Skip Over Navigation LinksNational Institutes of HealthMoving from observational studies to clinical trials: why do we sometimes get it wrong?

National Institutes of Health · Building 1, Wilson Hall · January 11-12, 2005

   
 
   
   

References

Methodology related to the analysis of observational studies:

Baker SG, Lindeman KL, and Kramer, BS The paired availability design for historical controls BMC Medical Research Methodology 2001, 1:9. http://www.biomedcentral.com/1471-2288/1/9

Rubin DB Estimating causal effects from large data sets using propensity scores ANN INTERN MED 127 (8): 757-763 Part 2 OCT 15 1997

Baker, SG and Lindeman, K.L. Rethinking historical controls. Biostatistics 2001,2: 383-396. [Some of this is a bit technical, but it includes a comparison of results from paired availability design, propensity score, and a meta-analysis of randomized trials]

Baker SG and Kramer, BS Good for women, good for men, bad for people: Simpson's paradox and the importance of sex-specific analysis in observational studies. Journal of Women's Health & Gender-Based Medicine 2001, 10, 867 - 872. [Graphical view of Simpson's Paradox]

Methodology related to randomized trials

Baker SG and Kramer BS The transitive fallacy for randomized trials: If A bests B and B bests C in separate trials, is A better than C? BMC Medical Research Methodology 2002, BMC Medical Research Methodology 2002, 2:13 http://www.biomedcentral.com/1471-2288/2/13

Baker SG and Kramer BS. Randomized trials, generalizability, and meta-analysis: Graphical insights for binary outcomes. BMC Medical Research Methodology 2003, 3:10 http://www.biomedcentral.com/1471-2288/3/10

The fallacy of enrolling only high-risk subjects in cancer prevention trials: Is there a "free lunch"?

Stuart G Baker, Barnett S Kramer and Donald Corle BMC Medical Research Methodology 2004, 4:24 (04 Oct 2004) http://www.biomedcentral.com/1471-2288/4/24

Moses LE, Mosteller F, Buehler JH Comparing results of large clinical trials to those of meta-analyses Statistics In Medicine 21 (6): 793-800 MAR 30 2002

Baker, SG and Freedman LS. A simple method for analyzing data from a randomized trial with a missing binary outcome. BMC Medical Research Methodology 2003, 3:8 http://www.biomedcentral.com/1471-2288/3/8
Correction: http://www.biomedcentral.com/1471-2288/4/1

Methodology related to surrogate endpoints

Baker SG and Kramer BS. A perfect correlate does not a surrogate make BMC Medical Research Methodology 2003, 3:16 http://www.biomedcentral.com/1471-2288/3/16

Methodology for evaluating cancer screening

Baker SG, Kramer BS, and Prorok, PC. Statistical issues in randomized trials of cancer screening. BMC Medical Research Methodology 2002, 2:11 http://www.biomedcentral.com/1471-2288/2/11 [Cancer screening trials require special analytic techniques]

Baker SG, Erwin D, Kramer BS, Prorok, PC. Using observational data to estimate an upper bound on the reduction in cancer mortality due to periodic screening, BMC Medical Research Methodology 2003, 3:4 (06 Mar 2003) http://www.biomedcentral.com/1471-2288/3/4

Baker SG, Kramer BS, and Prorok PC. Comparing cancer mortality rates before-and-after a change in availability of screening in different regions: Extension of the paired availability design. BMC Medical Research Methodology 2004, 4:12. http://www.biomedcentral.com/1471-2288/4/12

Baker SG and Kramer BS. Estimating the Cumulative Risk of False Positive Cancer Screenings. BMC Medical Research Methodology 2003, 3:11http://www.biomedcentral.com/1471-2288/3/11

Methodology related to validation of biomarkers

Baker SG, Kramer, BS and Srivastava, S. Markers for early detection of cancer: Statistical issues for nested case-control studies. BMC Medical Research Methodology 2002, 2:4, http://www.biomedcentral.com/1471-2288/2/4/.

Baker SG, Kramer BS, and Prorok PC. Development tracks for cancer prevention markers. Disease Markers 2004, 20:97-102

Baker SG. Kramer BS. Biomarkers, surrogate endpoints, and early detection imaging tests: reducing confusion. International Chinese Statistical Association Bulletin. January 2004 http://www.icsa.org/bulletin/Bulletin-1-2004-Contents/A3-25-controverstial-issues-v4.doc

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