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Inclusion of women in clinical trials.

Berlin JA, Ellenberg SS.

BMC Med. 2009 Oct 9;7:56.PMID: 19818115 [PubMed - in process]Related articlesFree article

Adverse event detection in drug development: recommendations and obligations beyond phase 3.

Berlin JA, Glasser SC, Ellenberg SS.

Am J Public Health. 2008 Aug;98(8):1366-71. Epub 2008 Jun 12.PMID: 18556607 [PubMed - indexed for MEDLINE]Related articles

Media coverage of the measles-mumps-rubella vaccine and autism controversy and its relationship to MMR immunization rates in the United States.

Smith MJ, Ellenberg SS, Bell LM, Rubin DM.

Pediatrics. 2008 Apr;121(4):e836-43.PMID: 18381512 [PubMed - indexed for MEDLINE]Related articlesFree article

Adjuvant therapy for gastric cancer: how negative results can help patients.

Ellenberg SS, Sun W.

J Natl Cancer Inst. 2007 Apr 18;99(8):580-2. No abstract available. PMID: 17440152 [PubMed - indexed for MEDLINE]Related articlesFree article

Marketing drugs too early in testing.

Begg CB, Brawley O, Califf RM, Demets DL, Ellenberg SS, Kaplan RS.

Science. 2006 Apr 14;312(5771):195. No abstract available. PMID: 16614197 [PubMed - indexed for MEDLINE]Related articles

Monitoring data on data monitoring.

Ellenberg SS.

Clin Trials. 2004 Feb;1(1):6-8. No abstract available. PMID: 16281457 [PubMed - indexed for MEDLINE]Related articles

Evaluating the safety of new vaccines: summary of a workshop.

Ellenberg SS, Foulkes MA, Midthun K, Goldenthal KL.

Am J Public Health. 2005 May;95(5):800-7.PMID: 15855455 [PubMed - indexed for MEDLINE]Related articlesFree article

A global perspective on vaccine safety and public health: the Global Advisory Committee on Vaccine Safety.

Folb PI, Bernatowska E, Chen R, Clemens J, Dodoo AN, Ellenberg SS, Farrington CP, John TJ, Lambert PH, Macdonald NE, Miller E, Salisbury D, Schmitt HJ, Siegrist CA, Wimalaratne O.

Am J Public Health. 2004 Nov;94(11):1926-31.PMID: 15514229 [PubMed - indexed for MEDLINE]Related articlesFree article

Homocysteine as a predictive factor for hip fracture in older persons.

Ellenberg SS, Orloff DG, Temple RJ.

N Engl J Med. 2004 Sep 2;351(10):1027-30; author reply 1027-30. No abstract available. PMID: 15352276 [PubMed - indexed for MEDLINE]Related articles

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]Related articles

Analytical, practical and regulatory issues in prevention studies.

Ellenberg SS.

Stat Med. 2004 Jan 30;23(2):297-303.PMID: 14716730 [PubMed - indexed for MEDLINE]Related articles

Are all monitoring boundaries equally ethical?

Ellenberg SS.

Control Clin Trials. 2003 Oct;24(5):585-8. No abstract available. PMID: 14500055 [PubMed - indexed for MEDLINE]Related articles

Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001.

Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT.

MMWR Surveill Summ. 2003 Jan 24;52(1):1-24. Erratum in: MMWR Morb Mortal Wkly Rep. 2003 Feb 14;52(06):113. PMID: 12825543 [PubMed - indexed for MEDLINE]Related articlesFree article

Scientific and ethical issues in the use of placebo and active controls in clinical trials.

Ellenberg SS.

J Bone Miner Res. 2003 Jun;18(6):1121-4. No abstract available. PMID: 12817767 [PubMed - indexed for MEDLINE]Related articles

Is the use of placebo controls ethically permissible in clinical trials of agents intended to reduce fractures in osteoporosis?

Brody BA, Dickey N, Ellenberg SS, Heaney RP, Levine RJ, O'Brien RL, Purtilo RB, Weijer C.

J Bone Miner Res. 2003 Jun;18(6):1105-9.PMID: 12817764 [PubMed - indexed for MEDLINE]Related articles

Monitoring the safety of vaccines: assessing the risks.

Ellenberg SS, Braun MM.

Drug Saf. 2002;25(3):145-52.PMID: 11945111 [PubMed - indexed for MEDLINE]Related articles

Pediatric deaths reported after vaccination: the utility of information obtained from parents.

Silvers LE, Varricchio FE, Ellenberg SS, Krueger CL, Wise RP, Salive ME.

Am J Prev Med. 2002 Apr;22(3):170-6.PMID: 11897461 [PubMed - indexed for MEDLINE]Related articles

Adverse event reports following vaccination for Lyme disease: December 1998-July 2000.

Lathrop SL, Ball R, Haber P, Mootrey GT, Braun MM, Shadomy SV, Ellenberg SS, Chen RT, Hayes EB.

Vaccine. 2002 Feb 22;20(11-12):1603-8.PMID: 11858868 [PubMed - indexed for MEDLINE]Related articles

Surrogate endpoints: the debate goes on.

Ellenberg SS.

Pharmacoepidemiol Drug Saf. 2001 Oct-Nov;10(6):493-6. No abstract available. PMID: 11828830 [PubMed - indexed for MEDLINE]Related articles

Safety considerations for new vaccine development.

Ellenberg SS.

Pharmacoepidemiol Drug Saf. 2001 Aug-Sep;10(5):411-5.PMID: 11802587 [PubMed - indexed for MEDLINE]Related articles

The epidemiology of fatalities reported to the vaccine adverse event reporting system 1990-1997.

Silvers LE, Ellenberg SS, Wise RP, Varricchio FE, Mootrey GT, Salive ME.

Pharmacoepidemiol Drug Saf. 2001 Jun-Jul;10(4):279-85.PMID: 11760487 [PubMed - indexed for MEDLINE]Related articles

Evaluating the safety of combination vaccines.

Ellenberg SS.

Clin Infect Dis. 2001 Dec 15;33 Suppl 4:S319-22. Review.PMID: 11709766 [PubMed - indexed for MEDLINE]Related articles

Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop.

De Gruttola VG, Clax P, DeMets DL, Downing GJ, Ellenberg SS, Friedman L, Gail MH, Prentice R, Wittes J, Zeger SL.

Control Clin Trials. 2001 Oct;22(5):485-502.PMID: 11578783 [PubMed - indexed for MEDLINE]Related articles

Independent data monitoring committees: rationale, operations and controversies.

Ellenberg SS.

Stat Med. 2001 Sep 15-30;20(17-18):2573-83.PMID: 11523070 [PubMed - indexed for MEDLINE]Related articles

Statistical approaches and policies for the operations of Data and Safety Monitoring Committees.

Califf RM, Ellenberg SS.

Am Heart J. 2001 Feb;141(2):301-5. Review. No abstract available. PMID: 11174347 [PubMed - indexed for MEDLINE]Related articles

Fraud is bad, studying fraud is hard.

Ellenberg SS.

Control Clin Trials. 2000 Oct;21(5):498-500. No abstract available. PMID: 11018566 [PubMed - indexed for MEDLINE]Related articles

Infant immunization with acellular pertussis vaccines in the United States: assessment of the first two years' data from the Vaccine Adverse Event Reporting System (VAERS).

Braun MM, Mootrey GT, Salive ME, Chen RT, Ellenberg SS.

Pediatrics. 2000 Oct;106(4):E51.PMID: 11015546 [PubMed - indexed for MEDLINE]Related articles

Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases.

Ellenberg SS, Temple R.

Ann Intern Med. 2000 Sep 19;133(6):464-70.PMID: 10975965 [PubMed - indexed for MEDLINE]Related articlesFree article

Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues.

Temple R, Ellenberg SS.

Ann Intern Med. 2000 Sep 19;133(6):455-63.PMID: 10975964 [PubMed - indexed for MEDLINE]Related articlesFree article

Select-drop designs in clinical trials.

Ellenberg SS.

Am Heart J. 2000 Apr;139(4):S158-60. No abstract available. PMID: 10740123 [PubMed - indexed for MEDLINE]Related articles

Neonatal deaths after hepatitis B vaccine: the vaccine adverse event reporting system, 1991-1998.

Niu MT, Salive ME, Ellenberg SS.

Arch Pediatr Adolesc Med. 1999 Dec;153(12):1279-82.PMID: 10591306 [PubMed - indexed for MEDLINE]Related articlesFree article

Report of a US public health service workshop on hypotonic-hyporesponsive episode (HHE) after pertussis immunization.

Braun MM, Terracciano G, Salive ME, Blumberg DA, Vermeer-de Bondt PE, Heijbel H, Evans G, Patriarca PA, Ellenberg SS.

Pediatrics. 1998 Nov;102(5):E52.PMID: 9794982 [PubMed - indexed for MEDLINE]Related articles

Two-year review of hepatitis A vaccine safety: data from the Vaccine Adverse Event Reporting System (VAERS).

Niu MT, Salive M, Krueger C, Ellenberg SS.

Clin Infect Dis. 1998 Jun;26(6):1475-6. No abstract available. PMID: 9636890 [PubMed - indexed for MEDLINE]Related articles

Comparative safety of two recombinant hepatitis B vaccines in children: data from the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD).

Niu MT, Rhodes P, Salive M, Lively T, Davis DM, Black S, Shinefield H, Chen RT, Ellenberg SS.

J Clin Epidemiol. 1998 Jun;51(6):503-10.PMID: 9635999 [PubMed - indexed for MEDLINE]Related articles

Informed consent: protection or obstacle? Some emerging issues.

Ellenberg SS.

Control Clin Trials. 1997 Dec;18(6):628-36; discussion 661-6. Review.PMID: 9408725 [PubMed - indexed for MEDLINE]Related articles

Descriptive epidemiology of adverse events after immunization: reports to the Vaccine Adverse Event Reporting System (VAERS), 1991-1994.

Braun MM, Ellenberg SS.

J Pediatr. 1997 Oct;131(4):529-35.PMID: 9386653 [PubMed - indexed for MEDLINE]Related articles

Syncope after immunization.

Braun MM, Patriarca PA, Ellenberg SS.

Arch Pediatr Adolesc Med. 1997 Mar;151(3):255-9.PMID: 9080932 [PubMed - indexed for MEDLINE]Related articles

HIV vaccines.

Ellenberg SS, Rida WN.

Lancet. 1997 Feb 1;349(9048):361. No abstract available. PMID: 9024406 [PubMed - indexed for MEDLINE]Related articles

The complicated task of monitoring vaccine safety.

Ellenberg SS, Chen RT.

Public Health Rep. 1997 Jan-Feb;112(1):10-20; discussion 21. Review.PMID: 9018282 [PubMed - indexed for MEDLINE]Related articlesFree article

The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials.

DeMets DL, Fleming TR, Whitley RJ, Childress JF, Ellenberg SS, Foulkes M, Mayer KH, O'Fallon J, Pollard RB, Rahal JJ, et al.

Control Clin Trials. 1995 Dec;16(6):408-21.PMID: 8720018 [PubMed - indexed for MEDLINE]Related articles

A trial of RSV immune globulin in infants and young children: the FDA's view.

Ellenberg SS, Epstein JS, Fratantoni JC, Scott D, Zoon KC.

N Engl J Med. 1994 Jul 21;331(3):203-5. No abstract available. PMID: 8054049 [PubMed - indexed for MEDLINE]Related articles

New designs for the selection of treatments to be tested in randomized clinical trials.

Simon R, Thall PF, Ellenberg SS.

Stat Med. 1994 Mar 15-Apr 15;13(5-7):417-29. Review.PMID: 8023026 [PubMed - indexed for MEDLINE]Related articles

The utility of large, simple trials in the evaluation of AIDS treatment strategies.

Ellenberg SS, Foulkes MA.

Stat Med. 1994 Mar 15-Apr 15;13(5-7):405-15. Review. No abstract available. PMID: 7912842 [PubMed - indexed for MEDLINE]Related articles

Community-based HIV trials are rigorous, says NIH.

Foulkes MA, Deyton LR, Ellenberg SS.

Ann Intern Med. 1993 Nov 1;119(9):956-7. No abstract available. PMID: 8215014 [PubMed - indexed for MEDLINE]Related articlesFree article

Surrogate endpoints.

Ellenberg SS.

Br J Cancer. 1993 Sep;68(3):457-9. No abstract available. PMID: 8353034 [PubMed - indexed for MEDLINE]Related articlesFree article

The use of external monitoring committees in clinical trials of the National Institute of Allergy and Infectious Diseases.

Ellenberg SS, Myers MW, Blackwelder WC, Hoth DF.

Stat Med. 1993 Mar;12(5-6):461-7; discussion 469.PMID: 8493424 [PubMed - indexed for MEDLINE]Related articles

Studying treatments for AIDS: new challenges for clinical trials--a panel discussion at the 1990 annual meeting of the Society for Clinical Trials.

Ellenberg SS, Cooper E, Eigo J, Finkelstein DM, Hoth DF, Nusinoff-Lehrman S, Sacks H.

Control Clin Trials. 1992 Aug;13(4):272-92. No abstract available. PMID: 1330433 [PubMed - indexed for MEDLINE]Related articles

Do large, simple trials have a place in the evaluation of AIDS therapies?

Ellenberg SS.

Oncology (Williston Park). 1992 Apr;6(4):55-9, 63; discussion 63-4. Review.PMID: 1533781 [PubMed - indexed for MEDLINE]Related articles

Randomized consent designs for clinical trials: an update.

Ellenberg SS.

Stat Med. 1992 Jan 15;11(1):131-2. No abstract available. PMID: 1557570 [PubMed - indexed for MEDLINE]Related articles

Surrogate end points in clinical trials.

Ellenberg SS.

BMJ. 1991 Jan 12;302(6768):63-4. No abstract available. PMID: 1671650 [PubMed - indexed for MEDLINE]Related articlesFree article