title_gcrc

Articles can also be accessed through Columbia University Libraries.

Authors

Title

References

Links

Blackwelder WC

Showing a treatment is good because it is not bad: when does "noninferiority" imply effectiveness?

Control Clin Trials. 2002 Feb;23(1):52-4.

PubMed

Blackwelder WC

"Proving the null hypothesis" in clinical trials

Control Clin Trials. 1982 Dec;3(4):345-53

PubMed

Connolly SJ

Use and misuse of surrogate outcomes in arrhythmia trials

Circulation. 2006 Feb 14;113(6):764-6.

PubMed

Dupont WD, Plummer WD Jr

Power and sample size calculations. A review and computer program.

Control Clin Trials. 1990 Apr;11(2):116-28.

PubMed

Dupont WD, Plummer WD Jr

PS: Power and Sample Size Calculation software.

Vanderbilt Biostatistics

Software

D'Agostino RB Sr, Massaro JM, Sullivan LM

Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics.

Stat Med. 2003 Jan 30;22(2):169-86.

PubMed

Farcomeni A

A review of modern multiple hypothesis testing, with particular attention to the false discovery proportion.

Stat Methods Med Res. 2008 Aug;17(4):347-88. Epub 2007 Aug 14. Review

PubMed
Columbia University Libraries

Geller NL, Pocock SJ

Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners.

Biometrics. 1987 Mar;43(1):213-23.

JSTOR

Hoenig JM and Heisey DM

The Abuse of Power: The Pervasive Fallacy of Power Calculations for Data Analysis.

The American Statistician.  2001; 55(1): 19-24.

JSTOR

Hwang IK, Morikawa T

Design issues in non-inferiority / equivalence trials.

Drug Inf J. 1999;33:1205–18.

Link

Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA

Caution regarding the use of pilot studies to guide power calculations for study proposals.

Arch Gen Psychiatry. 2006 May;63(5):484-9.

PubMed

McFadden ET

Data Management and Coordination.

Encyclopedia of Biostatistics.  2005.  Editors-in-chief Peter Armitage & Theodore Colton. Hoboken, NJ: Wiley Interscience.

 

Meier P

Statistics and medical experimentation.

Biometrics. 1975 Jun;31(2):511-29.

JSTOR

Meinert CL

Clinical Trials, Overview.

Encyclopedia of Biostatistics.  2005.  Editors-in-chief Peter Armitage & Theodore Colton. Hoboken, NJ: Wiley Interscience.


Moher D, Schulz KF, Altman DG; CONSORT GROUP (Consolidated Standards of Reporting Trials)

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. 

Ann Intern Med. 2001 Apr 17;134(8):657-62. Review.

PubMed
CONSORT

Moore CG, Carter RE, Nietert PJ, Stewart PW

Recommendations for planning pilot studies in clinical and translational research.

Clin Transl Sci. 2011 Oct;4(5):332-7.

PubMed

Pocock SJ

Statistical aspects of clinical trial design.

The Statistician 1982; 31(1): 1-18.

JSTOR

Potter DM

Adaptive dose finding for phase I clinical trials of drugs used for chemotherapy of cancer.

Stat Med. 2002 Jul 15;21(13):1805-23.

PubMed

Senn S

Some controversies in planning and analysing multi-centre trials. 

Stat Med. 1998 Aug 15-30;17(15-16):1753-65; discussion 1799-800. Review.

PubMed
Discussion by Peter R. Freeman

Senn S

Crossover Designs.

Encyclopedia of Biostatistics.  2005.  Editors-in-chief Peter Armitage & Theodore Colton. Hoboken, NJ: Wiley Interscience.


Siegel JP

Equivalence and noninferiority trials.

Am Heart J. 2000 Apr;139(4):S166-70.

PubMed

Simon R & Thall PF

Phase II Trials.

Encyclopedia of Biostatistics.  2005.  Editors-in-chief Peter Armitage & Theodore Colton. Hoboken, NJ: Wiley Interscience.


Snapinn SM

Noninferiority trials.

Curr Control Trials Cardiovasc Med. 2000;1(1):19-21.

PubMed

Stewart PW

GCRC Protocols Which Propose "Pilot Studies."

2004.  Cincinnati Children’s Hospital.

Link

Storer BE

Phase I Trials.

Encyclopedia of Biostatistics.  2005.  Editors-in-chief Peter Armitage & Theodore Colton. Hoboken, NJ: Wiley Interscience.


Van Oortmarssen GJ

Screening, Overview.

Encyclopedia of Biostatistics.  2005.  Editors-in-chief Peter Armitage & Theodore Colton. Hoboken, NJ: Wiley Interscience.


von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative.

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. 

Ann Intern Med. 2007 Oct 16;147(8):573-7. Erratum in: Ann Intern Med. 2008 Jan 15;148(2):168.

PubMed
STROBE statement link.

Ware JH, Antman EM

Equivalence trials.

N Engl J Med. 1997 Oct 16;337(16):1159-61.

PubMed

Wittes J

Adaptive Designs for Clinical Trials. 

Encyclopedia of Biostatistics.  2005.  Editors-in-chief Peter Armitage & Theodore Colton. Hoboken, NJ: Wiley Interscience.


Wiens BL

Choosing an equivalence limit for noninferiority or equivalence studies.

Control Clin Trials. 2002 Feb;23(1):2-14.

PubMed

Wright JG

The minimal important difference: who's to say what is important?

J Clin Epidemiol. 1996 Nov;49(11):1221-2.

PubMed