Annotated Bibliography

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INTRODUCTION

This annotated bibliography is designed to offer biostatisticians, statisticians, epidemiologists, and others a comprehensive review of articles about ethical practice. The contributors are members of the Working Group on the Ethical Practice of Biostatistics and Epidemiology in Clinical and Translational Research. This working group is part of the Biostatistics, Epidemiology, and Research Design committee of the NIH Clinical and Translational Science Consortium. The selection criteria are broad, restricted only to peer-reviewed published works and conference proceedings that are accessed easily via the internet. The goal is to be comprehensive and to provide a convenient place for practitioners to find articles relevant to their day-to-day practice, and relevant to ethical dilemmas they may face in their work.

Requested elements include the title, authors, bibliographic citation, internet link, annotation, submitter's name and institutional affiliation. The annotations should describe the reason the selection was chosen and its relevance to the field. Special note should be given to debates or issues that are highlighted in the selection.

PLEASE click on title to see all the information about the article.

References for Ethics in Biostatistical Practice

Title	Author	Web Access Paper	Contributed by
Adaptive designs for binary treatment responses in phase III clinical trials: controversies and progress	Atanu Biswas	http://www.ncbi.nlm.nih.gov/pubmed/11697227	John Lantos, KU/Frontiers
Are large clinical trials in rapidly lethal diseases usually unethical?	Horrrobin, DF	http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2803%2912571-8/fulltext [proprietary]	Peter Bacchetti
Clinical Trials--Are They Ethical?	Passamani E.		Ronald Thisted, University of Chicago
Ethical and Professional Expectations in Scientific Publication	Peter B. Imrey	http://bulletin.imstat.org/wp-content/uploads/Bulletin39_2.pdf	Shelley Hurwitz
Ethics and Statistics in Randomized Clinical Trials	Royall RM	http://www.jstor.org/stable/pdfplus/2245703.pdf	Ronald Thisted, University of Chicago
Ethics and sample size.	Bacchetti P, Wolf LE, Segal MR, McCulloch CE	http://aje.oxfordjournals.org/content/161/2/105.full	Peter Bacchetti
Hellman S, Hellman DS.Problems of the Randomized Clinical Trial	Hellman S, Hellman DS		Ronald Thisted, University of Chicago
Impact of a Scientific Presentation on Community Treatment Patterns for Primary Breast Cancer	Giordano, S. H., Z. Duan, et al.	http://jnci.oxfordjournals.org/content/98/6/382.full	Chris Lindsell, U of Cincinnati
Problems of stopping trials early.	Guyatt GH, Briel M, Glasziou P, Bassler D, Montori VM	http://www.ncbi.nlm.nih.gov/pubmed/22705814	Erin E. Fox, PhD, University of Texas Health Science Center at Houston
Statistics and ethics in medical research Misuse of statistics is unethical	Altman D.G.	http://www.bmj.com/content/281/6249/1182	Michael Brimacombe PhD, KUMC - KU
The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials	Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, et al	http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001346	Elizabeth Heitman, PhD
The continuing unethical conduct of underpowered clinical trials	Halpern SD, Karlawish JHT, Berlin JA	http://jama.jamanetwork.com/article.aspx?articleid=195126#qundefined [proprietary]	Peter Bacchetti

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