264 related articles for article (PubMed ID: 12325099)
1. Regulatory perspectives on data monitoring.
O'Neill RT
Stat Med; 2002 Oct; 21(19):2831-42. PubMed ID: 12325099
[TBL] [Abstract][Full Text] [Related]
2. Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership?
Ellenberg SS; George SL
Stat Med; 2004 May; 23(10):1503-5. PubMed ID: 15122727
[TBL] [Abstract][Full Text] [Related]
3. Clinical trials bureaucracy: unintended consequences of well-intentioned policy.
Califf RM
Clin Trials; 2006; 3(6):496-502. PubMed ID: 17170032
[TBL] [Abstract][Full Text] [Related]
4. Role of the Data and Safety Monitoring Committee (DSMC).
Wilhelmsen L
Stat Med; 2002 Oct; 21(19):2823-9. PubMed ID: 12325098
[TBL] [Abstract][Full Text] [Related]
5. Pharmacoepidemiology 101: data monitoring committees in the post-marketing approval setting.
Lilienfeld DE
Pharmacoepidemiol Drug Saf; 2004 Jun; 13(6):381-5. PubMed ID: 15170767
[TBL] [Abstract][Full Text] [Related]
6. The independent statistician for data monitoring committees.
DeMets DL; Fleming TR
Stat Med; 2004 May; 23(10):1513-7. PubMed ID: 15122729
[TBL] [Abstract][Full Text] [Related]
7. The other side of clinical trial monitoring; assuring data quality and procedural adherence.
Williams GW
Clin Trials; 2006; 3(6):530-7. PubMed ID: 17170037
[TBL] [Abstract][Full Text] [Related]
8. Policy developments in regulatory approval.
Temple R
Stat Med; 2002 Oct; 21(19):2939-48. PubMed ID: 12325110
[TBL] [Abstract][Full Text] [Related]
9. The FDA's drug review process: ensuring drugs are safe and effective.
Meadows M
FDA Consum; 2002; 36(4):19-24. PubMed ID: 12184298
[No Abstract] [Full Text] [Related]
10. The FDA's new oncology office.
Pazdur R
Clin Adv Hematol Oncol; 2005 Aug; 3(8):612-3. PubMed ID: 16167044
[No Abstract] [Full Text] [Related]
11. What is the appropriate role of the trial statistician in preparing and presenting interim findings to an independent Data Monitoring Committee in the U.S. Cancer Cooperative Group setting?
Bryant J
Stat Med; 2004 May; 23(10):1507-11. PubMed ID: 15122728
[TBL] [Abstract][Full Text] [Related]
12. 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. PubMed ID: 17715246
[TBL] [Abstract][Full Text] [Related]
13. 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. PubMed ID: 22318615
[TBL] [Abstract][Full Text] [Related]
14. Conflicts of interest in data monitoring of industry versus publicly financed clinical trials.
Lachin JM
Stat Med; 2004 May; 23(10):1519-21. PubMed ID: 15122730
[TBL] [Abstract][Full Text] [Related]
15. United States Food and Drug Administration approval summary: bortezomib for the treatment of progressive multiple myeloma after one prior therapy.
Kane RC; Farrell AT; Sridhara R; Pazdur R
Clin Cancer Res; 2006 May; 12(10):2955-60. PubMed ID: 16707588
[TBL] [Abstract][Full Text] [Related]
16. Original research: Intravenous ribavirin--review of the FDA's Emergency Investigational New Drug Database (1997-2008) and literature review.
Riner A; Chan-Tack KM; Murray JS
Postgrad Med; 2009 May; 121(3):139-46. PubMed ID: 19491552
[TBL] [Abstract][Full Text] [Related]
17. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2008 Jul; 73(136):40453-63. PubMed ID: 18850678
[TBL] [Abstract][Full Text] [Related]
18. Specific barriers to the conduct of randomized trials.
Duley L; Antman K; Arena J; Avezum A; Blumenthal M; Bosch J; Chrolavicius S; Li T; Ounpuu S; Perez AC; Sleight P; Svard R; Temple R; Tsouderous Y; Yunis C; Yusuf S
Clin Trials; 2008; 5(1):40-8. PubMed ID: 18283079
[TBL] [Abstract][Full Text] [Related]
19. FDA attempting to overcome major roadblocks in monitoring drug safety.
Zielinski SL
J Natl Cancer Inst; 2005 Jun; 97(12):872-3. PubMed ID: 15956645
[No Abstract] [Full Text] [Related]
20. Futility approaches to interim monitoring by data monitoring committees.
Demets DL
Clin Trials; 2006; 3(6):522-9. PubMed ID: 17170036
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
