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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
Columbia University Libraries

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
Columbia University Libraries

Dupont WD, Plummer WD Jr

PS: Power and Sample Size Calculation software.

Vanderbilt Biostatistics

Software

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
Columbia University Libraries

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
Columbia University Libraries

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
Columbia University Libraries

McFadden ET

Data Management and Coordination.

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

Columbia University Libraries

Meier P

Statistics and medical experimentation.

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

JSTOR
Columbia University Libraries

Meinert CL

Clinical Trials, Overview.

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

Columbia University Libraries

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

Pocock SJ

Statistical aspects of clinical trial design.

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

JSTOR
Columbia University Libraries

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
Columbia University Libraries

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
Columbia University Libraries
Discussion by Peter R. Freeman
Columbia University Libraries

Senn S

Crossover Designs.

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

Columbia University Libraries

Simon R & Thall PF

Phase II Trials.

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

Columbia University Libraries

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.

Columbia University Libraries

Van Oortmarssen GJ

Screening, Overview.

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

Columbia University Libraries

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.

Wittes J

Adaptive Designs for Clinical Trials. 

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

Columbia University Libraries

Wright JG

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

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

PubMed
Columbia University Libraries