
10.

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

Wilhelmsen L.

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

PMID:
12325098
[PubMed - indexed for MEDLINE]
11.

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

Lilienfeld DE.

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

PMID:
15170767
[PubMed - indexed for MEDLINE]
12.

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health.

Health Qual Life Outcomes. 2006 Oct 11;4:79.

PMID:
17034633
[PubMed - indexed for MEDLINE]
Free PMC Article
13.

The independent statistician for data monitoring committees.

DeMets DL, Fleming TR.

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

PMID:
15122729
[PubMed - indexed for MEDLINE]
14.

[Assessment of SUSARs. Clinical evaluation of single cases in terms of regulatory requirements].

Wroblewski H, Schmickler M.

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2005 Apr;48(4):459-63. German.

PMID:
15830258
[PubMed - indexed for MEDLINE]
15.

The other side of clinical trial monitoring; assuring data quality and procedural adherence.

Williams GW.

Clin Trials. 2006;3(6):530-7. Review.

PMID:
17170037
[PubMed - indexed for MEDLINE]
16.

Multicentre trials: a US regulatory perspective.

Anello C, O'Neill RT, Dubey S.

Stat Methods Med Res. 2005 Jun;14(3):303-18.

PMID:
15969305
[PubMed - indexed for MEDLINE]
17.

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
[PubMed - indexed for MEDLINE]
18.

Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report.

Coons SJ, Gwaltney CJ, Hays RD, Lundy JJ, Sloan JA, Revicki DA, Lenderking WR, Cella D, Basch E; ISPOR ePRO Task Force.

Value Health. 2009 Jun;12(4):419-29. doi: 10.1111/j.1524-4733.2008.00470.x. Epub 2008 Nov 11.

PMID:
19900250
[PubMed - indexed for MEDLINE]
19.

Policy developments in regulatory approval.

Temple R.

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

PMID:
12325110
[PubMed - indexed for MEDLINE]
20.

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.

PMID:
12184298
[PubMed - indexed for MEDLINE]
Free Article

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